The Effect of High Intensity Laser on Muscle Quality and Pain in Those With Low Back Pain

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effects of CureWave laser on paraspinal muscle oxygenation, pressure pain thresholds, muscle edema, and quality, and perceived outcomes in patients with chronic low back pain.

Detailed Description
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Low back pain (LBP) contributes to disability and has a significant economic impact. High intensity laser devices are class 4 producing > 40 W of power at longer wavelengths, thereby allowing deeper tissue penetration. Currently, there is little evidence to demonstrate the effectiveness of high intensity laser treatment in those with chronic LBP. Optimal dosing strategies are still unknown as well as patient response based on chronicity of symptoms. Therefore, our study seeks to evaluate the effectives of high intensity laser therapy using CureWave in those with LBP of a duration longer than 3 months and with a dosing strategy of two times/week for three weeks. Hypothesis CureWave laser therapy will increase total oxygenated hemoglobin and muscle blood flow in patients with chronic LBP. CureWave laser therapy will reduce inflammation as assessed by muscle edema in patients with chronic LBP. CureWave laser therapy will improve paraspinal echogenicity (muscle quality) following treatment in patients with chronic LBP. CureWave laser therapy will decrease muscle sensitivity in patients with chronic LBP CureWave laser therapy will demonstrate improve patient reported outcomes, including decreased pain, reduced disability and improved function in patients with chronic LBP. CureWave laser therapy will increase muscle activation during maximal strength testing. CureWave laser therapy will decrease performance fatigability as assessed by maximal muscle activation and force production.

Official Title
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The Effects of CureWave Laser on Paraspinal Muscle Oxygenation, Pressure Pain Thresholds, Muscle Edema, Muscle Quality, and Perceived Outcomes in Patients With Chronic Low Back Pain.

Conditions
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Low Back Pain

Intervention / Treatment
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* Device: CureWave High Intensity Laser
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-65 Self-reported history of low back pain (5 episodes in lifetime or 3 in last three years which altered activities of daily living)13 Exclusion Criteria: Self-reported pregnancy Inability to complete all required meeting sessions Known cardiovascular, pulmonary, metabolic, muscular, and/or coronary heart disease Regularly uses prescription medication Seeking medical care for the current episode of low back pain Report average symptoms greater than 8/10 Inability to perceive light touch. Verbal reports of known cardiovascular, pulmonary, metabolic, muscular, and/or coronary heart disease Verbal reports of known skin sensitivity to gels or adhesives.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Clinical Trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CureWave High Intensity Laser<br>The participant will lie prone and the HILT will be administered in two preliminary test locations. In order to evaluate any possible adverse reactions, the initial treatment location will be delivered at a decreased intensity at two separate locations above the target treatment areas. The Power for these two locations will be at a half dose (22 W) for one minute each. The initial, half dose treatment area is indicated by the Blue circles in the image below. Upon conclusion of the initial test treatments (at half dose), the skin with be evaluated for excessive redness or any other changes in skin appearance. Also, the participant will be asked about any discomfort. Should no unanticipated changes in skin appearance occur and the participant reports no discomfort, the treatment will be administered. The process of applying the laser at half dosage will occur prior to each treatment. | Device: CureWave High Intensity Laser<br>* The participant will lie prone and the HILT will be administered in 9 symmetrical positions which cover the lumbosacral region. Dose will be 1minute per position. The dose will include: Power (44 Watts) Mode (continues wave) Time on (60000 ms) Time off (1 ms) Repeats (9) Distance of electrode from skin will begin 10 from skin surface. The participant may or may not feel mild warmth. Should the subject report excessive warmth or discomfort the probe distance will be increased in 2 intervals until it is comfortable. The entire process will take approximately 10 minutes. The participant will lie prone and the Placebo treatment will consist of positioning the HILT probe over the 9 symmetrical positions for 1 minutes each however the no laser will be admitted.<br>|
| Placebo Comparator: Control<br>The participant will lie prone and the Placebo HILT will be administered is the same capacity as the treatment group however no Laser treatment will be administered. Upon conclusion of the placebo treatment, the skin with be evaluated for excessive redness or any other changes in skin appearance. Also, the participant will be asked about any discomfort. | Other: Placebo<br>* The participant will lie prone and the NON ACTIVE HILT will be administered in 9 symmetrical positions which cover the lumbosacral region. Dose will be 1minute per position. THE LASER WILL NOT BE ACTIVE. o Distance of electrode from skin will begin 10 from skin surface. The entire process will take approximately 10 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CHANGE in EMG activity of the lumbar paraspinal muscles | EMG will be recorded during all submaximal and maximal strength testing. EMG will be assessed using wireless Bluetooth electrodes that will be attached using double-sided adhesive stickers. All submaximal and maximal strength testing will be performed using a hand-held dynamometer (Microfet 2 Manual Muscle Tester). Subjects will be stabilized using a nylon strap, the same material and mechanism as a seat belt, when necessary to eliminate accessory or compensatory motion during strength testing. This will be placed on their anterior and/or medial thigh with padding to eliminate any discomfort where the strap contacts the skin. | Baseline; 24-48 hours after baseline; 4 weeks after baseline | 
| CHANGE in total hemoglobin | Change in total hemoglobin will be used as an index of change in regional blood volume.will be assessed using near-infrared spectroscopy (NIRS) (Portamon, Artinis Medical Systems, Arnhem, The Netherlands). | Baseline; 24-48 hours after baseline; 4 weeks after baseline | 
| CHANGE in Muscle Edema | Muscle edema will be assessed via ultrasound using the echo intensity function. Ultrasound images will be obtained using a portable brightness mode (B-mode) ultrasound-imaging device (GE Logiqe, USA) and a multi-frequency linear-array probe (12L-Rs; 5-13MHz; 38.4 mm field-of-view). Ultrasound images will be analyzed using ImageJ software (Version 1.47v., National Institutes of Health, Bethesda, MD, USA). Echo intensity, as assessed by gray-scale analysis (0 arbitrary units [AU], corresponds to black image, 255 AU corresponds to white image) will be performed using the histogram function and will be determined from the same region of interest as muscle thickness. | Baseline; 24-48 hours after baseline; 4 weeks after baseline | 
| CHANGE in Muscle sensitivity | Muscle sensitivity will be measured with a handheld digital algometer (Wagner FDX-25 pressure algometer- Wagner Instruments, Greenwich, CT) and be applied at a right angle to the skin surface with the subject lying in prone position at 3 locations on the Paravertebral muscles, Quadratus lumborum, and Piriformis. Pressure will be applied at a rate of 30 kPa/s, which corresponds to 3 N/s. | Baseline; 24-48 hours after baseline; 4 weeks after baseline | 
| CHANGE in Numeric Pain Rating Scale | Quantity of perceived Pain will be evaluated via a likert scale between 0 (no pain) to 10 (the worst imaginable pain) | Baseline; 24-48 hours after baseline; 4 weeks after baseline | 
| CHANGE in Muscle Oxygenation | Muscle oxygenation will be assessed using near-infrared spectroscopy (NIRS) (Portamon, Artinis Medical Systems, Arnhem, The Netherlands). Changes in muscle tissue oxygenation and deoxyhemoglobin will be examined across time using the optical densities from two continuous wavelengths (760 and 850 nm) | Baseline; 24-48 hours after baseline; 4 weeks after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CHANGE in Oswestry Disability Index | Measure self reported perceived disability via a standardized survey form that can report a raw score between 0 and 50 points. | Baseline; 24-48 hours after baseline; 4 weeks after baseline | 
| CHANGE in Patients Specific Functional Scale | Measure self reported functional abilities based on a survey form which identifies 5 individual functional tasks that the participant struggles with. These are rated 0 (no difficulty) to 10 (unable to perform task). | Baseline; 24-48 hours after baseline; 4 weeks after baseline | 
| CHANGE in Global Rating of Change | Measure overall change in condition via a survey questionnaire which rates change in symptoms between -7 (quite a bit worse) to 0 (no change) to +7 (quite a bit better). | Baseline; 24-48 hours after baseline; 4 weeks after baseline | 
| CHANGE in Sleep disturbance (short form 8a) | Measure self reported measures of sleep quality via a survey questionnaire that evaluates quality and quantity of sleep. | Baseline; 24-48 hours after baseline; 4 weeks after baseline | 
| CHANGE in International Physical Activity Questionnaire (IPAQ) | Measure of self reported physical activity via a survey questionnaire that reports level of physical activity. | Baseline; 24-48 hours after baseline; 4 weeks after baseline | 
| CHANGE in McGill Pain Questionnaire | Measure of pain quality via a survey questionnaire the measures qualitative aspects of perceived pain. | Baseline; 24-48 hours after baseline; 4 weeks after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laser, low back pain, Perceived Pain, Perceived Disability