Photobiomodulation Therapy (PBMT) in Patients With Low Back Pain (LBP)

Study Overview
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Brief Summary
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Low back pain (LBP) is a highly prevalent condition worldwide and the leading cause of years lived with disability. In most cases, the specific pathological cause remains unidentified; therefore, the term non-specific low back pain is commonly used for such cases. Many non-pharmacological therapies are available for the treatment of low back pain aiming to reduce pain and disability. Among these options, photobiomodulation therapy (PBMT) it seems to be an interesting alternative. PBMT is a non-thermal and non-invasive clinical treatment, which has shown effects in decreased pain, modulation of inflammatory process, and tissue repair in musculoskeletal disorders. Therefore, the aim of this project is to evaluate the effects of the PBMT against placebo on pain intensity in patients with chronic non-specific low back pain.

Detailed Description
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To achieve the proposed objective, it will be performed a randomized, triple-blind (patients, therapists, and outcome assessors), placebo-controlled trial. Seventy-two patients with chronic non-specific low back pain will be randomly allocated to two treatment groups: 1. Active PBMT or Placebo PBMT. In both groups, six treatment sessions will be performed twice a week (at the same time of the day), with intervals of three or four days between sessions, during three-week period. The patients will be treated by a blinded therapist. The outcomes will be obtained at stabilization phase (during 2 weeks), baseline, end of treatment, 24, 48 and 72 hours after the last treatment session, and 7 days after conclusion of treatment. The data will be collected by a blinded assessor. Statistical analyzis: The Fischer's Exact Test will be conducted to compare the proportion of successes between groups. The Unpaired t-test will be used for demographic data. Repeated measures ANOVA will be performed to analyze pain intensity. The level of statistical significance will be set at p<0.05.

Official Title
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Effects of Photobiomodulation Therapy (PBMT) on Pain Intensity in Patients With Low Back Pain (LBP)

Conditions
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Low Back Pain

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with chronic non-specific low back pain, with symptoms present for at least three months; Patients with a pain intensity of at least 50mm (measured by a 0-100 mm Visual Analog Scale); Exclusion Criteria: Serious spinal pathologies (such as fractures, tumors, inflammatory, and infectious diseases); Patients who used local corticosteroids and/or botulin toxin injection for pain relief within the prior 30 days of the beginning of the study; Chronic pain diseases as fibromyalgia and diabetic type 1; Neuropathic pain; Previous spinal surgery in the past 12 months; Cancer patients; Pregnancy or breast feeding.

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Experimental: Active PBMT<br>Active PBMT will be performed twice a week (at the same time of the day), with intervals of three or four days between sessions, during three-week period (a total of 6 sessions). | Device: Active PBMT<br>* Active PBMT will be applied using a device with 152 emitters (wavelength - 808 nm; dose - 3000 J; treatment time - 600 s), in the low back region.<br>|
| Placebo Comparator: Placebo PBMT<br>Placebo PBMT will be performed twice a week (at the same time of the day), with intervals of three or four days between sessions, during three-week period (a total of 6 sessions). | Device: Placebo PBMT<br>* The placebo PBMT will be applied using the same device as that of active PBMT but without any emission of therapeutic dose. Moreover, the irradiated site and the irradiation time were the same as that of active PBMT. Patients received a total dose of 0 J in the placebo mode. The sounds and signals emitted from the device as well as the information displayed on the screen will be identical, regardless of the type of treatment (active or placebo).<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 0-100 standardized Visual Analog Scale (VAS). | 3 weeks (end of treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject satisfaction | Subject satisfaction will be measured by scale uses the following responses: very satisfied, somewhat satisfied, neither satisfied nor dissatisfied, not very satisfied or not at all satisfied. | 3 weeks (end of treatment). | 
| Control of concomitant medication intake | The control of concomitant medication intake will be measured by a individualized pain management diary. | 3 weeks (end of treatment). | 
| Pain intensity | Pain intensity will be measured by 0-100 standardized Visual Analog Scale (VAS). | 24 hours, 48 hours, and 72 hours after the last treatment session, and 7 days after conclusion of treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Photobiomodulation Therapy