Effects of Osteopathic Manipulative Treatment (OMT) and Bio Electro-Magnetic Regulation (BEMER) Therapy on Low Back Pain in Adults.
Phase: NA
Conditions: Musculoskeletal Pain
Sponsor: Lake Erie College of Osteopathic Medicine

 1
Title: Effects of Osteopathic Manipulative Treatment and Bio Electro-Magnetic Regulation 
Therapy on Low Back Pain in Adults. 
 
NCT04704375 
 
June 13, 2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Principal Investigator:  
 
Santiago Lorenzo, Ph.D., M.S., M.S. (Med Ed) 
Lake Erie College of Osteopathic Medicine, Bradenton Florida 
Phone: (941) 782-5974 
Email: slorenzo@lecom.edu 
 
Research Title: 
 
Effects of Osteopathic Manipulative Treatment (OMT) and Bio Electro-Magnetic Regulation 
(BEMER) Therapy on low back pain in adults. 
 
Research Purpose: 
 
The aim of this project is to investigate the individual and combined effects of Osteopathic 
Manipulative Treatment (OMT) and Bio Electro-Magnetic Regulation (BEMER) Therapy on low 
back pain in adults. 
 
Study Summary: 
It is clear that low back pain (LBP) is a major challenge in our society, which can lead to severe 
disability in many individuals. Although there are several different treatments and approaches 
to help individuals with LBP, the number affected by this condition has been steadily increasing.  
 
OMT has been shown to be helpful in the treatment of LBP. In fact, the use of OMT has been 
shown to increase mobility of the lumbar myofascial tissues, visceral motion and decrease pain 
in patients with LBP. Bio Electro-Magnetic Regulation (BEMER) Therapy  is a therapeutic 
modality that deploys a biorhythmically defined stimulus through a Pulsed Electromagnetic 
Field (PEMF), which leads to an increase in blood flow. The positive effects of BEMER on the 
circulation has been shown to result in significant increases in arteriovenous oxygen difference, 
number of open capillaries, arteriolar and venular flow volume, and flow rate of red blood cells 
in the microvasculature [1, 2]. Therefore, BEMER can potentially be used in the treatment of 
LBP by improving microcirculation in muscular tissue. In fact, BEMER with physiotherapy 
showed reductions in pain and fatigue acutely in patients with chronic low back pain [3]. A 
systemic review of randomized controlled trials that investigated whether PEMF was effective 
in low back pain showed there was decrease in pain intensity and improved functionality in 
individuals with different low back pain conditions [4].  
 
Therefore, it is plausible that the combination of OMT and BEMER therapy may help increase 
circulation to myofascial structures that influence low back restriction and pain. The purpose of 

 3
this study is to investigate the individual and combined effects of OMT and BEMER therapy on 
low back pain.   
  
Review of Literature: 
Low back pain (LBP) has become a major challenge in our society and has a relatively high 
incidence and prevalence [5]. Moreover, LBP currently affects people of all ages and is a leading 
contributor to disease burden worldwide [6]. Individuals affected by LBP  may experience this 
discomfort and associated disability for several months, and a proportion may remain severely 
disabled [7].  For nearly all people with low back pain, it is not possible to identify a specific 
nociceptive cause. Most people with new episodes of LBP may recover quickly; however, 
recurrence is common and in many cases, LBP becomes persistent and disabling [8].  
 
Despite the overabundance of treatments and approaches devoted to LBP, this back related 
disability and the number of individuals affected have steadily been increasing [9, 10]. During 
the past three decades, changes have been made to key recommendations in national clinical 
practice guidelines. In fact, currently there is a bigger emphasis placed on self-management, 
physical and psychological therapies, and some forms of complementary medicine (such as 
spinal manipulation, massage, acupuncture), and less emphasis on pharmacological and surgical 
treatments [11].  
 
Despite multiple clinical guidelines providing similar recommendations for managing low 
back pain, a substantial gap between evidence and practice exists [12]. Osteopathic 
manipulative treatment (OMT) is a distinctive modality used by osteopathic physicians to 
complement conventional management of LBP. There is considerable variability in OMT 
approaches when treating for LBP. Furthermore, osteopathic physicians combine conventional 
and complementary treatments when caring for patients with LBP. This increased variability in 
the approach to care for LBP patients requires more empirical data to determine the best 
approaches to treat LBP [13]. Franke et al. [14] conducted a meta-analysis that investigated the 
effect of OMT in LBP. The authors reported that some studies observed significant effect of 
OMT on pain [15-17], whereas other reported either a non-significant effect [18-20], or an 
effect in favor of the control treatment [19, 20]. It is clear that more research to better describe 
the effects of OMT on LBP is warranted.  
 
OMT is the application of hands-on forces to help improve physiologic function and/or support 
homeostasis that has been negatively altered by somatic dysfunction [21], which is an 
impairment of function of any area of the body system [22]. These impairments can occur at 
the muscles, fascia, bones, joints, ligaments, vasculature, lymphatics and nerves. When somatic 
dysfunction is diagnosed, using an osteopaths’ manual palpatory skills, it is treated with OMT. 
In general, OMT techniques can be classified as direct or indirect. Direct techniques such as 
muscle energy (ME), high velocity low amplitude (HVLA), soft tissue (ST), and myofascial release 
(MFR) engage the restrictive barrier and use a specifically applied force to correct the somatic 
dysfunction [21]. Indirect techniques such as MFR, counterstrain (CS), balanced ligamentous 

 4
tension (BLT) disengage from the restrictive barrier and the affected body part is moved into its 
freedom of motion [21].  
 
The etiology of low back pain is varied from visceral causes, to a lack of adequate blood flow to 
the muscles and musculoskeletal imbalance. Inadequate blood supply and/or inadequate 
oxygen consumption can influence muscle pain [23, 24]. The role of OMT is thought to primarily 
address the musculoskeletal component of back pain, which may help improve muscle blood 
flow. Two of the primary goals of treatment with osteopathic techniques are to restore mobility 
and decrease pain. Using trained palpatory skills to diagnose alterations in the fascial 
connections within the body, it is proposed that OMT techniques can help alleviate these 
alterations in the body that may lead to musculoskeletal disorders such as low back pain [25]. 
Many studies that use OMT as the intervention to reduce low back pain, utilize a combination 
of direct and indirect techniques [15, 18, 26, 27]. The use of myofascial release technique has 
been shown to increase mobility of the lumbar myofascial tissues, visceral motion and decrease 
pain in patients with non-specific low back pain using ultrasound diagnostics [28].  
 
One very promising alternative approach for the treatment of LBP is the use of Bio Electro-
Magnetic Regulation (BEMER) Therapy. BEMER is a therapeutic modality that deploys a 
biorhythmically defined stimulus through a Pulsed Electromagnetic Field (PEMF). This stimulus 
has a targeted effect on the microvasculature, and the primary effect is an improvement in 
tissue microcirculation [3]. The positive effects of vasomotion on the microcirculation has been 
shown to result in significant increases in arteriovenous oxygen difference, number of open 
capillaries, arteriolar and venular flow volume, and flow rate of red blood cells in the 
microvasculature [1, 2]. Therefore, BEMER can potentially be used in the treatment of LBP by 
improving microcirculation in muscular tissue.  
 
Though OMT has been shown to be effective clinically for patients in decreasing pain, little is 
known behind the specific mechanisms of action. It is believed all osteopathic techniques use 
the concepts of fascial connectivity throughout the body and therefore can help increase 
circulation and lymphatic flow [21, 29]. In one study, the use of OMT helped decrease 
autonomic and neuroendocrine markers in response to mental stress [30]. In modeled studies, 
OMT modalities like MFR and CS showed possible effects in modifying cytokine secretion, 
improving wound healing, and modifying muscle contraction [31]. These effects were shown to 
sometimes reverse repetitive muscle strain in the tissues. It is postulated that these strains may 
represent the phenomenon of somatic dysfunction. Another study showed improvement in 
lower extremity blood pressure, cell mass, intracellular water, basal metabolism, venous 
velocity, skin temperature, pain, and quality of life post MFR and physical therapy for post-
menopausal women with venous insufficiency [32]. As discussed previously, BEMER therapy has 
been shown to increase microcirculation. BEMER with physiotherapy showed reductions in pain 
and fatigue acutely in patients with chronic low back pain [3]. A systemic review of randomized 
controlled trials that investigated whether PEMF was effective in low back pain showed there 
was decrease in pain intensity and improved functionality in individuals with different low back 
pain conditions [4]. Therefore the results from these studies suggest that the combination of 

 5
OMT and BEMER therapy can potentially help increase circulation to myofascial structures that 
influence low back restriction and pain.   
 
Methodology 
I. 
Study Design 
a. Prospective, noninvasive study to examine the individual and combined effects 
of OMT and Bio Electro-Magnetic Regulation (BEMER) Therapy on low back pain 
in adults.  
b. Study treatment location: All treatments and post treatment measurements will 
be performed in the osteopathic manipulative therapy laboratory at Lake Erie 
College of Osteopathic Medicine, Bradenton.  Dr. Nicole Myers or Dr. Thomas 
Quinn, who are licensed osteopathic physicians, will be on call in the vicinity of 
the treatment location, however not necessarily in the room of treatment. 
c. Data Collection 
i. After written consent is obtained, the study coordinator will assign the 
participant a randomized study number to de-identify the participant. 
ii. To achieve our project’s goal, we will have 4 separate groups (OMT, 
BEMER, OMT+BEMER, and Placebo). OMT, BEMER, and placebo 
treatments will be performed by osteopathic medical students who have 
completed additional training given by a licensed osteopathic physician, 
to ensure uniform technique.  
iii. To control for anchoring bias, subjects will be randomized into one of the 
four groups: OMT, BEMER, OMT+BEMER, and Placebo. 
iv. Osteopathic Manipulation Diagnosis and Treatment Protocol 
Osteopathic Diagnosis and Screening 
1. Observe and Palpate Thoracic and lumbar muscles for TART 
(tenderness, asymmetry, restriction of motion, and tenderness) 
changes 
2. Lumbar intersegmental diagnosis: used to guide treatment with 
muscle energy technique 
3. Counterstrain Tenderpoint screening for the following muscles: 
psoas major, quadratus lumborum and piriformis- used to guide 
treatment with counterstrain technique 
4. Sacrum diagnosis: Spring test at the base of the sacrum for 
palpation of flexed or extended dysfunction 
5. Sacroiliac dysfunction: ASIS compression test – used to lateralize 
somatic dysfunction at sacroiliac joints 
 
Osteopathic Treatment/Techniques  
6. Regional thoracic myofascial release technique prone 
7. Lumbosacral fascia myofascial release technique prone 
8. Lumbar soft tissue unilateral pressure technique prone 
9. Lumbar muscle energy technique seated or lateral recumbent 

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10. Psoas, piriformis, quadratus lumborum counterstrain technique 
supine 
11. Sacrum balanced ligamentous tension technique supine 
12. Lumbosacral/Pelvic fascia Myofascial Release technique supine 
v. Second year osteopathic medical students will perform the duties of 
assessing and screening for somatic dysfunction in these regions, as well 
as the treatment modalities (as listed above). All treatment modalities 
were previously learned by the students during the osteopathic principles 
and practices (OPP) course. In addition, the students performing the 
treatments will receive further training by the OPP course director and 
OPP clinical faculty at LECOM-Bradenton. The diagnosis/screening exam 
and OMT techniques will last approximately 15-20minutes. 
vi. BEMER Protocol 
1. Subject will lay supine on the BEMER mat, and place the B.Pad® in 
their lower back.  BEMER mat intensity 3 will be selected in week 
1, intensity 4 for week 2, and intensity 5 for week 3.  B.Pad® will 
be set for Program 1 in week 1, Program 2 in week 2, and Program 
3 in week 3. Treatments last approximately 15-20 minutes. 
 
d. Description of Therapies used 
i. OMT  
1. Myofascial release (MFR) is a system of diagnosis and treatment 
which engages continual palpatory feedback to achieve release of 
myofascial tissues [33].MFR can be performed in a direct or 
indirect manner. If direct MFR is being performed the area of 
myofascial tissue restriction is engaged for the myofascial tissues 
and the tissue is loaded with a constant force until tissue release 
occurs. If indirect MFR is being performed the area of the body 
with dysfunctional myofascial tissues are guided along the path of 
least obstruction until free movement is achieved. For this study, 
the student doctors will perform MFR in the thoracic, lumbar and 
sacral regions with the patient lying on their back and on their 
stomach.  
2. Soft tissue (ST) is a system of diagnosis and treatment directed 
toward tissues other than bony or joint origins [33]. Soft tissue 
technique involves direct engagement of myofascial tissues and is 
applied with lateral stretching, linear stretching, deep pressure, 
traction and/or separation of muscle origin and insertion while 
monitoring tissue response and motion changes by palpation. Soft 
tissue techniques will be applied to the lumbar region in this 
study.  
3. Muscle energy (ME) is a form of osteopathic manipulative 
diagnosis and treatment in which the patient’s muscles are 
actively used on request, from a precisely controlled position, in a 

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specific direction, and against a distinctly executed physician 
counterforce [33]. The precisely directly muscle contraction from 
the subject, that is resisted equally by the treater, is proposed to 
increase tension on the Golgi tendon organ proprioceptors within 
a muscle [21]. Reflexively this will cause inhibition and subsequent 
increase in the muscle length within a hypertonic muscle [33]. 
This temporary increase in muscle length and relaxation are what 
the treater is monitoring  [33]. We will use muscle energy 
technique in the lumbar region in either the seated or lateral 
recumbent position in this study. 
4. Counterstrain (CS) technique is a system of diagnosis and 
treatment that considers the dysfunction to be a continuing, 
inappropriate muscle/tendon/ligament strain reflex, which is 
stopped by applying a position of mild strain in the direction 
exactly opposite to that of the reflex; this is accomplished by 
specific directed positioning about the point of tenderness to 
achieve the desired therapeutic response [33].  We will screen for 
counterstrain tenderpoints associated with psoas, quadratus 
lumborum, and piriformis muscles. These muscles have 
attachments to the lumbar spine, pelvis and the lower extremity 
and have been postulated to be a contributing factor to 
musculoskeletal causes of low back pain [34, 35]. Some of this 
techniques proposed mechanisms of action includes change in 
muscle spindle reflex, alpha Ia afferents and gamma efferent 
system with the corrective positioning [21, 33]. 
5. Balanced ligamentous tension (BLT) technique takes into account 
that all the joints in the body are balanced ligamentous articular 
mechanisms [21]. The ligaments provide somatosensory 
information that guides the muscle response for positioning the 
joint and the ligaments themselves guide the motion of the bony 
components. The goal of treatment is to balance the tension in 
contrasting ligaments where there is inappropriate tension 
present. BLT will be performed in the study in the lumbar, pelvis 
and sacrum. The common proposed mechanism of action for all 
the techniques used in the study include using the physiologic 
properties of connective tissue and the fascial continuum of the 
body to help relieve myofascial restrictions [21]. 
ii. Bio Electro-Magnetic Regulation (BEMER) Therapy 
1. BEMER is a therapeutic modality that deploys a biorhythmically 
defined stimulus through Pulsed Electromagnetic Field (PEMF).  
This stimulus has a targeted effect on the microvasculature, and 
the primary effect is an improvement in tissue microcirculation 
[3]. The positive effects of vasomotion on the microcirculation has 
been shown to result in significant increases in arteriovenous 

 8
oxygen difference, number of open capillaries, arteriolar and 
venular flow volume, and flow rate of red blood cells in the 
microvasculature [1, 2]. Therefore, BEMER can potentially be used 
in the treatment of LBP by improving microcirculation in muscular 
tissue. 
iii. Placebo (Light touch, and BEMER Sham): Treaters will place their hands 
lightly on the subject’s lumbar paraspinal muscles in the supine and 
prone positions in the same area as where one would place your hands 
for lumbar MFR technique for the same amount of time as it would take 
to perform MFR in this area (approximately 5 minutes).  However, no 
lifting or action will be done.  In addition, the subject will lie down on the 
BEMER mat (as they would do during a BEMER session), but the device 
will not be activated. This treatment will be used as a control.  
e. The research assistants will individually coordinate experimental times with the 
subjects.  A licensed osteopathic physician will be in the vicinity of the treatment 
location at all times while treatments are being given. 
f. OMT, BEMER, and placebo will be performed by osteopathic medical students 
who have completed additional training given by a licensed osteopathic 
physician to ensure uniform technique.  A licensed osteopathic physician will be 
in the vicinity of the treatment location at all times while treatments are being 
given. 
g. All data collection logs will be de-identified of personal information and only 
contain the randomized participant ID number linking the participant to the data 
collected. Thompson Fillmer, who is one of the research coordinators, will be the 
data analyst. 
h. The identifying information will be maintained by the principal investigator in a 
locked cabinet, which he alone has access to. 
 
II. 
Study Procedures and Timeline 
a. Study duration 
i. The study duration is three weeks.  The subjects will be required to have 
either OMT, BEMER, OMT+BEMER, or Placebo treatments during the 
course of the study.  Each subject in the OMT groups (i.e. OMT and 
OMT+BEMER) will receive treatment 3 times per week for a period of 3 
weeks. Subjects in the BEMER groups (i.e. BEMER and OMT+BEMER) will 
receive treatment 5 times per week for a period of 3 weeks. Finally, 
subjects in the Placebo group will receive the light touch and BEMER 
sham treatments at same intervals as the corresponding experimental 
groups. OMT, BEMER, and placebo treatments will be performed by 
osteopathic medical students who have completed additional training 
given by a licensed osteopathic physician, to ensure uniform technique. 
b. Recruitment:  

 9
i. LECOM-Bradenton faculty, staff, osteopathic medical, dental, pharmacy, 
and master’s students will be informed via email of the opportunity to 
participate in the research study and will be given contact information to 
confirm eligibility with a study coordinator (Appendix A). 
c. Experimental Sessions 
i. Following written consent (Appendix B), subjects will be given a 
randomized study ID number.  They will be randomized into their 
treatment group. 
ii. Each subject in the OMT groups (i.e. OMT and OMT+BEMER) will receive 
treatment 3 times per week for a period of 3 weeks. As previously 
mentioned, subjects in the BEMER groups (i.e. BEMER and OMT+BEMER) 
will receive treatment 5 times per week for a period of 3 weeks. Finally, 
subjects in the Placebo group will receive the light touch and BEMER 
sham treatments at same intervals as the corresponding experimental 
groups. OMT, BEMER, and placebo treatments will be performed by 
osteopathic medical students who have completed additional training 
given by a licensed osteopathic physician, to ensure uniform technique. 
All treatments will be performed during the span of three consecutive 
weeks.   
iii. Subjects will complete brief questionnaires regarding low back pain and 
quality of life before the beginning of study and will complete the same 
questionnaires following the completion of the three week treatment 
(Appendices C, D, E).  
III. 
Analysis 
a. Study Statistics 
i. Primary outcome variable 
1. Questionnaire ratings before and after treatments 
ii. Statistical plan including sample size justification and interim data 
analysis 
1. Paired T-tests ( N~10 subjects) to investigate the changes in low 
back pain after each treatment protocol. 
2. One-Way ANOVA to investigate any statistically significant 
differences between the means of each of the 4 experimental 
groups.   
iii. Early stopping rules 
1. Any adverse effect, as determined by the attending licensed 
osteopathic physician. No adverse effects are anticipated. 
b. Blinding 
i. All outcome analyses will be performed in a blinded fashion.  Subject 
survey and corresponding data will be de-identified and analyzed 
retrospectively by investigators with no exposure to the treatment 
sessions.  Doing so will eliminate bias associated with investigator self-
interest and ensure subject anonymity.  
IV. 
Drugs/Substances/Devices 

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a. Drugs will not be used in this trial.  Instead, subjects will be given osteopathic 
manipulative treatment, BEMER therapy, and placebo light touch. 
b. The device utilized is BEMER Pro set.  
 
Research Participants 
The target population is LECOM-Bradenton faculty, staff, osteopathic medical, dental, 
pharmacy, and master’s students who are currently experiencing low back pain. The study will 
not target participants from a vulnerable or at-risk population.  Our target population will be 
informed via email of the opportunity to participate in the research study and will be given 
contact information to confirm eligibility with a study coordinator. 
I. 
Inclusion 
a. LECOM-Bradenton faculty, staff and Students currently enrolled in LECOM-
Bradenton’s osteopathic medical program, pharmacy program, dental program, 
and master’s program who are currently experiencing low back pain will be 
approached for recruitment. 
II. 
Exclusion 
a. Subjects will be excluded if they are unable to provide informed consent, are 
currently pregnant, or have a known medical history of current 
i. Psychiatric conditions 
ii. Skin disorders or open wounds precluding skin contact 
iii. Fasciitis of fascial tears 
iv. Myositis 
v. Neurological symptoms such as numbness, tingling, weakness in lower 
extremities 
vi. Neoplasia 
vii. Cancer  
viii. Bone fracture, osteomyelitis, or osteoporosis 
ix. Coagulation problem 
x. Deep vein thrombosis 
xi. Adrenal diseases/syndromes 
xii. Acute upper or lower respiratory infection 
xiii. Immunosuppressive syndromes 
xiv. Radiation or chemotherapy within the past 3 years 
xv. Lupus 
xvi. Osteopenia 
xvii. Congestive heart failure 
xviii. BMI greater than 30  
xix. Any other autoimmune disease not stated above 
xx. Medication changes within the last 4 weeks  
xxi. Asthma exacerbations within the last 4 weeks  
xxii. Immunosuppressive therapy as a consequence of organ transplantation 
xxiii. Immunosuppressive therapy as a consequence of allogeneic cellular 
transplantations or bone marrow stem cell transplantation  

 11
xxiv. Other conditions often requiring immunosuppressive therapy 
xxv. Anticoagulant therapy  
xxvi. Known sensitivity to the carotid sinus reflex 
b. Subjects will be screened for eligibility based on the inclusion and exclusion 
criteria described above at the point of subject consent.  No protected health 
information will be collected from subjects who are not eligible to participate in 
the study. 
c. If subjects develop any of the above issues during the course of the study, they 
will be removed from the study without penalty and will still receive 
compensation. 
III. 
Definition of treatment failure or subject removal criteria 
a. Subjects who do not adhere to the full treatment regimen will be removed from 
the study. 
b. Subjects who experience any adverse effects from treatment, as determined by 
a licensed osteopathic physician, will be immediately removed from the study. 
However, we do not anticipate any adverse effects during the study.  
 
Risks and Benefits 
I. 
Risks 
a. Anticipated medical risks 
i. After OMT, muscle tenderness and generalized discomfort may be noted 
24-48 hours after treatment in a small number of patients. 
ii. There is little empiric data about the “hazards” to patients of student-
performed procedures. Further, this study does not employ any 
inherently forceful techniques. 
iii. There are no anticipated adverse effects associated with BEMER therapy. 
b. Steps taken to minimize the risks 
i. 
All Osteopathic Medical students performing osteopathic manipulation 
will receive additional special training by a licensed osteopathic 
physician, member of the LECOM-Bradenton OMM Department, and 
will disclose their true identity to the subjects to avoid any 
misconceptions that they are licensed physicians.  Student-treaters will 
be critiqued by a physician until they are approved to perform OMT on 
the subjects.  
ii. 
A licensed osteopathic physician will be in the vicinity of the treatment 
location at all times a treatment is being given. 
iii. 
The operation of the BEMER Pro Set will be done by students, who will 
be trained by a BEMER representative. The BEMER representative will 
ensure students are well trained in the operation of the device. In 
addition, the Principal Investigator will also be available during the 
training and throughout the study duration to assist the students.    
iv. 
There are no funds designated to compensate subjects for injury. The 
principal investigator will work with injured subjects to provide them 
with further information to the best of his ability 

 12
c. Plan for reporting adverse events 
i. All serious or unanticipated adverse events must be reported to the 
LECOM IRB promptly. 
ii. All protocol amendments will be submitted to IRB for approval, with the 
exception of changes that must be made in order to eliminate any 
imminent risk of harm to subjects or to others. In this circumstance, the 
investigator will act to eliminate the immediate risk but must 
subsequently submit an appropriate protocol amendment and await 
approval before proceeding with the revised protocol.   
  
  
 
 
II. 
Benefits 
a. Description of probable benefits 
i. Subjects may experience a decrease in low back pain. This can translate 
to healthy and natural ways to improve quality of living in patients with 
disabling low back pain. Individually, patients could see significant 
increases in quality of life. 
ii. With regards to society, this study could provide patients with an 
efficient and inexpensive way to alleviate many of the disabilities that are 
associated with living with low back pain.  
 
Consent Process and Privacy Protection 
I. 
Consent Process 
a. Participants will be introduced to the study through classroom announcements 
and recruitment emails.  If they decide to participate we will provide participants 
with a written informed consent form (Appendix B) for them to read.  In 
addition, a researcher will thoroughly explain the study to them to ensure that 
the subject is willing to participate in the experiment.  The participant will then 
sign the form after comprehension is assessed via verbal reiteration and 
opportunity has been provided for questions. 
II. 
Privacy Protection/Confidentiality 
a. Any document that can be identified with the participant including informed 
consent, emergency information, and project data will be stored in a locked filing 
cabinet in the principal investigator’s office.  It will remain confidential unless 
provided with the participant’s permission or required by law.  Three years after 
completion of the study, any personal identifiers (names, addresses, birth dates, 
phone numbers, etc.) will be destroyed. 
b. All participants will be given a numerical subject ID to ensure anonymity.  Both 
recorded and survey data will be labeled with study number only.  This ID will 
also be kept in the secured, locked filing cabinet, and only the Principal 
Investigator will have access to these documents.  The materials will be saved for 
three years and then shredded. 
c. Members of the research team have completed the required CITI training 
modules prior to working on the proposed research.  Identity unlinking 

 13
procedures and use of de-identified database ensure that results of surveys and 
patient demographics remain confidential. 
d. We will not be making any photograph, audio, or video recordings of participants 
without participant consent.   
e. Our study does not involve collection of data that might produce a regulatory 
mandate or duty to inform authorities about potentially harmful or illegal 
activities. 
f. Certification of Confidentiality and application for Federal Exemption to 
Reporting are unnecessary. 
Payment and Costs 
I. 
Payment 
a. All subjects will receive a compensation of $50 the form of a gift card for a local 
eating/shopping establishment at the time of completion of the study.   
b. Subjects who cannot complete the protocol due to adverse events will still be 
compensated. 
c. Subjects who are noncompliant with protocol will not receive compensation. 
d. No fees for participation 
e. No penalties for participation or non-completion 
II. 
Costs 
a. Payment to subjects:  
i. BEMER Pro Set: $5,990 
ii. 3 week compensation: $50 per individual (estimating 40) = $2,000 
b. Total = $7,990  
c. All paid by grants TBD 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 14
Appendices 
Appendix A: Recruitment email 
The LECOM Student American Academy of Osteopathy (SAAO), is conducting a 
study, and we would like to welcome all LECOM faculty, staff, and students to 
participate. The study will evaluate the individual and combine impact of osteopathic 
manipulative treatment (OMT) and Bio Electro-Magnetic Regulation (BEMER) Therapy 
on low back pain.   
This study will take place over a three-week period.  Each subject in the OMT 
group will receive treatment 3 times per week for a period of 3 weeks. Subjects in the 
BEMER groups will receive treatment 5 times per week for a period of 3 weeks. Each 
subject in the OMT+BEMER group will receive OMT 3 times per week and BEMER 
therapy 5 times per week for a period of 3 weeks. Subjects will complete brief 
questionnaires regarding low back pain and quality of life before the beginning of study 
and will complete the same questionnaires following the completion of the three week 
treatment. Each treatment will be individually scheduled with your assigned study 
coordinators. Each treatment session will last approximately 10-30 minutes.  You will be 
compensated with a $50 gift card for your time.   
If you are interested and would like to learn more about the study, please 
contact Kasey Coutinho (Study Coordinator) at KCoutinho11315@med.lecom.edu for 
more information. Thank you for your consideration in helping with this very important 
research. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 15
Appendix B: Consent Form 
 
CONSENT FORM for OMT Research Study  
LECOM – Bradenton 
 
Introduction 
You are invited to take part in a research study at LECOM-Bradenton. Researchers and medical 
students at LECOM-Bradenton are investigating the individual and combine effects of 
osteopathic manipulative treatment (OMT) and BEMER therapy on low back pain. Bio Electro-
Magnetic Regulation (BEMER) Therapy is a therapeutic modality that deploys very small electric 
pulses that cause blood vessels to open up, and leads to an increase in blood flow. You will not 
feel the electric pulses as they are very small. This study may yield information that will benefit 
future students and could extend benefits to other members of society, especially those with 
severe low back pain.  
 
Research Methods 
The length of the study is 3 weeks.  A sample of approximately 40 participants is anticipated.  If 
you decide to participate, you will be randomly assigned one of 4 treatments groups. 
Depending on the group you are assigned, you will receive OMT treatment 3 times per week for 
3 weeks, or BEMER therapy five times per week for 3 weeks, or both. Each subject in the 
OMT+BEMER group will receive OMT 3 times per week and BEMER therapy 5 times per week 
for a period of 3 weeks. All treatments will be performed during the span of three consecutive 
weeks.  You will complete brief questionnaires regarding low back pain and quality of life 
before the beginning of study and will complete the same questionnaires following the 
completion of the three week treatment. Each treatment session should last between 10-30 
minutes.  You will be assigned a study coordinator group in order to individually schedule your 
treatment sessions at your convenience. A licensed osteopathic physician will be available at all 
times a treatment is being given. The effectiveness of OMT and BEMER is considered 
experimental in the context of this study. 
 
All of your answers to the questionnaire and data collected during the treatment sessions will 
be entered electronically via a secure website and de-identified using your randomized study 
number. 
 
Confidentiality 
Your information will be kept confidential to anyone outside of the study. Individuals involved 
in the study include trained LECOM-Bradenton faculty and medical student research assistants. 
After we collect your survey and treatment results. Any document that can identify you, 
including a record of subject identification numbers will be kept in a locked filing cabinet in the 
PI’s office for three years. This de-identified information will be kept confidential to the extent 
legally possible.   
 
Subject Risks 

 16
All research studies have some degree of risk or discomfort. In this study, you may risk feeling 
slight discomfort during manipulative or standard treatment. Following the treatment, it is 
possible that you will feel some muscle tenderness or generalized discomfort 24-48 hours after 
the session. Much more rarely, more serious adverse effects include: substantial injury, 
excessive muscle soreness, loss of consciousness, vertigo, dizziness, shortness of breath, chest 
pain, and any type of numbness and tingling in arms, leg, or neck. If you experience any of 
these symptoms they should be brought to the attention of the supervising physician 
immediately. 
Your treatment will be performed by trained medical students, supervised by licensed 
osteopathic physicians. Medical students will disclose their true identity to avoid any 
misconception that they are licensed physicians. There is little empiric data about the “hazards” 
to patients of student-performed procedures. However, absence of confirmatory data does not 
mean that a risk does not exist. Considering students' inexperience, student-performed 
procedures would be expected to carry a higher risk of complication to patients (Marracino, MD 
& Orr, MD, 1998). After OMT therapy, muscle tenderness and generalized discomfort may be 
noted 24-48 hours after treatment in a small number of patients. There are no funds 
designated to compensate subjects for injury. The principal investigator will work with injured 
subjects to provide them with further information to the best of his ability.  
 
There are no anticipated adverse effects associated with BEMER therapy.   
 
There could be a potential risk of loss of privacy or confidentiality if an unauthorized person 
gained access to the sample data. However, we believe that the security measures taken in the 
study protocol make it highly unlikely that such an event would occur. Additionally, some risks 
to the subject (or to the fetus/embryo if the subject is or may become pregnant) are currently 
unforeseeable. 
 
Although OMT and BEMER therapy may be helpful in alleviating low back pain, there are 
several alternative treatments such as medications, physical therapy, massage therapy, and 
acupuncture. Any significant new findings developed during the course of research that may 
relate to your willingness to continue participation in the study will be provided to you. 
 
Benefits 
 
Subjects may experience a decrease in low back pain. This can translate to healthy and natural 
ways to improve quality of living in patients with disabling low back pain. Individually, patients 
could see significant increases in quality of life. 
With regards to society, this study could provide patients with an efficient and inexpensive way 
to alleviate many of the disabilities that are associated with living with low back pain.  
 
Voluntary Consent 
 
You may choose to participate or may choose not to participate. If you choose not to 
participate in this study there will be no penalty or loss of benefits to which you are otherwise 

 17
entitled. If you choose to participate in this study you may withdraw from further participation 
at any time by contacting the Principal Investigator. If you withdraw, there will be no penalty or 
loss of benefits to which you are otherwise entitled. Your participation will not provide any 
benefit/negative impact with respect to your status at LECOM.   
 
Compensation 
Should you choose to participate, you will be compensated for your time with a $50 gift 
certificate after the successful completion of your final treatment session. If you consent to the 
study but do not attend all treatment sessions or fail to complete all survey questions, the 
principal investigator will terminate your participation and you will not receive compensation. 
 
Eligibility 
Interested volunteers are not eligible to participate if currently pregnant as the procedure may 
involve risks to the unborn fetus or embryo. Additional exclusion criteria include any individual 
who has a current medical history of: 
• Psychiatric conditions 
• Skin disorders or open wounds precluding skin contact 
• Fasciitis of fascial tears 
• Myositis 
• Neurological symptoms such as numbness, tingling, weakness in lower extremities 
• Neoplasia 
• Cancer  
• Bone fracture, osteomyelitis, or osteoporosis 
• Coagulation problem 
• Deep vein thrombosis 
• Adrenal diseases/syndromes 
• Acute upper or lower respiratory infection 
• Immunosuppressive syndromes 
• Radiation or chemotherapy within the past 3 years 
• Lupus 
• Osteopenia 
• Congestive heart failure 
• BMI greater than 30  
• Any other autoimmune disease not stated above 
• Medication changes within the last 4 weeks  
• Asthma exacerbations within the last 4 weeks  
• Immunosuppressive therapy as a consequence of organ transplantation 
• Immunosuppressive therapy as a consequence of allogeneic cellular transplantations or 
bone marrow stem cell transplantation  
• Other conditions often requiring immunosuppressive therapy 
• Anticoagulant therapy 
• Known sensitivity to the carotid sinus reflex 
 

 18
If you develop any of these issues during the course of the study, you will be removed from the 
study without penalty and still receive compensation. 
 
References 
Marracino, MD, R. K., & Orr, MD, R. D. (1998). Entitling the student doctor. J Gen Intern 
Med , 13 (4), 266-270. Retrieved from 
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1496940/ 
 
If you have questions about the research or incur a research related injury, please contact: 
Santiago Lorenzo, Ph.D., M.S., M.S. (Med Ed) 
Phone: (941) 782-5974 
Email: slorenzo@lecom.edu 
 
If you have any questions about the research study contact: 
Kasey Coutinho, Study Coordinator  
Phone: (321) 246-1195 
Email: KCoutinho11315@med.lecom.edu 
 
 
 
If you have questions about your rights as a research subject, please contact 
Irv Freeman, PhD., J.D., Chair, LECOM Institutional Review Board 
Phone: (724) 552-2870 
E-mail: ifreeman@lecom.edu 
_____________________________________________________  
 
____________ 
Signature of Subject  
 
 
 
 
 
 
 
Date 
 
 
_____________________________________________________  
 
____________ 
Signature of Study Coordinator 
 
 
 
 
 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 

 19
Appendix C:  
SF-12 Health Survey 
 
 
SF-12 HEALTH SURVEY (STANDARD) 
 
 
INSTRUCTIONS:  This questionnaire asks for your views about your health.  This information will help 
keep track of how you feel and how well you are able to do your usual activities. 
 
Please answer every question by marking one box.  If you are unsure about how to answer, please give 
the best answer you can. 
 
 
1. In general, would you say your health is: 
 
 
 
          
 
   
 
  
 
   
 
Excellent  
Very good 
 
Good  
Fair 
 
Poor 
 
 
The following items are about activities you might do during a typical day.  Does your health now limit 
you in these activities?  If so, how much? 
 
 
 
 
 
 
 
 
Yes, 
 
Yes, 
 
No, Not 
 
 
 
 
 
 
Limited 
Limited 
Limited 
 
 
 
 
 
 
A Lot  
A Little 
At All 
 
2.  Moderate activities, such as moving    
  
 
    
 
    
     a table, pushing a vacuum cleaner, 
 
 
     bowling or playing golf 
 
3.  Climbing several flights of stairs   
  
 
 
    
 
   
 
 
During the past 4 weeks, have you had any of the following problems with your work or other regular 
daily activities as a result of your physical health? 
 
 
 
 
 
 
 
 
 
Yes 
 
No 
 
4.  Accomplished less than you would like 
 
 
 
 
 
 
 
 
 
5.  Were limited in the kind of work or other activities   
 
 
 
 
 
 
 

 20
 
 
During the past 4 weeks,  have you had any of the following problems with your work or other regular 
daily activities as a result of any emotional problems (such as feeling depressed or anxious)? 
 
 
 
 
 
 
 
 
 
 
Yes 
 
No 
 
6.  Accomplished less than you would like 
 
 
 
 
 
 
7. Didn’t do work or other activities as carefully 
 
 
 
 
as usual 
 
 
8. During the past 4 weeks, how much did pain interfere with your normal work 
      (including both work outside the home and housework)? 
 
 
 
                
 
   
 
     
 
       
 
     Not at all 
      A little bit           Moderately         Quite a bit           Extremely 
 
 
These questions are about how you feel and how things have been with you during the past 4 weeks.  For 
each question, please give the one answer that comes closest to the way you have been feeling.  How 
much of the time during the past 4 weeks – 
 
All 
     Most     
A Good           Some 
      A Little 
None 
of the        of the  
Bit of             of the          of the 
of the 
Time      Time 
the Time          Time 
      Time 
Time 
 
 
 
 
 
9.   Have you felt 
   
            
     
 
  
         
 
  
      calm and peaceful?  
 
 
10.  Did you have a       
       lot of energy?  
   
            
     
 
  
         
 
  
 
11. Have you felt 
   
downhearted and  
blue? 
 
   
            
     
 
  
         
 
  
 
12. During the past 4 weeks, how much of the time has your physical health or emotional problems 
interfered with your social activities (like visiting with friends, relatives, etc.)? 
 
 
  
              
     
 
     
                  
    
 
All of 
Most of         A Good Bit 
Some of     
  A little of               None 
       the time     the time          of the time 
the time    
  the time 
      the time 
 

 21
Appendix D: 
 
Visual Analog Scale                 
 
The Visual Analog Scale (VAS) is a 100-millimeter line with “no pain” on one end and 
“pain as bad as it can be” at the other end. This scale is a very simple form of 
assessment. Patients are expected to mark on the line the amount of pain they are 
experiencing.  
 
     
 
|___________________________________________________________| 
No pain                                                                                               Pain as bad as it 
                                                                                                           could possibly be  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 22
Appendix E: 
Oswestry low back pain questionnaire 
Instructions  
This questionnaire has been designed to give us information as to how your back or leg pain 
is affecting your ability to manage in everyday life. Please answer by checking ONE box in 
each section for the statement which best applies to you. We realise you may consider that 
two or more statements in any one section apply but please just shade out the spot that 
indicates the statement which most clearly describes your problem. 
section 1 - pain intensity 
section 6 - standing 
 I can tolerate the pain I have without having to use pain 
 I can stand as long as I want without extra pain 
killers 
 I can stand as long as I want but it gives me extra pain 
 the pain is bad but I manage without taking pain killers 
 pain prevents me from standing for more than 1 hour 
 pain killers give complete relief from pain 
 pain prevents me from standing for more than 1/2 hour 
 pain killers give moderate relief from pain 
 pain prevents me from standing for more than 10 minutes 
 pain killers give very little relief from pain 
 pain prevents me from standing at all 
 pain killers have no effect on the pain and I do not use them 
 
 
section 7 - sleeping 
section 2 - personal care (washing, dressing, etc) 
 pain does not prevent me from sleeping well 
 I can look after myself normally without causing extra pain 
 I can sleep well only by using tablets 
 I can look after myself normally but it causes extra pain 
 even when I take tablets I have less than six hours sleep 
 it is painful to look after myself and I am slow and careful 
 even when I take tablets I have less than four hours sleep 
 I need some help but manage most of my personal care 
 even when I take tablets I have less than two hours sleep 
 I need help every day in most aspects of self care 
 pain prevents me from sleeping at all 
 I do not get dressed, wash with difficulty and stay in bed 
 
 
section 8 - sex life 
section 3 - lifting 
 my sex life is normal and causes no extra pain 
 I can lift heavy weights without extra pain 
 my sex life is normal but causes some extra pain 
 I can lift heavy weights but it gives extra pain 
 my sex life is nearly normal but is very painful 
 pain prevents me from lifting heavy weights off the floor, 
 my sex life is severely restricted by pain 
but I can manage if they are conveniently positioned, eg on 
 my sex life is nearly absent because of pain 
a table 
 pain prevents any sex life at all 
 pain prevents me from lifting heavy weights but I can 
 
manage light to medium weights if they are conveniently 
section 9 - social life 
positioned 
 my social life is normal and gives me no extra pain 
 I can lift only very light weights 
 my social life is normal but increases the degree of pain 
 I cannot lift or carry anything at all 
 pain has no significant effect on my social life apart from  
 
  
limiting my more energetic interests, eg dancing etc 
section 4 - walking 
 pain has restricted social life and I do not go out as often 
 pain does not prevent me walking any distance 
 pain has restricted my social life to my home 
 pain prevents me walking more than 1 mile 
 I have no social life because of pain 
 pain prevents me walking more than 1/2 mile 
 
 pain prevents me walking more than 1/4 mile 
section 10 - travelling 
 I can only walk using a stick or crutches 
 I can travel anywhere without extra pain 
 I am in bed most of the time and have to crawl to the toilet 
 I can travel anywhere but it gives me extra pain 
 
 pain is bad but I manage journeys over two hours 
section 5 - sitting 
 pain restricts me to journeys of less than one hour 
 I can sit in any chair as long as i like 
 pain restricts me to short necessary journeys of less than 
 I can only sit in my favourite chair as long as i like 
  
1/2 hour 
 pain prevents me from sitting more than 1 hour 
 pain prevents me from travelling except to the doctor 
 pain prevents me from sitting more than 1/2 hour 
  
or hospital 
 pain prevents me from sitting more than 10 minutes 
from:  Fairbank J C T, Couper J, Davies J B & O'Brien J P 
 pain prevents me from sitting at all 
                    Physiotherapy 1980; 66: 271-73 

 23
 
 
Research Roles and Support Documentation 
All research project personnel, unless otherwise noted have completed, within the past two 
years, the on-line CITI training appropriate to their roles.  Documentation of which are attached 
to this proposal. 
a. Principal Investigator 
i. Santiago Lorenzo, Ph.D., M.S., M.S. (Med Ed) CITI expiration: 01/03/2021 
b. Co-Investigator  
i. Nicole E. Myers, DO, MS 
                          CITI expiration: 05/07/2021 
ii. Thomas Quinn, DO  
 
 
 
CITI expiration: 05/10/2021 
c. Graduate Student Researchers 
i. Study Coordinator: responsible for consenting patients and maintaining 
study protocol 
1. Kasey Coutinho 
 
 
CITI expiration: 05/20/2021 
ii. Research coordinators: responsible for coordination, patient scheduling, 
maintaining study database, treatment administration, data collection, 
and study adherence 
1. Kyle Herout 
 
 
 
CITI expiration: 05/14/2021 
2. Thompson Fillmer 
 
 
CITI expiration: 05/16/2021 
3. Kyle Auger  
 
 
 
CITI expiration: 05/15/2021 
4. Gregory Shedlock 
 
 
CITI expiration: 05/16/2021 
 
CITI Program Certificates 
COLLABORATIVE INSTITUTIONAL TRAINING INITIATIVE (CITI PROGRAM) 
 
 
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Klopp, R.C., W. Niemer, and J. Schulz, Complementary-therapeutic stimulation of 
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