Photobiomodulation Therapy on Low Back Pain

Study Overview
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Brief Summary
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Photobiomodulation therapy (PBMT) is a non-pharmacological method commonly used in treatment of musculoskeletal disorders. However, there are few high-quality scientific evidence to support the effectiveness of this therapy in the treatment of patients with chronic low back pain, at short, medium and long term. The present research project aims to evaluate the effects of PBMT in patients with chronic non-specific low back pain.

Detailed Description
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This is a randomized, triple-blinded, placebo-controlled trial, with voluntary patients with chronic non-specific low back pain.One hundred and forty-eight patients will be randomly allocated to two treatment groups: Placebo or PBMT for 4 weeks (3 times per week, total of 12 sessions of 27 minutes each). The clinical outcomes will be obtained at the completion of treatment (4 weeks) and at 3, 6 and 12 months after randomization. The data will be collected by a blinded assessor. The statistical analysis will follow the intention-to-treat principles and the between-group differences will be calculated by using mixed linear models. The outcomes of interest are pain intensity, disability, function and global perceived effect.

Official Title
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Effects of Photobiomodulation Therapy in Patients With Chronic Non-specific Low Back Pain: a Randomized Placebo-controlled Trial

Conditions
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Low Back Pain

Intervention / Treatment
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* Device: Placebo PBMT
* Device: PBMT active


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients seeking care for chronic non-specific low back pain (defined as pain or discomfort between the costal margins and the inferior gluteal folds, with or without referred symptoms in the lower limbs, for at least 3 month); with a pain intensity of at least 3 points measured by a 0-10 points pain numerical rating scale; aged between 18 and 65 years; able to read Portuguese. Exclusion Criteria: evidence of nerve root compromise (i.e. one or more of motor, reflex or sensation deficit); serious spinal pathology (such as fracture, tumor, inflammatory and infectious diseases); serious cardiovascular and metabolic diseases; previous back surgery; pregnancy.

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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo PBMT<br>Application of PBMT (Photobiomodulation Therapy) without any dose (0 Joule) and The Back Book (educational information booklet). | Device: Placebo PBMT<br>* The PBMT treatments will be performed using the Multi Radiance Medical™ Super Pulsed Laser MR4™ console (Solon, OH, USA), with the LS50 (emitter with an area of 20 cm2) and SE25 (emitter with an area of 4 cm2) cluster probes as emitters. Nine sites will be irradiated at patient's lumbar region: 3 central sites, using the SE25 (without any dose, 0 J); and 6 sites in the same direction, but laterally (both sides, 3 at a side), using the LS50 (without any dose, 0 J). Patients will be treated during 12 sessions over a period of four weeks (three sessions/week). At each treatment session, patients will receive a total dose of 0 J. At the end of the 12 treatment sessions, patients will receive a total dose of 0 J.<br>|
| Active Comparator: PBMT active<br>Application of PBMT (Photobiomodulation Therapy) active and The Back Book (educational information booklet). | Device: PBMT active<br>* The PBMT treatments will be performed using the Multi Radiance Medical™ Super Pulsed Laser MR4™ console (Solon, OH, USA), with the LS50 (emitter with an area of 20 cm2) and SE25 (emitter with an area of 4 cm2) cluster probes as emitters. Nine sites will be irradiated at patient's lumbar region: 3 central sites, using the SE25 (3000 Hz of frequency, 3 minutes of irradiation per site, 24.75 J per site, a totalizing 74.25 J irradiated from SE25); and 6 sites in the same direction, but laterally (both sides, 3 at a side), using the LS50 (1000 Hz of frequency, 3 minutes of irradiation per site, 24.30 J per site, a total of 145.80 J irradiated from LS50). Patients will be treated during 12 sessions over a period of four weeks (three sessions/week). At each treatment session, patients will receive a total dose of 220.05 J. At the end of the 12 treatment sessions, patients will receive a total dose of 2640.60 J.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity | Pain intensity will be measured by an 11-point (0-10) Numerical Rating Scale (Pain NRS) | 4 weeks after randomization | 
| Disability | Disability will be measured by the 24-item Roland Morris Disability Questionnaire | 4 weeks after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Pain intensity will be measured by an 11-poin (0-10) Numerical Rating Scale (Pain NRS) | 3, 6 and 12 months after randomization | 
| Disability | Disability will be measured by the 24-item Roland Morris Disability Questionnaire | 3, 6 and 12 months after randomization | 
| Function | Function will be measured by an 11-point (0-10) Patient-Specific Functional Scale | 4 weeks, 3, 6 and 12 months after randomization | 
| Global perceived effect | Global perceived effect will be measured by an 11-point (-5 to +5) Global Perceived Effect Scale | 4 weeks, 3, 6 and 12 months after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low back pain, photobiomodulation therapy, LLLT