A Double-Blind, Placebo-Controlled Randomized Evaluation of the Effect of the Erchonia FX-635 on Low Back Pain
Phase: NA
Conditions: Low Back Pain
Sponsor: Erchonia Corporation

 
 
 
 
 
 
 
 
 
ERCHONIA® FX-635™ 
 
 
A double-blind, placebo-controlled  
randomized evaluation of the effect  
of the Erchonia® FX-635™on  
 low back pain clinical study protocol 
 
 
 
 
 
 
ERCHONIA CORPORATION 
 
 
 
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Erchonia® FX-635™ Low Back Pain Clinical Study Protocol  
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STUDY INFORMATION 
 
 
PURPOSE OF STUDY 
The purpose of this clinical study is to determine the effectiveness of the Erchonia® FX-635™, 
manufactured by Erchonia Corporation (the Company), in providing temporary acute relief of minor 
episodic chronic low back pain of musculoskeletal origin. 
 
STUDY DURATION 
The estimated total duration of the study is four to five months. 
 
INDICATION FOR USE 
The indication (claim) being sought through support of the results of this clinical study is: “The 
Erchonia® FX-635™ is indicated for adjunctive use in providing temporary acute relief of minor 
episodic chronic low back pain of musculoskeletal origin.”  
 
It is intended that the results of this clinical study be used to support a 510(k) submission to FDA 
for clearance to market the device for the intended indication. 
 
EXPECTED RESULTS 
Following completion of the study procedure administration protocol with the Erchonia® FX-635™, 
it is anticipated that compared with baseline, a significantly greater proportion of subjects in the test 
group than in the placebo group will show a 30% or greater reduction in self-reported low back pain 
VAS rating at study endpoint evaluation. 
 
 
 
 

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DEVICE INFORMATION: ERCHONIA® FX-635™ 
 
DEVICE DESCRIPTION & DETAILS 
 
The Erchonia® FX-635™ used in this study is made up of 3 independent 17 mW, 635 nm red laser 
diodes mounted in scanner devices with flexible arms positioned equidistant from each other.  
 
The Erchonia® FX-635™ is a variable hertz device. The variable hertz feature of the Erchonia® 
FX-635™ is a pulsed wave, defined as containing a selected series of breaks, variances that are 
preprogrammed. 
   
The Erchonia® FX-635™ utilizes internal mechanics that collects the light emitted from each of the 
laser diodes and processes each through a proprietary patented lens which redirects the beam with 
a line refractor. The refracted light is then bent into a spiraling circle pattern that is totally random 
and independent of the other diodes.  
 
The Erchonia® FX-635™ has the following specifications:   
 
✓  Configuration: Class 2 Line Generated Laser Diode Modules 
✓  Wavelength: 635 nm  
✓  Power Output (Mean): 17 mW 
✓  Modulation: Pulsed Wave (50% duty Cycle) 
✓  Display: Full Color TFT Touch Screen Control Center 
✓  Adjustments: 
•      44” Vertical Arm Height Adjustment. 
•      Three Independent Adjustable Arms 
✓  Power Source: 100-240 VAC 50-60 Hz 
✓  Chassis: 
•      Metal Frame Powder Coated for Ease of Cleaning 
•      4 Anti-Static Casters (4 Locking) 
✓  Housing: Black Carbon Fiber Finish Thermoformed from Non-Allergen Material/Plastic 
✓  Weight: 70 lbs. 
 
Dosage calculations for the Erchonia® FX-635™ 
 
Equations:  
1) Intensity = W/cm2  
2) Dosage = (J/cm2)=(W/cm2) x τ(s)  
3) Oval Surface area = π x (r1/2) x (r2/2)  
MW = miliwatts  
W= Watts 
 
Intensity:  
Intensity ÷ oval surface area = intensity at tissue  
1) 17.5 mW / 1000 = 0.0175 W (Intensity conversion from mW to W)  
2) π x (9cm/2) x (9.5cm/2) = 21.375 cm2 (surface area of treated region at single diode at 
3.5” above the skin surface.  
3) 0.0175 / 21.375 cm2 = 8.2 x10-4 W/cm2 (intensity for single diode at skin)  
4) 8.2 x 10-4 W/cm2 x (3 diodes) = 2.46 x10-3 W/cm2 (intensity for all 3 diodes combined at the 
skin)  
 

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Dosage delivered to the skin:  
Intensity x τ(s) = dosage at specific area  
1) 2.46 x 10-3 W/cm2 x (900 seconds) = .0865 J/cm2 (total dosage delivered to the skin) 
 
The Erchonia® FX-635™ used in this study is shown in Figures 1 and 2 below. 
 
 
 
 
Figure 1: Erchonia® FX-635™ 
Figure 2: Erchonia® FX-635™ 

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The Erchonia® FX-635™ System Components is shown in Figures 3 and 4 below. 
 
 
 
Figure 3: Erchonia® FX-635™ System Components 
 
1. Power Safety Lockout Key 
2. Touch Screen 
3. Main Upright of Base 
4. Power Inlet/Fuse Holder 
5. Arm Lock (Fig. 2) 
6. Wheel Lock 
7. Boom Arm 
  8. Center Head Adjustment Knob 
  9. Laser Head Assembly 
10. Upper Arms 
11. Upper/Lower Pivots 
12. Laser Output Heads 
13. Locking Knob – not shown 
14. Power Cord – not shown 
15. Electrical Connector – not shown 
 
 
POWER SAFETY LOCKOUT KEY (1) 
The Power Safety Lockout Key is the outwardly visible portion of an internal locking mechanism on 
top of the touch screen [2] that comes with an external key.  Together they allow the end user to 
turn the device ON or OFF.  (“O” = OFF and “|” = ON) In the OFF position the device is locked. 
 
TOUCH SCREEN (2) 
The touch screen functions as a display screen and an input panel, providing information to the 
user and a means to operate the device by touching the appropriate icon. 
 
MAIN UPRIGHT OF BASE (3) 
The main upright of base supports the boom arm and contains the electrical connector (See Setup) 
and the Locking Knob [13]. 
 
 

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POWER INLET/FUSE HOLDER (4) 
The device contains an appliance coupler (power inlet) and a flexible detachable power cord 
[14].  This is the location on the device where the power cord is connected. 
 
ARM LOCK (5) 
The Arm Lock is the black lever attached to the side of the Boom Arm.  This is a secondary locking 
mechanism for the boom arm.  The arm tension can be adjusted or locked into position with the 
arm lock lever.   
 
WHEEL LOCKS (6) 
The device includes four antistatic wheels that enable ease for maneuverability.  Once the device 
is transported to the desired location the wheel locks can be engaged to eliminate excessive 
movement of the device. 
 
BOOM ARM (7) 
The Boom Arm serves to position the Laser Head Assembly [9] vertically only.  It is designed to 
adjust by intentional force from the end user.  This allows the end user to lower and raise the Laser 
Output Heads for proper positioning to patient for accurate treatment distance. 
 
CENTER HEAD ADJUSTMENT KNOB (8) 
The Center Head Adjustment Knob [8] serves to adjust the treatment height of the center head.  This 
also acts as the locking mechanism for the center head.   
 
LASER HEAD ASSEMBLY (9) 
This three-head assembly located on the end of the laser arm (boom arm) accommodates the laser 
output heads, pivots, arms and center head adjustment knob.  This assembly can be rotated 120 
degrees for proper positioning to patient for accurate treatment. 
 
UPPER ARMS (10) 
The upper arms serve as a positioning support for Laser Output Heads [12].  It is designed to adjust 
by intentional force from the end user.  This allows the end user to lower and raise the Laser Output 
Heads for proper positioning to patient for accurate treatment distance. 
 
UPPER/LOWER PIVOTS (11) 
The upper and lower pivots serve as a positioning support for Laser Output Heads [12].  It is 
designed to adjust by intentional force from the end user.  This allows the end user to move the 
laser output heads in and out, as well as side to side for proper positioning to patient for accurate 
treatment distance. 
 
LASER OUTPUT HEADS (12) 
The three plastic housings located on the end of the Lower Pivots [11] as well as the center of laser 
head assembly [9], accommodates the lens, laser diodes, motors, and their associated 
electronics.  The side heads are designed to adjust by intentional force from the end user; this 
allows the end user to change the angle of the laser output heads for proper positioning to patient 
for accurate treatment distance.  The center head is designed to be adjusted by center head 
adjustment knob [8]. 
 
LOCKING KNOB (13) 
The locking Knob is utilized to secure the two-piece assembly [3 & 7], also preventing the boom 
arm assembly from unwanted rotation during use. 
 

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POWER CORD (14) 
The device contains a flexible detachable power cord.   
 
ELECTRICAL CONNECTOR (15) 
The electrical connector is a two-piece assembly.  The electrical connector connects the main head 
assembly to the base assembly in order to transfer data and power. 
 
This pictorial shows the simple 2-piece assembly 
of the scanner.  This assembly is best done with 2 
people. 
 
The 2 major components are the arm [7] and base 
[3]. 
 
Figure 4: Erchonia® FX-635™ Assembly 
 
 
 
 

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DEVICE SAFETY 
 
RISK AND PREVENTION OF EYE INJURY 
The Erchonia® FX-635™ is classified by the FDA/IEC as a Class 2 laser device. This designation 
represents a current standard for use in order to ensure the safety of the subject. A Class 2 laser is 
determined to have a chronic viewing hazard. Pointing the laser beam directly into the eye and 
maintaining it there for an extended period of time could prove to be damaging. 
 
To ensure there is no possible instance of residual effect, eye protection is implemented for both 
the investigator administering the study procedures with the Erchonia® FX-635™ Laser and for the 
subject receiving the laser procedure administrations. 
 
A pair of specialty safety glasses is provided for use during all procedure applications. These safety 
glasses are Laser Safety Industries PN: 100-40-240 light blue safety glasses. These safety glasses 
have the following specifications: 
 
✓  OD 4+ @ 630-690 nm 
✓  OD 7+ @ 690-970 nm 
✓  OD 5+ @ 970-1100 nm 
✓  VLT 36% 
 
The Laser Safety Industries PN: 100-40-240 light blue safety glasses are shown in Figures 5 & 6 
below. 
 
Figures 5 & 6: Laser Safety Industries PN: 100-40-240 Safety Glasses* 
*The block out glasses is specifically for the clinical trial 
 

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STUDY INDICATION, THEORY OF MECHANISM OF OPERATION, & SUPPORTING 
MATERIALS 
STUDY 
INDICATION: 
MINOR 
EPISODIC 
CHRONIC 
LOW 
BACK 
PAIN 
OF 
MUSCULOSKELETAL ORIGIN  
 
The study indication to be evaluated in this study is the temporary acute relief of minor episodic 
chronic low back pain of musculoskeletal origin. 
 
STATISTICS 
Around $50 billion is spent in the U.S. each year on low back pain, the most common cause of job-
related disability and a leading contributor to missed work. Back pain is the second most common 
neurological ailment in the United States, second only to headache.  
 
Over a lifetime, 80% of people have lower back pain, with 26% of American adults reporting pain of 
at least one day in duration every three months. 41% of adults aged between 26 and 44 years 
reported having back pain in the previous 6 months. Men and women are equally affected. It occurs 
most frequently between ages 30 and 50, due in part to the aging process but also as a result of 
sedentary life styles with too little (sometimes punctuated by too much) exercise.  
 
DESCRIPTION & DEFINITION 
Low back pain is a common musculoskeletal disorder affecting 80% of people at some point in their 
lives. 
 
➢ Anatomy of the back 
The lumbar region (lower back region) is comprised of five 
vertebrae (L1-L5). In between these vertebrae lie 
fibrocartilage discs (intervertebral discs), which act as 
cushions, preventing the vertebrae from rubbing together 
while at the same time protecting the spinal cord. Nerves 
stem from the spinal cord through foramina within the 
vertebrae, providing muscles with snsations and motor 
associated messages. Stability of the spine is provided 
through ligaments and muscles of the back, lower back 
and abdomen. Small joints which prevent, as well as 
direct, motion of the spine are called facet joints 
(zygapophysial joints). 
 
➢ Etiologies of low back pain 
The vast majority of low back pain (with many estimates as high as 99% incidence) stems from 
benign musculoskeletal problems, referred to as non-specific low back pain (meaning that the 
precise cause can be difficult to determine) – the etiology being evaluated in this study. It is caused 
by lumbar sprain or strain a stretch injury to the ligaments, tendons, and/or muscles of the low 
back. The stretching incident results in microscopic tears of varying degrees in the soft tissues of 
the lower back. The injury can occur because of overuse, improper use or trauma. A diagnosis of 
nonspecific low back pain occurs in the absence of any serious underlying pathology or nerve root 
compromise. 
 
Other etiologies of low back pain that are not being evaluated in this study include the following: 
✓ Mechanical: Apophyseal osteoarthritis; diffuse idiopathic skeletal hyperostosis; degenerative 
discs; Scheuermann's kyphosis; s ("slipped disc"); thoracic or lumbar spinal stenosis; 

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spondylolisthesis and other congenital abnormalities; fractures; leg length difference; restricted 
hip motion; misaligned pelvis - pelvic obliquity; anteversion or retroversion; and abnormal foot 
pronation  
✓ Inflammatory: Seronegative spondylarthritides (e.g. ankylosing spondylitis); rheumatoid arthritis; 
infection - epidural abscess or osteomyelitis  
✓ Neoplastic: bone tumors (primary or metastatic); and intradural spinal tumors  
✓ Metabolic: osteoporotic fractures; osteomalacia; ochronosis; and chondrocalcinosis.  
✓ Psychosomatic: Tension myositis syndrome  
✓ Paget's disease  
✓ Referred pain: Pelvic/abdominal disease; prostate cancer; and posture  
✓ Depression 
✓ Oxygen deprivation  
 
➢ Classification of low back pain 
 
✓ Acute low back pain generally lasts from a few days to less than 4 weeks.  
✓ Sub-acute low back pain lasts 4-12 weeks 
✓ Chronic low back pain is defined as pain in the lower back region that persists for more than 
3 months. It is often progressive, and the cause is typically mechanical or non-specific in 
nature; that is, the cause can be difficult to determine.  
 
➢ Presentation of low back pain 
Lumbar sprain strain is characterized by localized discomfort in the low back area with onset after 
an event that mechanically stressed the lumbar tissues. The severity of the injury can range from 
mild to severe, depending on the degree of strain and resulting spasm of the muscles of the low 
back. 
 
➢ Diagnosis 
 
Diagnosis of low back pain 
Medical history and physical exam can usually identify any dangerous conditions or family history 
that may be associated with the low back pain. Factors such as the onset, site, and severity of the 
pain; duration of symptoms and any limitations in movement; and history of previous episodes or 
any health conditions that might be related to the pain are considered. The physician will examine 
the back and conduct neurologic tests to determine the cause of pain and appropriate treatment. 
Blood tests and imaging tests may be performed to rule out more serious sources of the pain such 
as tumors.  
 
Diagnostic methods available to confirm the cause of low back pain include: 
✓ X-ray imaging to look for broken bones or an injured vertebra. Tissue masses such as injured 
muscles and ligaments or painful conditions such as a bulging disc are not visible on 
conventional x-rays.  
✓ Computerized tomography (CT) is used when disc rupture, spinal stenosis, or damage to 
vertebrae is suspected as a cause of low back pain.  
✓ Magnetic resonance imaging (MRI) is used to evaluate the lumbar region for bone degeneration 
or injury or disease in tissues and nerves, muscles, ligaments, and blood vessels.  
✓ Electrodiagnostic procedures include electromyography (EMG), nerve conduction studies, and 
evoked potential (EP) studies to assess the electrical activity in a nerve to detect if muscle 
weakness results from injury or a problem with the nerves that control the muscles.  
 

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CURRENT THERAPEUTIC APPROACHES TO THE MANAGEMENT OF EPISODIC CHRONIC 
LOW BACK PAIN OF MUSCULOSKELETAL ORIGIN   
 
The treatment of lumbar sprain strain centers about reducing pain and inflammation and consists 
of: 
 
✓ resting the back to avoid reinjury, 
✓ medications to relieve pain and muscle spasm such as over-the-counter analgesics, including 
NSAIDs (aspirin, naproxen, and ibuprofen) to reduce stiffness, swelling, and inflammation and 
to ease mild to moderate low back pain; counter-irritants applied topically to the skin as a cream 
or spray stimulate the nerve endings in the skin to provide feelings of warmth or cold and dull 
the sense of pain, and to reduce inflammation and stimulate blood flow; anticonvulsants which 
may be useful in treating certain types of nerve pain; some antidepressants, particularly tricyclic 
antidepressants such as amitriptyline and desipramine; opioids such as codeine, oxycodone, 
hydrocodone, and morphine 
✓ local heat applications 
✓ massage, and  
✓ reconditioning exercises to strengthen the low back and abdominal muscles after healing. 
✓ Spinal manipulation 
 
When back pain does not respond to more conventional approaches, alternative options are 
available, such as: 
 
✓ Acupuncture. It is believed this process triggers the release of naturally occurring painkilling 
molecules called peptides and keeps the body’s normal flow of energy unblocked.  
✓ Biofeedback is used to help the patient learn to effect a change in his or her response to pain, 
for example, by using relaxation techniques. 
✓ Traction involves the use of weights to apply constant or intermittent force to gradually “pull” the 
skeletal structure into better alignment.  
✓ Transcutaneous electrical nerve stimulation (TENS): TENS may also help stimulate the brain’s 
production of endorphins (chemicals that have pain-relieving properties).  
✓ Ultrasound is used to warm the body’s internal tissues, causing the muscles to relax. Sound 
waves pass through the skin and into the injured muscles and other soft tissues.  
 
Alternative therapies for managing chronic low back pain are growing in popularity as they are less 
invasive and without side-effects compared with traditional treatments, especially medications. 
 
Surgical procedures are also a treatment option for low back pain. However, the outcomes are often 
poor and not lasting; yet still, back operations are the 3rd most common form of surgery in the 
United States, with about 300,000 back surgeries performed annually in the U.S. 
 
 

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THEORY OF MECHANISM OF OPERATION OF THE APPLICATION OF LOW LEVEL LASER 
LIGHT USING THE ERCHONIA® FX-635™ TO PROVIDE TEMPORARY ACUTE RELIEF OF 
MINOR EPISODIC CHRONIC LOW BACK PAIN OF MUSCULOSKELETAL ORIGIN     
The scientific principle underlying laser physics was first developed by Albert Einstein in 1916.  
The biological effects of low-level laser therapy (LLLT) have been studied for forty years all around 
the globe, and no unwanted side effects have been noted anywhere. The safety record is strong.  
 
All the cells in the body have receptors on their cell membranes that are able to read different 
frequencies of energy contained in the electromagnetic spectrum. This spectrum includes 
ultraviolet, infrared, and visible light. Soft (low-level) lasers produce visible and infrared light. The 
different frequencies of light communicate information to the cells that is understood by the 
receptors on the membrane of the cell and on the membrane of the cell’s mitochondrion (the 
enzymatic engine of the cell). This energetic information eventually reaches the cell’s DNA, which 
directly controls cell function. 
 
When the cells are able to receive better information, they work better. When cells function better 
so do the tissues that they comprise, like bones, cartilage, tendons, ligaments, etc. In this way, 
LLLT promotes the healing and regeneration of damaged tissues. The energy from soft lasers is 
able to affect every tissue and system in the body. Scientists have shown that soft laser light is able 
to penetrate into the body; research has demonstrated that it has both local effects on tissue 
function and also systemic effects that are carried throughout the body by the blood and possibly 
also by acupuncture meridians. 
 
The key basic physiological effects of low level laser light include: 
 
1) increased cell membrane polarization and permeability 
2) increased ATP production and respiratory chain activity 
3) increased enzyme activity 
4) increased collagen and epithelial production 
5) increased capillary formation 
6) increased macrophage (immune) activity 
7) analgesic effects due to elevated endorphin production, electrolytic nerve blockage, and 
improved blood and lymph flow 
8) anti-inflammatory effect due to improved circulation and accelerated tissue regeneration; and 9) 
increased production of antioxidants. 
 
Of additional benefit is that light energy from low level lasers will only be absorbed by those cells 
and tissues that are not functioning normally and that need it. Soft laser light has no effect on healthy 
cells. 
 

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SUPPORTING MATERALS 
 
➢ Comparison of the effect of laser and magnetic therapy for pain level and the range of 
motion of the spine of people with osteoarthritis lower back]. 
Zdrodowska B, Leszczyńska-Filus M, Leszczyński R, Błaszczyk J. 
Pol Merkur Lekarski. 2015 Jan;38(223):26-31 
 
Increased expression of degenerative disease of the lumbar spine is an onerous task, which 
reduces the efficiency of the activity and life of many populations. It is the most common cause of 
medical visits. In 95% of cases the cause of complaints is a destructive process in the course of 
degenerative intervertebral disc called a lumbar disc herniation. Protrusion of the nucleus pulposus 
causes severe pain and impaired muscle tone, often more chronic and difficult to master. 
Successful treatment of lumbar disc herniation constitutes a serious interdisciplinary problem. It is 
important to properly planned and carried out physiotherapy. Based on the number of non-invasive 
methods, to reduce muscle tension, mute pain and alleviation of inflammation. It is the treatment 
safe, effective, and at the same time, which is their big advantage, readily available and cheap. It 
is worth noting that not every method has the same efficiency. The question that the methods are 
effective in relieving pain and helping to effectively increase the range of motion led to a comparison 
of two methods - Low Level Laser Therapy (LLLT) and pulsating magnetic field therapy. 
 
AIM: The aim of the study was to compare the efficacy of LLLT and pulsating magnetic field therapy 
in combating pain and increase range of motion of the spine of people with degenerative spine 
disease of the lower back. 
 
MATERIALS AND METHODS: 120 patients with diagnose lumbar disc herniation whit no nerve 
roots symptoms. Patients were divided into two Groups: A and B. Group A of 60 patients were 
subjected to laser therapy (λ=820nm, P=400mW, Ed=6-12 J/cm²) and the second Group B of 60 
patients too, to pulsating magnetic fields procedures (5mT, 30 Hz, 15 minutes). Every patient 
before rehabilitation started and right after it has finished has undergone examination. Subjective 
pain assessment was carried out using a modified Laitinen questionnaire and Visual Analogue 
Scale of Pain intensity. Spine mobility was evaluated whit the Schober test and the Fingertip-to-
floor-test. The obtained results were subjects to statistical analysis. 
 
RESULTS: Research shows that both low energy laser and pulsating magnetic field physical 
attributes are effective methods for the treatment of pain and restricted mobility of the spine caused 
by disc herniation. Careful analysis emphasizes greater efficiency laser for pain. In contrast, a 
statistically greater improvement in global mobility of the spine, as well as flexion and extension of 
the lumbar recorded in group B, where the applied pulsating magnetic field. 
 
CONCLUSIONS: Both laser and magnet therapies reduce pain and improves mobility of the 
spine of people with degenerative spine disease of the lower back. Comparison of the 
effectiveness of both methods showed a greater analgesic effect of laser treatment, and greater 
mobility of the spine was observed under the influence of pulsating magnetic field therapy. 
PMID: 25763584 
 
 
 
 
 
 

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➢ Tri-length laser therapy associated to tecar therapy in the treatment of low-back pain in 
adults: a preliminary report of a prospective case series. 
Osti R, Pari C, Salvatori G, Massari L. 
Lasers Med Sci. 2015 Jan;30(1):407-12.  
 
Low-back pain is very frequent, especially in active adult population. There are several different 
orthopaedic condition that can cause low-back pain, and the pain worsen the quality of life 
significantly. The treatments vary from drugs, physical therapies, kinesiology, local infiltrations, and 
so on.Laser therapy has an important role in the treatment of the inflammatory causes of pain, with 
several studies that demonstrate the efficacy of low and high energy laser therapy in the treatment 
of low-back pain. Sixty-six consecutive patients with low-back pain with or without leg pain were 
treated using a combination of Tri-length laser I-Triax® (Mectronic Medicale, Bergamo, Italy) and 
Pharon® tecar therapy (Mectronic Medicale, Bergamo, Italy). The patients were treated three times 
a week, every other day, for a total of 10 sessions. Clinical results were evaluated using visual 
analogic scale for individual pain (0 to 10) and the Oswestry disability scale (ODS). Tests started 
before the beginning of therapies and 8 weeks after the end of the therapies. Visual analogic scale 
(VAS) score significantly improved from an average value of 8.1 ± 1.58 pre-treatment to an average 
value 8-weeks post-treatment of 2.63 ± 2.74 (P < .01). ODS values start from a pre-treatment 
average value of 53.0 ± 13.0 to a post-treatment average value of 23.5 ± 19.8 (P < .01). A higher 
improvement both in VAS and in ODS was denoted in the group of patient with low-back pain and 
leg pain (respectively, VAS from 8.66 ± 1.58 to 2.86 ± 2.94 and ODS from 57.8 ± 15.5 to 
23.7 ± 19.5). Low-back pain, associated or not with leg pain, is a very common clinical situation. 
The treatments of this condition are different, and an important role can be given to 
the laser therapy. The conclusion of this study is that the association between laser therapy 
iLux-Triax® and tecar therapy Pharon® in the treatment of low-back pain, with or without leg 
pain, can significantly reduce pain and improve the quality of life in patients with 
degenerative and inflammatory problems. 
PMID: 25376670 
  
• Effect of diode laser in the treatment of patients with nonspecific chronic low back pain: 
a randomized controlled trial. 
Vallone F, Benedicenti S, Sorrenti E, Schiavetti I, Angiero F. 
Photomed Laser Surg. 2014 Sep;32(9):490-4.  
 
BACKGROUND DATA: Low back pain is a common, highly debilitating condition, whose severity 
is variable. This study evaluated the efficacy of treatment with Ga-Al-As  diode laser (980 nm) with 
a large diameter spot (32 cm(2)), in association with exercise therapy, in reducing pain. 
 
OBJECTIVE: The present study aimed to evaluate the pain reduction efficacy of treatment with the 
Ga-Al-As diode laser (980 nm) in combination with exercise therapy, in patients with 
chronic low back pain (CLBP). 
 
METHODS: This study evaluated 100 patients with CLBP (mean age 60 years) who were randomly 
assigned to two groups. The laser plus exercises group (Laser+EX: 50 patients) received low-
level laser therapy (LLLT) with a diode laser, 980 nm, with a specific handpiece [32 cm(2) 
irradiation spot size, power 20 W in continuous wave (CW), fluence 37.5J/cm(2), total energy per 
point 1200 J] thrice weekly, and followed a daily exercise schedule for 3 weeks (5 days/week). The 
exercises group (EX: 50 patients) received placebo laser therapy plus daily exercises. The 
outcome was evaluated on the visual analogue pain scale (VAS), before and after treatment. 
RESULTS: At the end of the 3 week period, the Laser+EX group showed a significantly 
greater decrease in pain than did the EX group. There was a significant difference between the 

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two groups, with average Δ VAS scores of 3.96 (Laser+EX group) and 2.23 (EX group). The 
Student's t test demonstrated a statistically significant difference between the two groups, at 
p<0.001. 
 
CONCLUSIONS: This study demonstrated that the use of diode laser (980 nm) with large 
diameter spot size, in association with exercise therapy, appears to be effective. Such 
treatment might be considered a valid therapeutic option within rehabilitation programs for 
nonspecific CLBP. 
PMID: 25141218 
  
➢ Short-term therapeutic effects of 890-nanometer light therapy for chronic low back pain: 
a double-blind randomized placebo-controlled study. 
Hsieh RL, Lee WC. 
Lasers Med Sci. 2014 Mar;29(2):671-9.  
 
We conducted a double-blind randomized placebo-controlled study to investigate the effects of 
short-term 890-nm light therapy in patients with chronic low back pain in a rehabilitation clinic. 
Thirty-eight women and 22 men with chronic low back pain (mean age, 60.3 years; range, 32-
80 years) received 40-min sessions of hot-pack therapy combined with active or placebo 890-nm 
light therapy (wavelength = 890 nm, radiant power output = 6.24 W, power density = 34.7 mW/cm(2) 
for 40 min, total energy = 83.2 J/cm(2)) over the lower back three times weekly for 2 weeks. 
Participants were assessed before and after treatment by using a range of motion measurements, 
a visual analog scale evaluation of pain, the Multidimensional Fatigue Inventory, the Biodex Stability 
System, the Fear-Avoidance Beliefs Questionnaire, repeated chair-rising times, the Frenchay 
Activity Index, the Oswestry Disability Questionnaire (ODQ), and the Osteoarthritis Quality of Life 
Questionnaire. The severity of disability based on the ODQ score was used as the primary clinical 
outcome measurement. Compared to the baseline measurements, participants in the treatment 
group reported significant reductions in fear-avoidance beliefs regarding physical activity 
(P = 0.040) and work (P = 0.007) and in the severity of disability (P = 0.021). Treatment with hot-
pack therapy and 890-nm light therapy was associated with reductions in the severity of 
disability and fear avoidance beliefs in patients with chronic low back pain. 
PMID: 23820974 
  
 
• Low level laser therapy for patients with cervical disk hernia. 
Takahashi H, Okuni I, Ushigome N, Harada T, Tsuruoka H, Ohshiro T, Sekiguchi M, Musya Y. 
Laser Ther. 2012 Sep 30;21(3):193-7.  
 
BACKGROUND AND AIMS: In previous studies we have reported the benefits of low level laser 
therapy (LLLT) for chronic shoulder joint pain, elbow, hand and finger pain, and low back pain. The 
present study is a report on the effects of LLLT for chronic neck pain. 
 
MATERIALS AND METHODS: Over a 3 year period, 26 rehabilitation department outpatients with 
chronic neck pain, diagnosed as being caused by cervical disk hernia, underwent treatment applied 
to the painful area with a 1000 mW semi-conductor laser device delivering at 830 nm in continuous 
wave, 20.1 J/cm(2)/point, and three shots were given per session (1 treatment) with twice a week 
for 4 weeks. 
RESULTS: 1. A visual analogue scale (VAS) was used to determine the effects of LLLT for 
chronic pain and after the end of the treatment regimen a significant improvement was observed 
(p<0.001). 2. After treatment, no significant differences in cervical spine range of motion were 

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observed. 3. Discussions with the patients revealed that in order to receive continued benefits from 
treatment, it was important for them to be taught how to avoid postures that would cause them 
neck pain in everyday life. 
 
CONCLUSION: The present study demonstrates that LLLT was an effective form of treatment 
for neck and back pain caused by cervical disk hernia, reinforced by postural training. 
PMID: 24511189 
  
➢ Low power laser in the treatment of the acute low back pain 
Mandić M, Rancié N. 
Vojnosanit Pregl. 2011 Jan;68(1):57-61. 
 
BACKGROUND/AIM: Acute low back pain (ALBP) is one of the most frequent painful conditions in 
the human population. The objective of the paper was to compare the efficacy of the low power 
laser (LPL) in the pain and the muscular spasm reduction with conservative methods of physical 
medicine.  
 
METHOD: The prospective cohort study involved 70 patients, men and women, from 25 to 64 years 
of age with the diagnosis of ALBP. There were two groups: 40 patients in the first group were treated 
with the LPL with frequency of 73 Hz. The second group was the control group, and it consisted of 
30 patients treated with conservative methods of physical medicine (electrotherapy: diadynamic 
currents CP +/- 3 and CP +/- 3, interferent currents--90 Hz for 15 min; electrophoresis with 
novocaine). The ALBP were diagnosed by clinical examination and by nuclear magnetic resonance 
imaging (NMRI). The low power laser--Gallium Arsenide (GaAs) was used. The laser device 
consisted of 4 laser diodes, each powered of 15 mW, wavelength 904 nm and with frequency 73 
Hz. The total period of time for each treatment was 10 minutes and the total dose per treatment 
was 15 J. The intensity of acute low back pain was assessed by Roland's scale. The degree of the 
spasm was assessed in the relaxed position and during movements.  
 
RESULTS: The average score in the first group before the onset of rehabilitation was 3.3 +/- 1.1 
(Me = 3.0), and in the control group, it was 3.43 +/- 0.89 (Me = 3.0). After five treatments, in patients 
who were treated with LPL, the average Roland's scale score decreased (1.12 +/- 1.3, Me = 2.0) 
while there was no change for scores in the control group. After 10 treatments with the LPL, the 
analgesic effect was obtained in 82.5% of patients from the test group and in 20% of patients in the 
control group. The analgesic effect in patients of the test group was obtained after 7.5 +/- 2.1 
treatments and in the second group after 17.9 +/- 3.2 treatments. The difference was statistically 
significant (t = 15.652173, p < 0.001). The spasm disappeared in 92.5% of patients in the test group 
and in 20% of patients in the control group after 7.02 +/- 2.2 and 17.9 +/- 3.2 treatments respectively. 
The difference was statistically significant (t = 15.652173, p < 0.001). 
 
CONCLUSION: Pain and spasm reduction were obtained in the greater number of patients 
by usage of the LPL than by usage of conservative methods of physical medicine. 
 
 

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➢ Efficacy of low power laser therapy and exercise on pain and functions in chronic low 
back pain 
Gur A, Karakoc M, Cevik R, Nas K, Sarac AJ, Karakoc M. 
Lasers Surg Med. 2003;32(3):233-8. 
 
BACKGROUND AND OBJECTIVES: The aim of this study was to determine whether low power 
laser therapy (Gallium-Arsenide) is useful or not for the therapy of chronic low back pain (LBP). 
 
STUDY DESIGN/MATERIALS AND METHODS: This study included 75 patients (laser + exercise-
25, laser alone-25, and exercise alone-25) with LBP. Visual analogue scale (VAS), Schober test, 
flexion and lateral flexion measures, Roland Disability Questionnaire (RDQ) and Modified Oswestry 
Disability Questionnaire (MODQ) were used in the clinical and functional evaluations pre and post 
therapeutically. A physician, who was not aware of the therapy undertaken, evaluated the patients. 
 
RESULTS: Significant improvements were noted in all groups with respect to all outcome 
parameters, except lateral flexion (P < 0.05). 
 
CONCLUSIONS: Low power laser therapy seemed to be an effective method in reducing pain 
and functional disability in the therapy of chronic LBP. 
 
➢ In chronic low back pain, low level laser therapy combined with exercise is more 
beneficial than exercise alone in the long term: a randomized trial. 
Djavid GE, Mehrdad R, Ghasemi M, Hasan-Zadeh H, Sotoodeh-Manesh A, Pouryaghoub G. 
Aust J Physiother. 2007;53(3):155-60. 
 
QUESTION: Is low level laser therapy an effective adjuvant intervention for chronic low back pain. 
 
DESIGN: Randomized trial with concealed allocation, blinded assessors and intent-to-treat 
analysis. 
 
PARTICIPANTS: Sixty-one patients who had low back pain for at least 12 weeks. 
 
INTERVENTION: One group received laser therapy alone, one received laser therapy and exercise, 
and the third group received placebo laser therapy and exercise. Laser therapy was performed 
twice a week for 6 weeks. 
 
OUTCOME MEASURES: Outcomes were pain severity measured using a 10-cm VAS, lumbar 
range of motion measured by the Schober Test and maximum active flexion, extension and lateral 
flexion, and disability measured with the Oswestry Disability Index on admission to the study, after 
6 weeks of intervention, and after another 6 weeks of no intervention. 
 
RESULTS: In the laser therapy + exercise group, pain decreased by 1.8 cm (95% CI 0.1 to 3.3, p 
= 0.03), lumbar range of movement increased by 0.9 cm (95% CI 0.2 to 1.8, p < 0.01) on the 
Schober Test and by 15 deg (95% CI 5 to 25, p < 0.01) of active flexion, and disability reduced by 
9.4 points (95% CI 2.7 to 16.0, p = 0.03) more than in the exercise group at 12 weeks. 
 
CONCLUSION: In chronic low back pain low level laser therapy combined with exercise is 
more beneficial than exercise alone in the long term. 
 
 

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➢ Acute Low Back Pain with Radiculopathy: A Double-Blind, Randomized, Placebo-
Controlled Study.   
Konstantinovic LM, Kanjuh ZM, Milovanovic AN, Cutovic MR, Djurovic AG, Savic VG, Dragin AS, 
Milovanovic ND. 
Photomed Laser Surg.  
 
OBJECTIVE: The aim of this study was to investigate the clinical effects of low-level laser therapy 
(LLLT) in patients with acute low back pain (LBP) with radiculopathy. 
 
BACKGROUND DATA: Acute LBP with radiculopathy is associated with pain and disability and the 
important pathogenic role of inflammation. LLLT has shown significant anti-inflammatory effects in 
many studies.  
 
MATERIALS & METHODS: A randomized, double-blind, placebo-controlled trial was performed on 
546 patients. Group A (182 patients) was treated with nimesulide 200 mg/day and additionally with 
active LLLT; group B (182 patients) was treated only with nimesulide; and group C (182 patients) 
was treated with nimesulide and placebo LLLT. LLLT was applied behind the involved spine 
segment using a stationary skin-contact method. Patients were treated 5 times weekly, for a total 
of 15 treatments, with the following parameters: wavelength 904 nm; frequency 5000 Hz; 100-mW 
average diode power; power density of 20 mW/cm(2) and dose of 3 J/cm(2); treatment time 150 
sec at whole doses of 12 J/cm(2). The outcomes were pain intensity measured with a visual analog 
scale (VAS); lumbar movement, with a modified Schober test; pain disability, with Oswestry 
disability score; and quality of life, with a 12-item short-form health survey questionnaire (SF-12). 
Subjects were evaluated before and after treatment. Statistical analyses were done with SPSS 
11.5.  
 
RESULTS: Statistically significant differences were found in all outcomes measured (p < 0.001), 
but were larger in group A than in B (p < 0.0005) and C (p < 0.0005). The results in group C were 
better than in group B (p < 0.0005). Conclusions: The results of this study show better 
improvement in acute LBP treated with LLLT used as additional therapy. 
 
➢ Promising results of Laser for Low Back Pain pilot study presented at ACBSP meeting 
in Chicago Class IV Laser Therapy; Effective for Back and Neck/Shoulder Pain 
June 25, 2010 
 
BACKGROUND: Class IV laser therapy is a recent modality used to treat pain and promote healing 
of muscular tissue. The procedure is minimally invasive and easily performed. Laser therapy was 
added to conventional chiropractic treatment of spinal manipulation and an exercise program for 
treating patients with back pain. The objective of this investigation was to assess efficacy and safety 
of the combination and generate preliminary results for a randomized controlled trial. 
 
METHODS: Between 9/2009 and 2/2010, a total of 55 patients with non-surgical lower back pain 
(sciatica) presented to my office and gave consent for treatment. Twenty-four patients with back 
pain received spinal Class IV laser therapy in addition to manipulation for back pain. Twenty-one 
patients (historical controls) received spinal manipulation without Class IV laser therapy. All patients 
completed VAS scales before treatment (VAS0), at one week (VAS1), and at four weeks (VAS4). 
Regardless of treatment group, all patients received a personalized regimen of spinal manipulation, 
manual therapy, and exercise, under the direction of the principal investigator (LDM). Percent 
difference between VAS0 and VAS4 was compared between groups. 
 

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RESULTS: Demographics were similar for both groups (Table 1). Patients in the manipulation + 
laser group reported pain relief after 2-3 sessions of laser therapy (clinical observation). No adverse 
events were noted following laser therapy. 
 
A positive-valued percent differences of VAS between pretreatment and 4wk points; indicate that a 
quantitative reduction in pain by both treatment groups. Statistical comparison of the groups using 
an unpaired t-test indicated that the manipulation + laser offers greater pain reduction when 
compared to manipulation only (p=0.007). Interval estimates indicate a 21.18 larger reduction in 
VAS (95% Confidence Interval: 6.00, 36.35) in the manipulation + laser group. 
 
Conclusions: These results indicate that both treatments successfully reduced the VAS by the 
fourth week of treatment, and that a higher reduction in VAS occurred in the group treated by 
manipulation + laser at week four. 
 
In summary, Class IV laser therapy is a safe and effective modality for treating low back pain 
when added to conventional treatment of manipulation and exercise.  
➢ Experiences of Acupuncture in the Treatment of Chronic Low Back Pain. Kertesz Agnes, 
Hegyi Gabriella. Albert Szent-Gyorgyi Medical University, Szeged, Hungary 
INTRODUCTION: Conventional and complimentary medicine offer numerous possibilities for 
reduction or elimination of chronic pain. In a large majority of cases, conventional therapy affords a 
satisfactory result. In a significant number of subjects however, the improvement is not appropriate. 
The present work has the aim of demonstrating the opportunities provided by one of the main 
branches of complimentary medicine, acupuncture. This report summarizes the results attained by 
treating chronic low back pain by means of laser-therapy. METHODS: 90 patients with chronic pain 
in the low back took part in the study. They received laser-acupuncture treatment administrated to 
acupuncture points in the ear and in the body that corresponded to the principles of traditional 
Chinese medicine. The instrumental parameters, applied: Seirin laser pen Ga A, As diode, 780nm 
laser category 3B, 5mW, 10Hz. RESULTS and CONCLUSIONS: Prior to the acupuncture 
treatment, these 90 patients had participated in conventional therapy without any essential 
improvement. In response to 3-5 laser-acupuncture therapy sessions, complete remission of 
pain was achieved in 72 cases. In patients who exhibited only a temporary improvement even 
after the fifth session, CT and MRI recordings confirmed the suspicion on discus hernia, and these 
patients underwent surgery. Even after a period of 3 years, the 72 patients have not observed 
recurrence of the pain. These results demonstrate that lasting freedom from pain can be attained 
in cases, which do not respond to conventional therapy. At the same time, it draws attention to the 
necessity of the application of modern imaging procedures in order to make an accurate diagnosis 
in those subjects who do not improve satisfactorily.” 
 
 

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➢ Low energy laser in the treatment of low back pain. S. Nikolic, Z. Trojacanec, I.J. Milankovic 
Address Institute of ME Physiology, Faculty of Medicine, Skopje, F.Y.R.O.M  
“The aim of the study was to explore the pain-alleviating effect of low energy laser in low back 
pain.Thirty-five patients with low back pain have been treated with helium-neon laser type "Bistra" 
with wavelength 630 nm, average output 15 mW and an irradiance of 250 mW/cm2. The laser was 
locally applied to 11 sites on and around the low back. After scanning, each point was treated for 
30 seconds, five times weekly for a total of ten treatments. The statistical analysis showed that the 
laser treated patients had a significant faster pain-alleviating effect compared with the 30 patients 
treated with medicaments only. Subjective responses have been achieved after the first three 
treatments. Irradia laser treatment may be a valuable therapy in low back pain and low energy 
laser can be employed as a pain relieving method.”  
➢ Low Energy Laser Therapy with Trigger Points Technique 
Z. Simunovic, 
American Society for Laser Medicine and Surgery Abstracts 
 
"There are also very promising 'trigger points", i.e. myofacial zones of particular sensibility and of 
highest projection of pain focal points, due to ischaemic conditions. The effect of LLLT and the 
results obtained after clinical treatment of more than 200 patients (headaches, facial pain, skeletal 
muscular ailments, myogenic neck pain, shoulder arm pain, epicondylitis humary, tenosynovitis, 
low back and radicular pain, Achilles tendonitis) to whom "trigger points" were applied turned out 
to be better than we have ever expected. According to clinical parameters, it has been observed 
that the rigidity decreases, the mobility is restored and that also the spontaneous or induced pain 
decreases or even disappears. LLLT improves microcirculation and it can also improve oxygen 
supply. Results measured according to VAS/VRS/PTM: acute pain diminished by 72% and 
chronic pain by 66%.” 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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STUDY DESIGN 
 
This clinical study is a double-blind, placebo-controlled randomized parallel group design multi-site 
evaluation of the effect of the Erchonia® FX-635™ on providing temporary relief of minor episodic 
chronic low back pain of musculoskeletal origin. 
 
SUBJECT GROUPS  
 
Each subject will be randomized to the test procedure group or to the placebo procedure group, as 
follows: 
 
Test procedure group: Subjects randomized to the test procedure group will receive the study 
procedures with the active (true) Erchonia® FX-635™ laser.  
 
Control procedure group: Subjects randomized to the control procedure group will receive the study 
procedures with a ‘fake’ (placebo) Erchonia® FX-635™ laser.   
 
The ‘fake’ (placebo) laser device will appear to the subject to be an active device, but will not 
produce any therapeutic light output. The placebo laser device is designed to have the same 
physical appearance as the actual (active test) laser device, including the appearance of any visible 
light output. Therefore, both the test and control devices emit light when activated that is 
indistinguishable to the subject. As the laser light does not put out any notable degree of heat or 
noise, these are not distinguishing factors for subjects between the active and control devices.  
 
Apart from the distinction of whether or not the subject receives the study procedures with the actual 
or the fake laser device, all subjects and investigative parties will adhere to all phases of the entire 
protocol design.   
 
DOUBLE BLIND DESIGN  
This clinical study will be a double-blind design, such that neither the subject nor the investigator 
will be aware of whether a subject is receiving the study treatments with the active (test procedure 
group assignment) or the ‘fake’ (placebo procedure group assignment) Erchonia® FX-635™ until 
after the study is completed.  
 
Maintenance of study double-blind throughout the entire course of the study will be achieved 
through the following means: 
 
1) Each subject will be randomly assigned to Procedure Group A or to Procedure Group B by the 
independent study Monitor. Subjects assigned to Procedure Group A will be treated with the 
Erchonia® FX-635™ A and subjects assigned to Procedure Group B will be treated with 
Erchonia® FX-635™ B. Only the study Sponsor will know which label (‘A’ or ‘B’) corresponds 
to the actual (test) FX-635™ device and which label corresponds to the ‘fake’ device until the 
final study data analysis is complete. The Sponsor will ensure that this information is stored and 
maintained confidentially at the Sponsor’s work site. This knowledge will not be shared with the 
investigators, the subjects, or the study Monitor until the final data analysis is complete. 
 
2) The fake (placebo) Erchonia® FX-635™ is designed to have the same physical appearance as 
the actual Erchonia® FX-635™, including the appearance of any visible light output. Therefore, 
both the test and sham devices emit light when activated that is indistinguishable to both the 
subject and to the investigator. As the laser light does not put out any notable degree of heat or 
noise, these are not distinguishing factors for subjects between the two groups.  
 

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3) There will be two independent investigators interacting with subjects:  
 
(i) Administration Investigator: who will be responsible for administrating the study treatments 
to the subject; and 
(ii) Assessment Investigator: who will be responsible for recording the study outcome 
measures. Only the administration investigator will be aware of whether a subject is 
assigned to Procedure Group A or B, although he or she will not be made aware of whether 
A or B corresponds to the true or fake laser. Neither the assessment investigator nor the 
subject will be aware of the subject’s A/B Group assignment. In this way, the assessment 
investigator will not be able to form an association between A/B Procedure Group and 
active/sham device over the course of the study if a treatment effect is observed. 
 
4) During the laser procedures, both the subject and the administration investigator will wear NiOR 
LaserShields® MLA glasses that filter out the laser light spectrum. 
 
RANDOMIZATION 
 
Subject allocation to procedure group will be via variable block randomization with varying block 
sizes of two, four and six used at random to minimize the likelihood of predicting the next procedure 
group assignment. In addition, randomization will be stratified by test site. 
 
Randomization will be attained using computer generation sequence methodology, insuring that 
the randomization methodology and the generated allocation sequence is concealed from the 
investigator and subjects.  
 
Concealment will be insured as follows: 
 
(ii) Each computer-generated randomization sequence is unique and will therefore not be able to 
be replicated. 
(iii) Randomization will occur to either ‘Procedure Group A’ or to ‘Procedure Group B’ rather than 
to a test or placebo group, and only the study Sponsor will know which assignment (A or B) 
corresponds to the active device and which corresponds to the fake device. The Sponsor will 
not reveal this information to any source (investigators, subjects, or study Monitor) until the final 
study data analysis is complete. 
 
Once a subject has qualified for and been enrolled in the study, the Principal Investigator will contact 
the study Monitor who will act as the central source for providing sequential subject procedure group 
assignment.  
 
SUBJECTS  
 
Recruitment 
Subjects will be recruited from among the Principal Investigator’s/test site’s pool of patients who are 
currently being treated for, or who are seeking treatment for, diagnosed minor episodic chronic low 
back pain of musculoskeletal origin, or from response to the following recruitment materials.   
 
 
 
 
 
 
 

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a) Flyer 
 
 
WANTED 
 
ADULTS WITH LOW BACK PAIN ONGOING  
OVER THE LAST 3 MONTHS FOR A  
CLINICAL STUDY OF THE EFFECTS OF  
LOW LEVEL LASER LIGHT ON  
REDUCING LOW BACK PAIN  
 
 
THIS STUDY INVOLVES EIGHT  
LASER LIGHT PROCEDURES  
WITH THE ERCHONIA® FX-635™ LASER  
OVER 4 WEEKS AT THE TEST SITE.  
 
THERE ARE TWO MORE VISITS TO THE TEST SITE   
ONE MONTH AND TWO MONTHS AFTER  
THE LAST LASER LIGHT PROCEDURE. 
 
COMPENSATION OF $300  
FOR QUALIFIED PARTICIPANTS 
 
FOR MORE INFORMATION PLEASE CONTACT: 
 
<PI name> 
<test site name & location> 
<phone # and/or e-mail> 
 

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b) Newspaper Ad 
Low Back Pain 
Research Study 
 
This study is to see if the Erchonia® 
FX-635™, a non-invasive, 
investigational device that uses low-
level laser light, can help to relieve 
minor low back pain that has been 
ongoing for at least 3 months. 
 
The study involves eleven visits to  
a test site and recording some 
information at home. 
 
Compensation up to $300 
For qualified participants 
 
Please contact <PI name> at 
<test site name & location> at  
<phone and/or e-mail> for details. 
 
Compensation  
A subject who completes his or her participation in this clinical study through to the final post-
procedure administration visit will receive financial compensation of $300. 
 
A subject will not be charged for the cost of the study procedures with the Erchonia® FX-635™ 
Laser or for the cost of any other directly-related evaluations or measurements that occur as part 
of his or her participation in the study.  
 
Sample size  
There will be 64 qualified subjects enrolled in this clinical study: 
• 32 subjects in the active procedure group 
• 32 subjects in the control procedure group 
 
 
 

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Rationale for sample size 
In the determination of sample size, the following parameters have been established for the 
purposes of assessing efficacy of the Erchonia® FX-635™ in this clinical study: 
 
➢ Individual subject success criteria defined as a 30% or greater reduction in self-reported Degree 
of Pain rating on the 0-100 VAS from baseline to study endpoint evaluation.  
➢ Overall study success criteria defined as a minimum 35% difference between the test device 
group and the placebo device group in the proportion of individual successes.  
➢ It is anticipated that about 55% of subjects in the test device group and about 20% of subjects 
in the placebo device group will meet the individual success criteria, and 
➢ Intended application of a two-tailed test with an alpha value of 0.05 and Power of 0.8 
 
The clinical relevance of a 30% change in VAS score and a 35% difference in the proportion of 
individual successes between procedure groups has been well previously established over the past 
8 years by FDA’s Division of Surgical, Orthopedic and Restorative Devices through numerous pre-
IDE reviews, the results of said studies that were subsequently used to successfully support various 
pain-reduction related indications for various Erchonia Corporation light therapy devices under 
Product Code NHN for the 510(k)s as listed below: 
 
1. K101430; 06/22/10: “The FX-635™-AC DermaScanner™ is indicated, while using the red 
diodes, for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain 
of musculoskeletal origin.” 
2. K100509; 06/08/10: “The Erchonia THL1 is indicated for use in providing temporary relief of 
minor chronic neck and shoulder pain of musculoskeletal origin.” 
3. K072206; 04/24/08: “The Erchonia EML Laser is indicated for the temporary reduction in post -
surgery pain at 24 hours after surgery following breast augmentation surgery.” 
4. K050672; 06/02/05: “The Erchonia EVRL Laser is generally indicated while using the red diode 
for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of 
musculoskeletal origin.” 
5. K041139; 09/30/04: “The Erchonia EML Laser is indicated as an adjunct to liposuction 
procedures of the thighs, hips and stomach for reduction of pain associated with the recovery 
process.” 
 
In consideration of the above parameters established for the purposes of sample size calculation, 
the sample size of 29 subjects per procedure group (test group and placebo group, separately) has 
been determined using the following reference calculator: Hypothesis Testing: Categorical Data - 
Estimation of Sample Size and Power for Comparing Two Binomial Proportions in Bernard Rosner's 
Fundamentals of Biostatistics. 
 
It is anticipated that about one-twentieth of subjects overall may withdraw from the study prior to 
completion for various reasons. Therefore, the following formula is used to determine the final 
needed starting sample size for each group: 
 
Final sample size = sample size X 1/(1-d); where d = # expected dropouts/# subjects enrolled. 
Final sample size = 29 X 1/(1-0.083) 
Final sample size = 29 X 1/0.917 = 29 X 1.0905 = 31.62, rounded to 32 subjects per group. 
 
Therefore, a minimum starting sample size of 32 subjects in each procedure group is needed to 
ensure that a sufficient number remains at the end of the trial (29 subjects per group) for any 
significant differences found between groups to be considered statistically valid and representative 
of the general population being sampled. This results in a total of 64 subjects being enrolled in this 
study across both study procedure groups.  

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STUDY PROCEDURE 
 
          STUDY TEST BATTERY 
 
The following is a listing and description of the study measurement and assessment tools to be 
used and the variables to be recorded in this clinical study. At each evaluation point, the precise 
tools and variables from this list that will be employed will be specified.  
 
 
QUALIFICATION EVALUATION TOOLS 
 
THE SIMPLIFIED CALCULATED OSTEOPOROSIS RISK ESTIMATION (SCORE) 
 
The Simplified Calculated Osteoporosis Risk Estimation (SCORE) questionnaire, developed by 
Lydick et al., is a screening tool used to determine if a woman should be evaluated for osteoporosis 
by bone densitometry. 
 
SCORE performed well when compared to other prediction rules. Performance characteristics for 
SCORE are: 
 
T-score 
Sensitivity 
Specificity 
< -2 
98% 
28% 
< -1 
91% 
31% 
 
SCORE is comprised of the following 6 questions: 
 
(1) age  
(2) race  
(3) body weight in pounds  
(4) history of rheumatoid arthritis  
(5) history of estrogen therapy  
(6) types of nontraumatic fractures after the age of 45 
 
Scoring and Total SCORE calculation is as follows: 

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where  
• The fracture types are wrist rib and hip; the maximum number is 3.  
simplified calculated osteoporosis risk estimation (SCORE) =  
= SUM (points for the 6 questions) 
 
Interpretation of SUM SCORE:  
 
• Threshold value: 6  
• If SCORE > 6 then bone densitometry evaluation should be conducted.  
 
References: Lydick E Cook K et al. Development and validation of a simple questionnaire to 
facilitate identification of women likely to have low bone density. Am J Managed Care. 1998; 4: 37-
48. 
 
 
DUAL-ENERGY X-RAY ABSORPTIOMETRY (DEXA) 
 
DEXA is the most accurate means of bone mineral density measurement.  A bone density test 
measures the density of minerals (such as calcium) in the bones using a special X-ray, the results 
of which are used to estimate bone strength. DEXA uses two different X-ray beams to estimate 
bone density in the spine and hip.  Strong, dense bones allow less of the X-ray beam to pass 
through them. The amounts of each X-ray beam that are blocked by bone and soft tissue are 
compared to each other. DEXA can measure as little as 2% of bone loss per year. It is fast and 
uses very low doses of radiation.  

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DEXA assessment generates a T-score which represent the individual’s bone density compared 
with the norm for other healthy young adults of the same gender.  The T-score is the number of 
units, or standard deviations, that the individual’s bone density is above or below the average. 
 
T-score ranges and associated interpretations is shown below. 
 
T-score 
Interpretation 
-1 and above 
Normal bone density. 
Between -1 and -2.5 
A sign of osteopenia, a condition in which bone density is 
below normal and may lead to osteoporosis. 
-2.5 and below 
Indicative of likely osteoporosis. 
 
 
The World Health Organization (WHO) criteria will be applied in this study, such that a DEXA T-
score of ≤2.5 will be considered likely to have osteoporosis.  
 
BASELINE VARIABLES 
 
BASELINE LOW BACK PAIN VARIABLES: The following is recorded at baseline evaluation: 
(i) Location of low back pain: right side only; left side only; across all lower back  
(ii) Duration of low back pain: months/years since onset of first episode 
 
PRIOR TREATMENT APPROACHES: Any and all prior treatments that the subject has tried to 
manage his or her low back pain and associated symptoms (such as reduced ROM), including: 
(i) 
Over-the-counter (OTC) medications 
(ii) Prescription medications 
(iii) Traditional therapies such as physical therapy, occupational therapy  
(iv) Alternative therapies such as herbal supplements, chiropractic manipulation, acupuncture, 
massage    
 
Noting, for each medication/therapy tried: 
(i) 
Date(s) of use/application 
(ii) Duration of use/application 
(iii) Perceived effectiveness 
 
 
BASELINE CONCOMITANT MEDICATION AND THERAPY USE: The following is recorded at 
baseline evaluation:     
 
(i) Over-the-counter and prescription medications currently used by the subject specifically to 
relieve his or her low back pain, including dosage and typical frequency of use information.   
(ii) Non-drug treatments/therapies (conventional, alternative and experimental) currently used by 
the subject specifically to relieve his or her low back pain, including information on frequency or 
duration of use and other pertinent application information.   
(iii) Over-the-counter and prescription medications currently used, and therapies currently engaged 
in by the subject for any non-pain relief indication, including dosages and frequency/duration of 
use. 

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SUBJECT DEMOGRAPHICS: The subject’s age, gender and ethnicity are recorded. 
 
RESCUE PAIN MEDICATION USE 
 
For the purpose of standardization and comparability of outcome assessment across the study 
subject population, this clinical study will incorporate the use of rescue pain medication for subject 
as-needed management of low back pain throughout study participation duration. 
 
The rescue pain medication to be used in this study will be over-the-counter Regular Strength 
Tylenol® tablets. Each subject will be instructed to take a dosage of Tylenol as needed to control 
any low back pain he or she may be experiencing, ensuring that the directions for use on the labeling 
are followed.  
 
The subject will be instructed to record in the Subject Daily Diary each time he or she takes a dose 
of the study rescue pain medication at any time during the entire course of his or her study 
participation from study enrollment through to the final post-procedure administration visit. 
 
The subject will be instructed to not take a dose of any other over-the-counter or prescription 
medications for the indication of pain relief, including NSAIDs other than the specified study rescue 
pain medication, across the entire course of his or her study participation from study enrollment 
through 
to 
the 
final 
post-procedure 
administration 
visit. 
 
The subject will be instructed not to record a VAS pain rating (whenever indicated) any sooner than 
six hours after taking a dosage of the study pain relief rescue medication to ensure that the effect 
of the pain relief rescue medication does not influence the recorded effect of the study procedures 
with the Erchonia® FX-635™ device. That is, a VAS rating is only to be recorded once the effect of 
any previously-consumed rescue pain medication has dissipated. The subject will be able to take 
another dosage of the study pain relief rescue medication immediately after recording the VAS 
rating, if needed to manage his or her low back pain.  
 
Throughout the course of his or her study participation, a subject can continue to take any other 
over-the-counter and/or prescription medication(s) that he or she usually takes for any other (non-
pain relief) indication(s), as he or she usually takes them, as reported at Baseline evaluation and 
approved by the study investigator. Subjects will be required to record each time he or she takes a 
dose of any non-pain relief indicated medication in the Subject Daily Diary across study participation 
duration.   
 
OUTCOME ASSESSMENT TOOLS 
 
VISUAL ANALOG SCALE (VAS) DEGREE OF PAIN RATING 
 
Subjects will be asked to rate the overall degree of pain experienced in the lower back region on 
the following 0-100 mm (0 -10 cm) Visual Analog Pain Scale, by responding to the following 
question: 
 
“Using the scale below, please mark with a cross (X) the spot along the 0 to 100 line below that 
best shows how much pain you feel in your lower back right now. ‘0’ means you feel no pain at 
all and ‘100’ means you feel the worst pain imaginable. Please mark only one spot.”   
 
                     no pain  
                                              worst pain imaginable 
 
 

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The Visual Analog Pain Scale (VAS) is one of the three most commonly used scales for assessing 
chronic pain. It is a simple scale that consists of a line anchored at one end by a label such as "NO 
PAIN" and at the other end "WORST POSSIBLE PAIN". The subject marks on the line the spot for 
the pain intensity, which is then measured.  
 
Standard guidelines for effective use of the VAS that are followed in this clinical study are: 
 
i. The line should be 10, 15 or 20cm long, as other lengths are less reliable.  
ii. There should be a small vertical mark at each end, with numbers 0 and 100, and a verbal 
description.  
iii. The verbal description must be in absolute terms (e.g. worst pain imaginable); 
iv. The line itself should be clear of any markings and should be horizontal rather than vertical, for 
more reliable measurements.  
 
Used in the above way, it has been shown that the VAS is a proper ratio scale. Like a thermometer, 
this means that its two ends are rooted, and a doubling of the score does accurately reflect a 
doubling of the pain. Consequently, sensitive t-tests and ANOVA methods can be used in the 
analysis, so that significant differences can be identified with relatively small sample sizes or small 
differences between groups.  
Source: Measuring Pain by Adrian White, Acupuncture in Medicine, November 1998 – Vol 16 No. 2 
 
The subject is instructed to refrain from consuming any pain relief medication within 6 hours of 
recording a required VAS Degree of Pain Rating to ensure that the effect of the pain relief 
medication does not influence any potential treatment effect of the study procedure with the 
Erchonia® FX-635™ evidenced through the VAS ratings. The subject may take a dosage of his or 
her study rescue pain relief medication immediately after recording a VAS rating, if needed.  
 
THE OSWESTRY DISABILITY INDEX (ODI)/OSWESTRY LOW BACK PAIN QUESTIONNAIRE  
 
The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain 
Questionnaire used by clinicians and researchers to quantify disability for acute or chronic low back 
pain. The ODI is currently considered the gold standard of low back functional outcome tools for 
measuring degree of disability and estimating quality of life in a person with low back pain.  
 
The validated questionnaire was first published by Jeremy Fairbank et al. in Physiotherapy in 1980. 
The current version was published in the journal Spine in 2000. The self-completed questionnaire 
evaluates the patient’s perceived level of disability in 10 everyday activities of daily living concerning 
intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability 
to stand, social life, sleep quality, and ability to travel.  
 
Each topic category is followed by 6 statements describing different potential scenarios in the 
patient's life relating to the topic. The patient then checks the statement which most closely 
resembles their situation.  
 
Scoring  
Each question is scored on a scale of 0-5, with the first statement being zero and indicating the 
least amount of disability and the last statement scored 5 indicating most severe disability. If more 
than one box is marked in each section, the highest score is used to calculate the ODI. 
 
The ODI is expressed as a percentage and calculated by dividing the summed score of each 
question answered by the total possible score (that is dependent on how many questions are 
answered) and multiplying by 100.  

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Zero is equated with no disability and 100 is the maximum disability possible. 
 
Minimum detectable change (90% confidence) is 10% points  
 
Scoring Interpretation 
 0 to 20: minimal disability 
• 21-40: moderate disability 
• 41-60: severe disability 
• 61-80: crippling back pain 
• 81-100: these patients are either bed-bound or have an exaggeration of their symptoms.  
 
References 
• Fairbank J, Couper J, Davies J, O'Brian J. The Oswestry low backpain questionnaire, 
Physiotherapy 1980; 66:271-3. (Version 1.0) 
• Fairbank J, Pynsent P. The Oswestry disablility index. Spine 2000;25: 2490-53. (Version 2.0) 
• Roland M, Fairbank J. The Roland-Morris Disability Questionnaire and the Oswestry Disability 
Questionnaire. Spine 2000;25:3115-3124 (Version 2.1) 
 
The Oswestry Low Back Pain Questionnaire is contained in Appendix D. 
 
RANGE OF MOTION (ROM) 
 
The subject’s ROM measurements for flexion, extension, left lateral flexion and right lateral flexion 
will be taken using a goniometer and following the American Medical Association Guides (2nd and 
4th editions) recommendation using measurements of thoracolumbar and lumbar range of 
movement, respectively, to estimate the percentage of impairment in patients with chronic low back 
pain. These measurements evaluate the mobility of the lumbar spine from both an articular and a 
muscular standpoint.  
 
The table below shows the normal measurement values in degrees for each ROM location. 
  
Measurement 
Normal 
Flexion 
60 degs. 
Extension 
25 degs. 
Left Lateral Flexion 
25 degs. 
Right Lateral Flexion 
25 degs. 
 
 
SUBJECT DAILY DIARY 
 
Throughout the duration of a subject’s participation in this clinical study, from study entry through 
to the final post-procedure administration visit, inclusive, the subject is required to maintain a 
Subject Daily Diary. On each day of the study, the subject will record the following information in 
the Subject Daily Diary, as is applicable:  
 
✓ Rescue Pain Medication Use: The subject will record each time a dose of the study rescue 
pain medication is taken as needed to manage low back pain. 
✓ Other Pain Medication Use: The subject will record each time a dose of pain medication other 
than the study rescue pain medication is taken to manage low back pain. The subject, will, 

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however, have been instructed to take only the study rescue medication for low back pain relief 
during the duration of study participation, but deviations are to be recorded. 
✓ Other Pain Management Use: The subject will record each time any treatment, therapy or 
other means of low back management that is not an OTC or a prescription medication is applied 
to manage his or her low back pain. The subject, will, however, have been instructed to not 
engage in any other therapeutic applications for low back pain relief other than the study rescue 
medication for low back pain relief during the duration of study participation, but deviations are 
to be recorded. 
✓ Other Non-Pain Relief Medication and Therapy Use: The subject will record each time any 
OTC or prescription medication is taken and/or any treatment or therapy is applied for any 
indication other than to relieve low back pain. These medications and treatments/ therapies will 
be recorded independent of whether or not it was report as a concomitant medication.tt/therapy 
at baseline evaluation.    
✓ Adverse Events recording: The subject will record each day whether or not he or she believes 
an adverse event was experienced that day. The subject will be instructed as to potential 
adverse events from the laser applications as well as how to identify a potential adverse event 
in general. The subject will be instructed to contact the study investigator right away if he or she 
believes an adverse event may have occurred for immediate evaluation.     
 
SUBJECT SATISFACTION WITH STUDY OUTCOME 
 
The subject is asked to rate how satisfied he or she is with any change in low back pain following 
completion of the laser administration procedures with the Erchonia® FX-635™ by using the 5-
point Likert scale presented below to respond to the following question: “Overall, how satisfied or 
dissatisfied are you with any change in the pain in your lower back following the study procedures 
with the study laser device?”  
 
• Very Satisfied 
• Somewhat Satisfied 
• Neither Satisfied nor Dissatisfied 
• Not Very Satisfied 
• Not at All Satisfied   
 
BLINDING EFFICACY EVALUATION TOOLS 
 
SUBJECT PERCEIVED GROUP ALLOCATION AND RATIONALE 
 
The subject records whether he or she believes to have received the study procedures with the true 
or fake Erchonia® FX-635™ and records verbatim his or her reasoning or rationale for this 
perceived determination. 
 
ASSESSMENT INVESTIGATOR PERCEIVED SUBJECT GROUP ALLOCATION AND 
RATIONALE 
 
The Assessment Investigator records whether he or she believes the subject to have received the 
study procedures with the true or fake Erchonia® FX-635™ and records verbatim his or her 
reasoning or rationale for this perceived determination. 

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STUDY PROCEDURE PROTOCOL 
 
PRE-PROCEDURE ACTIVITIES 
 
The pre-procedure activities will be conducted at the test site prior to administration of the initial 
study procedure with the Erchonia® FX-635™. 
 
STUDY QUALIFICATION 
 
SIGNING OF INFORMED CONSENT FORM 
The PI will commence by presenting and reviewing in detail the items in the informed consent form 
with the individual and answer any questions he or she may have. To proceed, the individual must 
willingly sign the informed consent form. 
 
ASSIGNMENT OF SUBJECT IDENTIFICATION NUMBER 
The subject will be assigned a unique subject identification number based upon his or her order of 
entry into the study. 
 
Additional information about the informed consent and subject ID number assignment is contained 
in a later section of the protocol titled, “SAFETY AND CONFIDENTIALITY ISSUES.” 
 
STUDY QUALIFICATION EVALUATION: INCLUSION/EXCLUSION CRITERIA  
 
INCLUSION CRITERIA 
 
To be eligible for study participation, a subject must satisfy each of the following criteria. 
 
➢ The subject’s presenting primary pain must be located in the region of the lower back, right 
and/or left side(s), with the ‘lower back’ region defined as the area between the boundaries of 
the lowest rib and the crease of the buttocks  
➢ Subject’s low back pain is of musculoskeletal origin, defined as low back pain stemming from 
benign musculoskeletal problems wherein the etiology is lumbar sprain or strain - a stretch injury 
to the ligaments, tendons, and/or muscles of the low back - that occurs in the absence of any 
serious underlying pathology or nerve root compromise 
 
Diagnosis is based on the following subject profile information: 
 
a) Patient History:  
(i) Initial onset of low back pain occurred after one or more of the following: 
 
✓ known injury, such as an accident or fall 
✓ overexertion of a muscle, such as after unusual amounts of exercise or unaccustomed 
activity, or sustained positioning (typically indicative of a strain injury)  
✓ sudden force or movement exerted upon ligaments, such as unusual turning or twisting 
(typically indicative of a sprain injury) 
 
(ii)  At least two of the following five are reported: 
 
✓ Complaints of pain and/or loss of function such as inability to turn, twist or bend normally 
✓ Pain located along lower back and upper buttocks; may radiate into surrounding tissue 
✓ Pain worsens with activity 

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✓ Painful muscle spasms that can worsen with activity or at night while asleep 
✓ History of prior back injury  
 
(iii)  Otherwise in general good health 
  
b) Physical Examination:  
 
At least three of the following six are reported: 
✓ Inability/difficulty straightening into normal posture while standing 
✓ Particular activities, such as sitting, standing, walking, driving, are limited, difficult or 
impossible 
✓ While lying in prone position, palpation of muscles in lower lumbar area reveals local 
tenderness and muscle spasm 
✓ Change in sensation and/or motor function of knees and ankles 
✓ Raising straight leg from supine position produces sciatica 
✓ Upon observation, there is no notable posture, spinal alignment or other back deformities  
  
c) Medication Use History: History of taking muscle relaxants or anti-inflammatory 
medications, either over-the-counter and/or prescription medications. 
 
d) Records and Diagnostic Testing:  
Where available, review of prior relevant medical records from the subject’s primary treating 
physician and review of confirmatory prior diagnostic testing, such as x-ray, MRI or CAT 
scan reports will be conducted.  
 
If the applicable medical records and diagnostic testing listed above are not available or 
have not been conducted, the study investigator will record and evaluate all applicable 
information and perform an x-ray, the results of which will then be reviewed and verified as 
consistent with the study condition before confirming study qualification. 
 
 
If following the above review, a definitive diagnosis of low back pain stemming from benign 
musculoskeletal problems wherein the etiology is lumbar sprain or strain - a stretch injury to the 
ligaments, tendons, and/or muscles of the low back - that occurs in the absence of any serious 
underlying pathology or nerve root compromise cannot be made, or other possible etiologies of 
the low back pain are identified or cannot be satisfactorily ruled out, the subject will not qualify 
for participation in the clinical study. 
 
➢ The subject’s presenting low back pain is episodic chronic, defined as: 
 
• ongoing lower back pain having occurred over at least the preceding three months, with lower 
back pain having occurred on at least 15 days of each of the preceding 3 months, and 
• each individual episode of lower back pain over the preceding 3 months having lasted for a 
period of at least 24 hours followed by a subsequent period of at least 24 hours without pain  
 
➢ The subject’s self-reported Degree of Pain rating on the 0-100 VAS pain scale is 40 or greater  
➢ Subject is willing and able to refrain from consuming any over-the-counter and/or prescription 
medication and/or herbal supplements intended for the relief of pain and/or inflammation, 
including muscle relaxants throughout the course of study participation, except for the specified 
study pain relief medication  
➢ Subject is willing and able to refrain from engaging in any non-study procedure therapies for the 
management of his or her low back pain throughout the course of study participation, including 

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conventional therapies such as physical therapy, occupational therapy and hot or cold packs, 
as well as alternative therapies such as chiropractic care and acupuncture 
➢ Subject agrees and is able to complete the Subject Daily Diary, as applicable, throughout the 
course of his or her participation in the study  
➢ 18 years of age or older 
➢ Male or female 
➢ Subject’s primary language is English 
 
EXCLUSION CRITERIA 
 
A subject who satisfies any of the following criteria will be excluded from study participation: 
 
➢ The subject’s presenting primary pain is located outside or in addition to the region of the lower 
back, right and/or left side(s); that is, on the region of the back above the lowest rib and/or below 
the crease of the buttocks  
➢ Subject’s low back pain is undiagnosed, or has been diagnosed by a qualified medical 
professional as being other than that of benign musculoskeletal origin wherein the etiology is 
lumbar sprain or strain - a stretch injury to the ligaments, tendons, and/or muscles of the low 
back - that occurs in the absence of any serious underlying pathology or nerve root compromise 
➢ Subject’s low back pain has been diagnosed by a qualified medical professional as being in 
whole or in part due to one or more of the following origins, or any one or more of the following 
etiologies of the subject’s low back pain cannot be satisfactorily ruled out: 
✓ Mechanical: such as apophyseal osteoarthritis; diffuse idiopathic skeletal hyperostosis; 
degenerative discs; Scheuermann's kyphosis; s ("slipped disc"); thoracic or lumbar spinal 
stenosis; spondylolisthesis and other congenital abnormalities; fractures; leg length 
difference; restricted hip motion; misaligned pelvis - pelvic obliquity; anteversion or 
retroversion; and abnormal foot pronation  
✓ Inflammatory: seronegative spondylarthritides (e.g. ankylosing spondylitis); rheumatoid 
arthritis; infection - epidural abscess or osteomyelitis  
✓ Neoplastic: bone tumors (primary or metastatic); and intradural spinal tumors  
✓ Metabolic: osteoporotic fractures; osteomalacia; ochronosis; and chondrocalcinosis.  
✓ Psychosomatic: Tension myositis syndrome  
 
➢ Non-organic pain, defined as demonstration of positive findings for three or more of the five 
signs in the ‘Waddell’s Signs of Inorganic Behavior’ list indicating a non-organic or psychological 
component to chronic low back pain, as follows: 
 
✓ Tenderness that is superficial and widespread and/or nonanatomic tenderness (skin 
discomfort on light palpation or tenderness crossing over non-anatomical boundaries) 
✓ Simulation of pain with sham maneuvers; i.e. with axial loading and simulated rotation 
(eliciting pain when pressing down on the top of the patient’s head or rotating the shoulders 
and pelvis together should not be painful). 
✓ Distraction, such that less pain is reported for previously positive pain tests when attention is 
diverted, such as when performing a distracted straight leg raise test. For example, 
distraction is demonstrated if the subject complains of pain on straight leg raise, but not if the 
examiner extends the knee with the patient seated at another time during the evaluation 
✓ Regional disturbances: regional weakness or non-atomic sensory changes which deviate 
from accepted neuroanatomy (such as sensory loss in an entire extremity or side of the body 
or weakness that is non consistent and jerky; i.e. ‘cogwheeling’) 

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✓ Overreaction, defined as exaggerated or ‘disproportionate’ painful response to a stimulus 
that is not reproduced when the same stimulus is given later; subjective signs regarding the 
subject’s demeanor and reaction to testing  
 
➢ Known herniated disc injury 
➢ Known osteoporosis with compression fractures 
➢ Osteoporosis defined as both of the following:  
✓ a Total SCORE on the Simple Calculated Osteoporosis Risk Estimation (SCORE) screening 
questionnaire of > 6, and 
✓ DEXA T-score ≤ -2.5    
 
If total SCORE is ≤ 6, then DEXA bone density scanning will not be performed as osteoporosis 
is not indicated and the subject will remain eligible based on this criteria to continue with study 
qualification evaluation. 
 
➢ Congenital deformity of spine 
➢ Current, active chronic pain disease: chronic fatigue syndrome, fibromyalgia, endometriosis, 
inflammatory bowel disease, interstitial cystitis. 
➢ Cancer or treatment for cancer in the past 6 months, including tumors of the spinal cord 
➢ Subject’s presenting low back pain is not episodic chronic, defined as one or more of the 
following being present: 
 
✓ lower back pain has not been ongoing over at least the preceding three months or has been 
ongoing for less than the preceding 3 months 
✓ lower back pain has occurred on less than 15 days of each of the preceding 3 months 
✓ each individual episode of lower back pain over the preceding 3 months has lasted for a 
period of less than 24 hours 
✓ period of time between individual episodes of lower back pain over the preceding 3 months 
has been less than 24 hours  
 
➢ Subject’s self-reported Degree of Pain rating on the VAS pain scale is less than 40 
➢ Use of any one or more of the following analgesics, or an equivalent, within 7 days prior to 
commencement of administration of the study procedure protocol with the Erchonia® FX-635™:  
✓ paracetamol 
✓ Compound analgesics 
✓ Topical analgesics: patches, creams and lotions 
 
N.B.: If any of the above analgesics have been taken within 7 days prior to commencement of 
administration of the study procedure protocol, the subject will remain eligible for study 
participation if he or she agrees to refrain from use of the analgesic(s) for 7 days prior to 
commencement of study procedure administration. 
 
➢ Use of the following muscle relaxants within the prior 30 days:  
✓ cyclobenzaprine (Lexeril, Fexmid) 
✓ diazepam (Valium) 
✓ meprobamate (Miltown®, Equinil®, Equagesic®, Meprospan®)  
 
N.B.: If any of the above muscle relaxants have been taken within 30 days prior to 
commencement of administration of the study procedure protocol, the subject will remain 
eligible for study participation if he or she agrees to refrain from use of the muscle relaxant(s) 

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until 30 days of non-use prior to commencement of study procedure administration has been 
attained. 
 
➢ Use of any of the following muscle relaxants within 7 days prior to commencement of 
administration of the study procedure protocol with the Erchonia® FX-635™:  
✓ Carisoprodal (Soma®, Sodol®, Soprodol®, Soridol®) 
✓ Metaxalone (Skelaxin, Robaxin) 
  
N.B.: If any of the above muscle relaxants have been taken within 7 days prior to 
commencement of administration of the study procedure protocol, the subject will remain 
eligible for study participation if he or she agrees to refrain from use of the muscle relaxant(s) 
until 7 days of non-use prior to commencement of study procedure administration has been 
attained 
 
➢ Use of any of the following antidepressants that has been initiated within 30 days prior to 
commencement of administration of the study procedure protocol with the Erchonia® FX-635™:  
✓ duloxetine (Cymbalta®, Effexor) 
✓ amitriptyline 
✓ imipramine (Tofranil) 
✓ clomipramine (Anafranil) 
✓ nortriptyline (Pamelor) 
✓ desipramine (Norpramin) 
✓ SSRIs (selective serotonin reuptake inhibitors) e.g. Paxil, paroxetine, fluoxetine (Prozac) 
 
➢ Subject is not willing, or is unable to refrain from engaging in any non-study procedure OTC and 
prescription medications and treatments and therapies for the management of his or her low 
back pain throughout study participation, including conventional therapies such as physical 
therapy, occupational therapy and hot or cold packs, as well as alternative therapies such as 
chiropractic care and acupuncture 
➢ Subject does not agree or is unable to complete the Subject Daily Diary, as applicable, 
throughout the duration of his or her study participation  
➢ Systemic corticosteroid therapy or narcotics have been consumed within 30 days (inhaled and 
topical corticosteroids are permitted) prior to commencement of study procedure administration  
➢ Local or epidural injection of corticosteroids, as well as injections of corticosteroids in the back 
within 3 months prior to commencement of study procedure administration 
➢ Botulinum toxin (Botox®) injection for chronic low back pain within 4 months prior to 
commencement of study procedure administration 
➢ Active infection, wound or other external trauma to the areas to be treated with the laser 
➢ Prior surgery to the back or spine  
➢ Medical, physical or other contraindications for or sensitivity to light therapy 
➢ Pregnant, breast feeding, or planning pregnancy prior to the end of study participation 
➢ Serious known mental health illness such as dementia or schizophrenia; psychiatric 
hospitalization in past two years 
➢ Mental illness/incompetence defined according to the following Diagnostic and Statistical 
Manual of Mental Disorders-V (DSM-V) definition and criteria: A mental disorder is a syndrome 
characterized by each of the following:  
 
✓ A clinically significant disturbance in an individual's cognition, emotion regulation, or 
behavior that reflects a dysfunction in the psychological, biological, or developmental 
processes underlying mental functioning in the individual   

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✓ The consequences of the mental disorder are usually associated with clinically significant 
distress in social, occupational, or other important activities, or with disability 
✓ The dysfunctional cognitions and/or behaviors and significant distresses are not merely an 
expectable response to a common stressor or loss (e.g. death of a loved one) or a culturally 
sanctioned response to a particular event (e.g. trance states in religious rituals).  
✓ The dysfunctional cognitions and/or behaviors and significant distresses are no primarily a 
results of socially deviant behavior (e.g., political, religious, or sexual) or conflicts that are 
primarily between the individual and society  
 
➢ Current and/or prior history of alcohol and/or other substance abuse, defined according to the 
following Diagnostic and Statistical Manual of Mental Disorders-V (DSM-V) definition and 
criteria that collectively defines alcohol and substance abuse as a “substance use disorder”: 
a problematic pattern of using alcohol or another substance that results in impairment in daily 
life or noticeable distress. Diagnosis of substance use disorder according to the DSM-5 requires 
satisfaction of a minimum of 2 of the following 11 symptoms within a 12-month period: 
 
1. Consuming more alcohol or other substance (larger amounts or for longer periods) 
than originally planned 
2. Worrying about stopping or consistently failed efforts to control one’s use of a substance 
3. Spending a large amount of time using and/or recovering from use of a substance, or doing 
whatever is needed to obtain a substance 
4. Use of a substance results in failure to ‘fulfill major role obligations’ such as those at home, 
work or school. 
5. ‘Cravings’ or urges to use a substance 
6. Continuing the use of a substance despite health problems caused or worsened by it, 
including mental health problems (such as depressed mood, sleep disturbance, anxiety, or 
“blackouts”) or physical health. 
7. Continuing or repeated use of a substance despite its having negative effects on 
relationships with others. 
8. Continuing or repeated use of the substance in a dangerous situation (e.g., when 
operating heavy machinery or driving a car) 
9. Giving up or reducing important social, occupational or recreational activities because of the 
substance use 
10. Building up a tolerance to the alcohol or drug. Tolerance is defined by the DSM-5 as 
“either needing to use noticeably larger amounts over time to get the desired effect or 
noticing less of an effect over time after repeated use of the same amount.” 
11. Experiencing withdrawal symptoms after stopping use of a substance that can be relieved 
by taking more of the substance. According to the DSM-V definition and criteria, key 
‘withdrawal symptoms’ include: ‘anxiety, irritability, fatigue, nausea/vomiting, hand tremor or 
seizure in the case of alcohol.’ 
 
Evaluation for satisfaction of the DSM-V ‘substance use disorder’ criteria will be conducted both 
with respect to the preceding 12 month period (current abusers) and with respect to any 12-
month period in the past (history of prior abuse). 
 
➢ Developmental disability or cognitive impairment that in the opinion of the investigator would 
preclude adequate comprehension of the informed consent form and/or ability to record the 
necessary study measurements 
➢ Involvement in litigation and/or receiving disability benefits related in any way to the parameters 
of the study 

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➢ Subject is less than 18 years of age  
➢ Participation in a clinical study or other type of research in the past 30 days 
➢ Subject’s primary language is other than English 
 
WASHOUT PHASE: 48 HOURS PRIOR TO COMMENCEMENT OF THE PRE-PROCEDURE 
EVALUATION PHASE 
 
The pre-procedure washout phase comprises the 48-hour period immediately preceding the pre-
procedure evaluation phase, beginning upon waking on the first 24-hour period. 
 
At the start of the pre-procedure washout phase, the subject commences his or her required 
abstinence from use of non-study related medications and therapies for the relief of his or her low 
back pain and also commences the as-needed consumption of the study rescue medication for his 
or her low back pain that will continue through to the end of the post-procedure evaluation phase. 
 
WASHOUT PHASE MEASURES 
 
On each day of the two-day pre-procedure Washout Phase, the subject records the following 
measures, as outlined in the STUDY TEST BATTERY section above. 
 
➢ Subject Daily Diary (all applicable measures) 
➢ Visual Analog Scale (VAS) Degree of Pain Rating: recorded upon waking on each morning of 
the two-day pre-procedure Washout Phase 
 
CONFIRMATION OF CONTINUED SUBJECT STUDY ELIGIBILITY 
 
Prior to the subject commencing the pre-procedure evaluation phase of the study, the investigator 
reviews the information recorded in the pre-procedure Washout Phase Subject Daily Diary and 
determines the average of the 2 low back pain VAS degree of pain ratings recorded by the subject 
during the Washout Phase. The calculated 2-day washout phase average VAS pain rating will 
become the subject’s Baseline VAS pain rating for the purpose of study success evaluation.  
 
In order for the subject to remain qualified for study participation, the following two criteria must be 
satisfied: 
 
(i) There is no information recorded in the Subject Daily Diary that would render a subject ineligible 
for continued study participation, such as use of unapproved medications; and 
(ii) The subject’s 2-day Washout Phase average VAS score must be upheld at 40 or greater. If it is 
less than 40, the subject’s participation in the study ends at this time. 
 
SUBJECT RANDOMIZATION TO PROCEDURE GROUP  
 
A fully qualified subject is randomly assigned to Procedure Group A or to Procedure Group B, 
following the methodology outlined above in the STUDY DESIGN section of the protocol. 
 
PRE-PROCEDURE EVALUATION PHASE 
 
The pre-procedure evaluation phase commences on the day following successful completion of the 
two-day pre-procedure Washout Phase and following confirmation of continued subject study 
eligibility. During the pre-procedure evaluation phase, the following is recorded as outlined in the 
STUDY TEST BATTERY section above. 
 

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BASELINE VARIABLES 
 
➢ Baseline Low Back Pain Variables 
➢ Prior Treatment Approaches 
➢ Baseline Concomitant Medication and Therapy Use 
➢ Subject Demographics 
 
PRE-PROCEDURE OUTCOME ASSESSMENTS  
 
➢ Range of Motion (ROM) 
➢ Visual Analog Scale (VAS) Degree of Pain Rating 
➢ Oswestry Disability Index (ODI)/Oswestry Low Back Pain Questionnaire  
 
 
 

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PROCEDURE ADMINISTRATION PHASE 
 
The procedure administration phase is of 4 weeks duration and comprises 8 test site visits evenly 
spaced across the 4 weeks for procedure administrations.  
 
PROCEDURE ADMINISTRATION PROTOCOL   
 
➢ The procedure administration phase of the study will commence within one hour subsequent to 
completion of the pre-procedure phase.    
➢ The procedure administration phase will extend over 4 consecutive weeks.  
➢ Each subject will receive 8 total procedures with the Erchonia® FX-635™ across the consecutive 
4-week procedure administration phase: 2 procedure administrations per week, each procedure 
administration approximately evenly spaced (3 to 4 days apart). 
➢ Each procedure administration lasts a total of 20 minutes 
➢ Each procedure administration with the Erchonia® FX-635™ will be administered at the 
investigator’s test site. 
➢ The procedure administration protocol for each session is as follows: 
 
1. The subject enters the procedure room and lies comfortably on his or her stomach on the 
table such that the back area of the subject’s body is facing upwards. 
2. The subject is correctly fitted with the NoIR protective eyewear. 
3. The center diode of the Erchonia® FX-635™ is positioned at a distance of 6 inches above the 
subject’s back, centered on the lower back, with the other 2 diodes centered one each on 
each of the 2 hip flexors.  
4. The Erchonia® FX-635™ is activated for 20 minutes. Each scanner emits to the subject a 
laser beam of approximately 17 mW with a wavelength of 635 nm, and creates a spiraling 
circle pattern totally random and independent from the others. These patterns overlap each 
other to guarantee total coverage within the target area. The target area is approximately 8 x 
10 inches or 80 square inches (approx. 516 square centimeters).   
5. The subject’s protective eyewear is removed and the session is over. 
 
Justification for the Procedure Administration Protocol  
 
In the prior clinical study evaluating efficacy of Erchonia LLLT on the reduction of low back pain, 
the procedure administration protocol implemented comprised six 15-minute procedure 
administrations over 3 weeks; 2 procedure administrations per week.  
 
While the results of this study demonstrated statistically significant efficacy of Erchonia active laser 
treatment over placebo, the effect (the clinically meaningful pain reduction outcome) appeared to 
develop at a slower rate over a longer period of time than that which had been demonstrated in 
prior Erchonia Corporation clinical studies for pain reduction indications such as for neck and 
shoulder pain (K100509) and for chronic heel (plantar fasciitis) pain (K132940), indicating that the 
condition of chronic low back pain is a more resistant to therapy than the other chronic pain 
conditions previously evaluated and therefore necessitates a slightly enhanced procedure 
administration protocol that does not increase the risk to the subject nor compromise subject safety 
in any way in its implementation. 
 
Therefore, it was decided that slight increments in and modifications to each of the procedure 
administration outputs variables was warranted to attain a comparable treatment effect for the 
reduction of chronic low back pain as had been attained in prior Erchonia Corporation pain reduction 
clinical trials, as shown in the comparative table below:        

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PROCEDURE ADMINISTRATION PHASE MEASURES 
 
DAILY MEASURES 
 
Commencing on the same day as the first study procedure administration with the Erchonia® FX-
635™, the subject begins to record all of the required information in the Subject Daily Diary, as 
applicable, at home, and continues to satisfactorily complete the Subject Daily Diary through each 
day of the procedure administration phase. 
 
The rescue pain medication (OTC Tylenol) use count on day one of the procedure administration 
phase will serve as the subject’s initial (baseline) pain medication count for the purpose of 
subsequent evaluation of change in utilization of pain relief medication throughout study 
participation.  
 
FOLLOWING EACH PROCEDURE ADMINISTRATION  
 
Within 10 minutes following administration of each of the 8 study procedure administrations with 
the Erchonia® FX-635™, the following will be recorded at the test site as outlined in the STUDY 
TEST BATTERY section above. 
 
➢ Visual Analog Scale (VAS) Degree of Pain Rating 
➢ Assessment Investigator’s Adverse Events Evaluation  
 
FOLLOWING THE FINAL PROCEDURE ADMINISTRATION  
 
In addition to the VAS pain rating recordings and the adverse events evaluation, within ten minutes 
of completion of the 8th and final procedure administration of the 4-week procedure administration 
phase of the study, the following will be recorded at the test site as outlined in the STUDY TEST 
BATTERY section above. 
 
ASSESSMENT AND EVALUATION TOOLS 
➢ Oswestry Disability Index (ODI)/Oswestry Low Back Pain Questionnaire  
➢ Range of Motion (ROM) 
➢ Subject Satisfaction With Study Outcome 
 
BLINDING EFFICACY EVALUATION  
➢ Subject Perceived Group Allocation and Rationale 
➢ Assessment investigator Perceived Subject Group Allocation and Rationale 
 
 
 
Treatment Parameter 
Initial Trial Treatment 
Parameter 
Modified Current Output 
Treatment Parameter 
Number of Treatments  
6 
8 
Duration of Treatment 
Administration  
3 weeks 
4 weeks 
Frequency of Treatment 
Administration  
2 times per week 
2 times per week 
Duration of Each Procedure 
Administration  
15 minutes 
20 minutes 

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POST-PROCEDURE ACTIVITIES 
    
POST-PROCEDURE EVALUATION PHASE  
The post-procedure administration evaluation phase of this study will commence immediately 
following completion of the procedure administration phase, and will last 2 months (8 weeks).  
 
POST-PROCEDURE EVALUATION TEST SITE VISITS AND MEASURES 
There will be 2 post-procedure evaluation visits at the test site.  
 
ONE MONTH POST-PROCEDURE EVALUATION  
One month after completion of the procedure administration phase, the subject returns for a test 
site visit to record the following measures as per the STUDY TEST BATTERY section above. 
 
➢ Visual Analog Scale (VAS) Degree of Pain Rating 
➢ Oswestry Disability Index (ODI)/Oswestry Low Back Pain Questionnaire  
➢ Range of Motion (ROM) 
➢ Assessment Investigator’s Adverse Events Evaluation  
 
STUDY ENDPOINT EVALUATION: TWO MONTHS POST-PROCEDURE EVALUATION   
Two months after completion of the procedure administration phase, the subject returns for a final 
test site evaluation visit. The two-month post-procedure evaluation visit will serve as the study 
endpoint evaluation visit, the evaluation point at which study success will be evaluated relative to 
baseline. At this visit, the following measures will be recorded as per the STUDY TEST BATTERY 
section above. 
 
ASSESSMENT AND EVALUATION TOOLS 
➢ Visual Analog Scale (VAS) Degree of Pain Rating 
➢ Oswestry Disability Index (ODI)/Oswestry Low Back Pain Questionnaire  
➢ Range of Motion (ROM) 
➢ Subject Satisfaction With Study Outcome 
➢ Assessment Investigator’s Adverse Events Evaluation  
 
BLINDING EFFICACY EVALUATION  
➢ Subject Perceived Group Allocation and Rationale 
➢ Assessment investigator Perceived Subject Group Allocation and Rationale 
 
AT-HOME POST-PROCEDURE EVALUATION PHASE MEASURES 
 
DAILY MEASURES 
The subject will continue to record all of the required information in the Subject Daily Diary, as 
applicable, at home, on each day of the two-month post-procedure administration phase. 
 
WEEKLY MEASURES 
At the end of each of post-procedure evaluation weeks 1, 2, 3, 5, 6, and 7, the subject will record 
the following in his or her home upon waking each morning, as outlined in the STUDY TEST 
BATTERY section above. These measures are already being recorded at the end of post-procedure 
weeks 4 and 8 as part of the scheduled test site visits. 
  
➢ Visual Analog Scale (VAS) Degree of Pain Rating 
➢ Oswestry Disability Index (ODI)/Oswestry Low Back Pain Questionnaire  
 
 

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TABLE OF SUBJECT EVENTS 
 
The following table provides a progressive summary of subject events throughout this study.  
PRE-PROCEDURE ACTIVITIES  
 
  STUDY QUALIFICATION  
1) A potentially well-suited and interested candidate for participation in the study attends the 
investigator’s office. 
2) The investigator reviews the informed consent form with the candidate.  
3) If the candidate continues to be interested and voluntarily signs the informed consent form, 
the study qualification evaluation phase of the study is performed. 
 
WASHOUT PHASE 
4) A qualified subject enters the 48-hour washout phase and partakes in the following: 
✓ Commencement of rescue pain medication only use 
✓ Completion of Subject Daily Diary 
✓ Daily VAS Degree of Pain recordings  
5) A subject whose continued study eligibility post-washout is confirmed is randomly assigned 
to procedure group. 
PRE-PROCEDURE MEASURES & VARIABLES 
 
➢ Baseline Low Back Pain Variables 
➢ Prior Treatment Approaches 
➢ Baseline Concomitant Medication and Therapy Use 
➢ Subject Demographics 
➢ VAS Degree of Pain Rating 
➢ Oswestry Disability Index (ODI)/Oswestry Low Back Pain Questionnaire  
➢ Range of Motion (ROM) 
 
PROCEDURE ADMINISTRATION PROTOCOL  
 
Eight 20-minute study procedure administrations with the Erchonia® FX-635™ over 4 
consecutive weeks, 2 treatment administrations per week, administered at the test site. 
PROCEDURE ADMINISTRATION PHASE MEASURES 
 
DAILY MEASURES 
➢ Subject Daily Diary 
 
FOLLOWING EACH PROCEDURE ADMINISTRATION 
➢ VAS Degree of Pain Rating 
➢ Assessment Investigator’s Adverse Events Evaluation  
 
FOLLOWING THE FINAL PROCEDURE ADMINISTRATION 
➢ Oswestry Disability Index (ODI)/Oswestry Low Back Pain Questionnaire  
➢ Range of Motion (ROM) 
➢ Subject Satisfaction With Study outcome 
➢ Subject Perceived Group Allocation and Rationale  
➢ Assessment Investigator Perceived Subject Group Allocation and Rationale 

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POST-PROCEDURE ACTIVITIES 
 
AT-HOME MEASURES 
 
DAILY 
➢ Subject Daily Diary 
 
WEEKLY: At the end of each of weeks 1, 2, 3, 5, 6, & 7 of the post-procedure administration 
phase: 
➢ VAS Degree of Pain Rating 
➢ Oswestry Disability Index (ODI)/Oswestry Low Back Pain Questionnaire  
 
TEST SITE EVALUATION VISITS 
 
ONE MONTH POST-PROCEDURE EVALUATION  
 
➢ VAS Degree of Pain Rating  
➢ Oswestry Disability Index (ODI)/Oswestry Low Back Pain Questionnaire  
➢ Range of Motion (ROM) 
➢ Assessment Investigators’ Adverse Events Evaluation 
  
STUDY ENDPOINT EVALUATION: TWO MONTHS POST-PROCEDURE EVALUATION  
 
➢ VAS Degree of Pain Rating 
➢  Oswestry Disability Index (ODI)/Oswestry Low Back Pain Questionnaire  
➢ Range of Motion (ROM) 
➢ Subject Satisfaction With Study Outcome 
➢ Subject Perceived Group Allocation and Rationale 
➢ Assessment Investigator’s Perceived Subject Group Allocation and Rationale 
➢ Assessment Investigators’ Adverse Events Evaluation 
  
 
 
ADVERSE EVENTS  
 
At each evaluation and procedure administration test site visit throughout the clinical study, and at 
any other time throughout the duration of the clinical trial that is necessary, any and all potential 
adverse events reported by a subject or observed by an investigator will be recorded on the case 
report form, and subsequently evaluated by a suitably qualified independent reviewer for 
determination of relationship to the study treatment and whether or not any corrective action needs 
to be taken. All potential adverse events recorded will be appropriately reported to the governing 
IRB, as applicable. 
 
It is unlikely and not expected that any adverse events will result from implementation of this clinical 
study protocol. Prior clinical trials using low level laser light have not typically yielded any adverse 
events or reactions. However, potential adverse events that may feasibly occur from application of 
the Erchonia® FX-635™ include, but are not necessarily limited to: skin irritation, discoloring, rash, 
indentations and infection. 
 
 

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STATISTICAL ANALYSIS 
 
PRIMARY EFFICACY OUTCOME MEASURE: CHANGE IN SUBJECT SELF-REPORTED VAS 
PAIN RATING FROM BASELINE TO STUDY ENDPOINT   
 
Primary efficacy outcome measure for this clinical study will be a statistically significant difference 
in the proportion of subjects between test and control groups who achieve a clinically meaningful 
and statistically significant decrease in self-reported VAS pain rating from baseline to study 
endpoint.    
 
Subjects meeting Individual Success Criteria 
The individual subject success criteria is defined as a 30% or greater decrease in self-reported VAS 
pain rating at study endpoint relative to baseline. 
 
Overall Study Success Criteria.  
Overall study success criteria is defined as at least a 35% difference between procedure groups, 
comparing the proportion of individual successes in each group. It is anticipated that about 55% of 
subjects in the test group will meet the individual success criteria and about 20% of subjects in the 
control group will meet the individual success criteria.  
 
The clinical relevance of a 30% change in VAS score has been well previously established by FDA’s 
Division of Surgical, Orthopedic and Restorative Devices through numerous pre-IDE reviews, the 
results of said studies that were subsequently used to successfully support various pain-reduction 
related indications for various Erchonia Corporation light therapy devices under Product Code NHN 
for the 510(k)s listed below over the past 8 years: 
 
1. K101430; 06/22/10: “The MLS-AC DermaScanner™ is indicated, while using the red diodes, 
for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of 
musculoskeletal origin.” 
 
2. K100509; 06/08/10: “The Erchonia THL1 is indicated for use in providing temporary relief of 
minor chronic neck and shoulder pain of musculoskeletal origin.” 
 
3. K072206; 04/24/08: “The Erchonia EML Laser is indicated for the temporary reduction in post -
surgery pain at 24 hours after surgery following breast augmentation surgery.” 
 
4. K050672; 06/02/05: “The Erchonia EVRL Laser is generally indicated while using the red diode 
for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of 
musculoskeletal origin.” 
 
5. K041139; 09/30/04: “The Erchonia EML Laser is indicated as an adjunct to liposuction 
procedures of the thighs, hips and stomach for reduction of pain associated with the recovery 
process.” 
 
 
 

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Evaluation Time Point 
The study end evaluation time point at which study success will be analyzed is at two months post-
procedure evaluation relative to baseline evaluation.   
 
The rationale and validation for the timing of the study endpoint is based a combination of factors, 
as follows:  
 
➢ The long-term follow-up results of the following Erchonia Corporation clinical trial that 
successfully supported the following FDA 510(k) clearance for market, demonstrated that while 
a clinically meaningful and statistically significant reduction in pain did occur over the course of 
the treatment administration period, the therapeutic effects prevailed, extended and intensified 
over the longer term, and the difference in efficacy results between active and control groups 
widened for chronic pain conditions.  
 
Device: Erchonia® Allay™ 
510(k)#: K132940  
Manufacturer: Erchonia Corporation 
Device Class: Class II 
Product Code: NHN 
Clearance Date: 04/14/14 
Indication for Use: The Erchonia® Allay™ laser is indicated as an adjunct to reducing chronic 
heel pain arising from plantar fasciitis.  
 
The chart below shows the average VAS heel pain ratings for 23 subjects in the above clinical 
trial who had been assigned to the active device group and were followed through to 12 months 
post-procedure. It can be seen that while at study endpoint evaluation (2 weeks post-
procedure), a statistically significant and clinically meaningful decrease in mean VAS ratings 
occurred, this effect prevailed through to 12 months post-procedure follow up to almost 
negligible recordable pain levels.  
 
69.83
42.11
11.83
6.89
0
10
20
30
40
50
60
70
80
Baseline
Endpoint
6 Months
12 Months

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We believe this phenomenon occurs for two primary reasons: 
 
(i) It is hypothesized from the understanding of the general mechanism of operation of LLLT to 
pain reduction (as explained in detail in the clinical study protocol), that the increase in the 
production of ATP and activate enzymes in the underlying targeted cells of the tissue that 
cultivate a growth factor response within the cells and promote tissue healing, and new, 
healthier cell and tissue growth to strengthen and support muscles and tendons, to restore 
strength and flexibility and to protect against further damage, together with the anti-inflammatory 
properties of low level lasers that reduce nerve irritation and inflammation to provide pain relief, 
neither ends nor peaks at completion of treatment administration, but rather the therapeutic 
properties of the LLLT continue to take effect and to intensify over the prevailing weeks and 
months.  
 
(ii) Inherent in individuals with chronic pain conditions is the hope in finding a means of substantial 
and durable pain relief, which is observable in the typical early onset high placebo effect attained 
in studies evaluating therapeutic pain relief modalities. Therefore, the need for a longer-term 
evaluation period in order for subjects to distinguish true and enduring pain relief from that of 
wishful pain relief, and for the true active therapeutic effect versus placebo to prevail is evident. 
 
The above referenced clinical study evaluating the efficacy of Erchonia LLLT in reducing chronic 
heel pain arising from plantar fasciitis successfully supported the following FDA 510(k) 
clearance for market: 
 
Device: Erchonia® Allay™ 
510(k)#: K132940  
Manufacturer: Erchonia Corporation 
Device Class: Class II 
Product Code: NHN 
Clearance Date: 04/14/14 
Indication for Use: The Erchonia® Allay™ laser is indicated as an adjunct to reducing 
chronic heel pain arising from plantar fasciitis.  
 
➢ The findings of this study are consistent with and supported by anecdotal reports by 
investigators in this study and of other medical professionals who regularly apply Erchonia LLLT 
in their practices. Many of these practitioners have reported to Erchonia Corporation that 
patients treated with the Erchonia laser for neck and shoulder pain and heel pain have reported 
anecdotally at follow-up visits many months after treatment end that their pain has continued to 
lessen over time. 
 
➢ Further support comes from prior clinical trials by other Sponsors whose results have been 
successfully applied to supporting 510(k) market clearances for LLLT devices to the reduction 
of pain associated with chronic pain conditions. Most notable of these is the MicroLight 830 
LLLT study whose results were used to support the indication of the reduction of pain associated 
with the musculoskeletal condition of carpal tunnel syndrome (K010175). In this study, the study 
evaluation endpoint was 12 weeks (3 months) post-procedure. 
 
It is for all of the above reasons that it was decided that in the present clinical study, a longer post-
procedure endpoint evaluation is warranted to attain a more accurate representation of optimal 
treatment effect of LLLT application with the Erchonia® FX-635™ laser device to the chronic pain 
condition of low back pain of musculoskeletal origin. 
 

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Hypotheses 
 
➢ Null Hypothesis: There will be no statistically significant difference in the proportion of individual 
successes, as defined, between the test and control groups. 
➢ Alternative Hypothesis: There will be a statistically significant difference in the proportion of 
individual successes, as defined, between the test and control groups, to the effect of 35% or 
greater. 
 
PRIMARY EFFICACY OUTCOME STATISTICAL EVALUATION METHODS 
 
➢ Intent to Treat (ITT) Principle: Primary efficacy analysis will be according to the intent to treat 
(ITT) principle; wherein subjects will be included in the analysis if they were randomized to study 
procedure group, had a valid baseline (pre-procedure) visit including the required low back pain 
VAS recording; and received at least the first study procedure administration.  
 
➢ Missing data will be handled through Last Observation Carried Forward (LOCF): by carrying 
forward the last recorded observation to fill in the subsequent missing value.  
 
➢ Per-Protocol Analysis will also be performed for the set of all subjects who were randomized 
to procedure group and completed the study according to the full protocol.  
 
➢ Primary analysis of efficacy will be according to intent to treat (ITT) analysis through the 
application of: 
 
1) Fisher's exact test to compare the proportion of success between the test and the control 
groups, considering that randomization has been diligently conducted and important 
covariates between the two groups are well balanced. 
 
2) Parametric ANCOVA model analysis with the mean change from baseline to study endpoint 
in low back pain rating on the VAS as the dependent variable, procedure group as the 
independent variable of interest and baseline low back pain VAS rating as a covariate. A two-
tailed significance level of 5% will be considered to be statistically significant.  
  
➢ Covariates: The following potential covariate baseline variables will be adjusted, as applicable, 
through application of an ANCOVA analysis for the continuous variables and linear regression 
analysis for categorical variables. 
 
✓ Baseline Oswestry Disability Index (ODI) score 
✓ Age   
 
 
 
 
 
 
 
 
 
 
 
 

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SUPPORTIVE SECONDARY OUTCOME MEASURE: OSWESTRY DISABILITY INDEX (ODI) 
SCORE 
 
ODI scores will be considered a secondary endpoint to support the primary pain evaluation outcome 
measure of subject self-reported degree of low back pain levels recorded on the 0-100 Visual 
Analog Scale (VAS).  
 
The ODI score will be evaluated as follows: 
 
➢ Change in ODI score from study baseline to endpoint evaluation will be calculated, with a 
clinically meaningful change determined to be 10% decrease in points, based on the established 
minimum detectable change (90% confidence) of 10% points. Statistical significance of the 
change will be evaluated through parametric t-test and ANCOVA analysis, with a two-way 
significance level of 5% considered to be statistically significant.  
➢ Correlation analysis will be performed to evaluate the strength of the relationship between the 
change in VAS ratings and the corresponding change in ODI scores from baseline to study 
endpoint evaluation.   
 
ADDITIONAL SUPPORTIVE OUTCOME MEASURES EVALUATION  
 
The following additional supportive outcome measures will also be evaluated as exploratory 
qualitative trending of the following, without claims of statistical significance: 
 
a) mean changes in low back pain VAS ratings across and between all study evaluation time 
points, within and between procedure groups 
b) mean changes in ODI scores across and between all study evaluation time points, within and 
between procedure groups 
c) Mean changes in each of the range of motion measurements across and between all evaluation 
points, within and between procedure groups 
d) Differences in satisfaction with Study Outcome Ratings between procedure groups at both 
evaluated time points, and change between   
 
EVALUATION OF RESCUE PAIN MEDICATION USE 
 
The impact of rescue pain medication use during the study will be evaluated using descriptive 
statistics and qualitative comparisons. 
 
BLINDING EFFICACY EVALUATION  
 
Blinding efficacy evaluation will be conducted through analysis of findings from the Subject and the 
Assessment Investigator Perceived Subject Group Allocation and Rationale responses, recorded 
at completion of the four-week procedure administration phase and again at study endpoint 
evaluation at 2 months post-procedure administration. 
 
Statistical evaluation of blinding efficacy will be performed as follows: 
 
(i) The percentage of subjects who correctly perceived their procedure group assignment and the 
percentage of subjects who did not correctly perceive their procedure group assignment will be 
calculated. 

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(ii) The percentage of times the assessment investigators correctly perceived subjects’ procedure 
group assignment and the percentage of times the assessment investigators did not correctly 
perceive subjects’ procedure group assignment will be calculated. 
(iii) The Fischer’s Exact categorical analysis technique for comparison of proportion of 
successes (accurate procedure group assignment determination) and failures (inaccurate 
procedure group assignment determination) between subject groups will be performed for each 
of the subject and assessment investigator determinations. 
(iv) Qualitative analysis confirmation: Evaluation of the comments provided by the subject and 
assessment investigators in the rationale section to explain the guess at group assignment will 
be evaluated and interpreted as follows to either support or negate the numerical findings:   
 
➢ Positive blinding efficacy will be supported through qualitative assessment of comments 
provided to support perceived group assignment that pertain to the determination being 
made based on treatment efficacy or lack thereof; e.g.: ‘I can bend down and walk around 
more easily and with less pain than before, so I believe I got the real treatment’ or ‘I haven’t 
noticed any change in my low back pain, so I believe I got the fake treatment.’ 
 
➢ Blinding will be determined to have failed if comments provided to support perceived group 
assignment pertain to factors such as sensation/visual clues, such as ‘I saw/didn’t see a 
light go on’, or other factors that pertain to blinding having been compromised such as ‘I 
overheard the doctor saying I wasn’t getting the real treatment.’ 
 
SAFETY ANALYSES  
 
Safety analyses will be based on all subjects who were randomized to the test or to the placebo 
procedure group. Safety will be assessed by evaluating and comparing frequency and incidence of 
observed and/or reported adverse events between test and placebo procedure groups. A chi-
square test with a continuity correction will be performed to compare the percentage of subjects 
who had adverse events between test and placebo group subjects.  
 
Analysis of results will be performed by individual test site and pooled across test sites. Application 
of a balanced test-control group study design incorporating a varied block by test site randomization 
procedure will contribute to statistical justification of pooling data across the different test sites.

 
 
 
 
 
 
 
 
 
 
 
 
 
 
END OF DOCUMENT