PBMT Associated With MCE for Chronic Non- Specific Low Back Pain

Study Overview
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Brief Summary
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Non-specific low back pain (LBP) is a very prevalent health condition and is highly associated with disability worldwide. There is evidence that patients with non-specific LBP may have impairments in the control of postural muscles. In this way, motor control exercises (MCE) may be an interesting alternative in the treatment of patients with non-specific LBP. In addition, the association of MCE and photobiomodulation therapy (PBMT) may potentiate its benefits, since PBMT has ergogenic effects. Therefore, the aim of this study is to evaluate the ergogenic effects of PBMT, using low-level laser therapy, when associated with MCE in patients with chronic non-specific low back pain.

Detailed Description
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This is a randomized, triple-blind (patients, therapists, outcome assessors), 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 PBMT associated with MCE or Active PBMT associated with MCE. Treatment will be performed twice a week (on non-consecutive days), for 6 weeks, yielding 12 treatment sessions. Placebo PBMT or Active PBMT will be applied before the MCE protocol. The clinical outcomes will be obtained at the end of treatment (6 weeks), one month after the end of treatment, 3, 6 and 12 months after randomization. The biochemical outcome will be obtained only after the end of treatment. The remaining outcomes will be obtained after the end of treatment, one month after the end of treatment, 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 using two-way repeated measures ANOVA. The project was also approved by the Research Ethics Committee from Universidade Nove de Julho, under the number 5.289.714. Board Affiliation: Comissão Nacional de Ética em Pesquisa (CONEP) Phone: +55113385-9010 - Email: comitedeetica@uninove.br Address: Vergueiro nº 235/249. Liberdade, Sao Paulo, Sao Paulo, Brazil

Official Title
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Effects of Photobiomodulation Therapy (LASER) Associated With Motor Control Exercises for Chronic Non-specific Low Back Pain

Conditions
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Low Back Pain

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


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); patients with severe skin diseases (eg, skin cancer, erysipelas, severe eczema, severe dermatitis, severe psoriasis and severe hives lupus); decompensated severe cardiovascular and metabolic diseases; previous back surgery; patients with cancer; body mass index (BMI) ≥ 30. 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 + MCE<br>Placebo photobiomodulation therapy (PBMT), with a dose of 0 J, will be applied before a protocol of motor control exercises (MCE). | Device: Placebo PBMT + MCE<br>* Placebo PBMT will be irradiated at 4 sites in the lumbar region and 6 sites in the patient's abdominal region, without any emission of therapeutic dose. After, the patient will be submitted to a MCE protocol consisting on stabilization exercises and isometric abdominal training. The treatment will be performed twice a week (on non-consecutive days), for 6 weeks, yielding 12 treatment sessions.<br>|
| Active Comparator: Active PBMT + MCE<br>Active photobiomodulation therapy (PBMT), with a dose of 30 J, will be applied before a protocol of motor control exercises (MCE). | Device: Active PBMT + MCE<br>* Active PBMT will be irradiated at 4 sites in the lumbar region and 6 sites in the patient's abdominal region, with a dose of 30 J per site. After, the patient will be submitted to a MCE protocol consisting on stabilization exercises and isometric abdominal training. The treatment will be performed twice a week (on non-consecutive days), for 6 weeks, yielding 12 treatment sessions.<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 Pain Numerical Rating Scale that evaluates pain intensity levels perceived by the patient on an 11-point scale ranging from 0 to 10, with 0 being 'no pain' and 10 'the worst possible pain'. Higher scores mean worse outcome. | At the end of treatment (6 weeks after randomization) | 
| Disability | Disability will be measured by the 24-item Roland Morris Disability Questionnaire. The questionnaire consists of 24 items that patient has to answer 'yes' or 'no'. The minimum value is 0 and the maximum value is 24. Higher scores mean worse outcome. | At the end of treatment (6 weeks after randomization) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Pain intensity will be measured by Pain Numerical Rating Scale that evaluates pain intensity levels perceived by the patient on an 11-point scale ranging from 0 to 10, with 0 being 'no pain' and 10 'the worst possible pain'. Higher scores mean worse outcome. | 1 month after the end of the treatment, 3, 6 and 12 months after randomization | 
| Disability | Disability will be measured by the 24-item Roland Morris Disability Questionnaire. The questionnaire consists of 24 items that patient has to answer 'yes' or 'no'. The minimum value is 0 and the maximum value is 24. Higher scores mean worse outcome. | 1 month after the end of the treatment, 3, 6 and 12 months after randomization | 
| Levels of prostaglandin E2 (PGE2) | Levels of PGE2 will be measured by blood samples | At the end of treatment (6 weeks after randomization) | 
| Medication intake | The medication intake will be measured from self-report | At the end of treatment (6 weeks after randomization), 1 month after the end of treatment, 3, 6 and 12 months after randomization | 
| Co-interventions | Co-interventions will be measured from self-report | At the end of treatment (6 weeks after randomization),1 month after the end of treatment, 3, 6 and 12 months after randomization | 
| Adverse events | Adverse events will be measured from self-report | At the end of treatment (6 weeks after randomization), 1 month after the end of treatment, 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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Photobiomodulation Therapy, LLLT, Motor Control Exercise