Effects of Lumbar Strengthening Training Plus Photobiomodulation on Non-specific Low-back Pain.

Study Overview
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Brief Summary
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The present project aims to investigate the effects of lumbar strengthening training combined with photobiomodulation therapy (PBMT) on functional and psychological aspects in young and older adults with chronic non-specific low back pain. We hypothesized that lumbar strengthening training combined with PBMT should promote greater improvement on functional and psychological variables compared to strengthening training alone (placebo PBMT).

Detailed Description
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The purpose of this study will be to investigate the effects of lumbar strengthening training combined with photobiomodulation therapy (PBMT) therapy by light-emitting diode (LED) on functional and psychological aspects in young and older adults with chronic non-specific low back pain. Initially, all participants will be submitted for a 2-wk familiarization period with physical tests, and then randomized into two groups (N = 16/group): lumbar strengthening training combined with LED PBMT (TR+LED) and lumbar strengthening training combined with placebo PBMT (TR+PLA). Both groups will be submitted to a supervised 8-wk training program (3 x/week) involving a specific lumbar extension exercise on the Roman bench and four complementary exercises to improve core strength and spine stabilization. The groups will receive their respective PBMT (LED or placebo) 30 minutes before each training session, through a device containing 264 LEDs (132 LEDs of 660 nm and 132 LEDs of 850 nm), which will be placed on the lumbar region (between L1 and L5) with the participants lying in the prone position. The placebo LED will be applied with the device turned off. Participans will be blinded to PBM treatments. The following variables will be assessed at pre and post-training: anthropometric, body composition by bioimpedance, level of physical activity by International Physical Activity Questionnaire (IPAQ), maximal voluntary isometric contraction (MVIC) for lumbar extension exercise, short physical performance battery (SPPB), postural balance on a force platform, Schober test for lumbar spine flexion, Tampa Scale of kinesiophobia (TSK), Fear Avoidance Beliefs Questionnaire (FABQ), pain catastrophizing scale (PCS), quality of life by WHOQOL, oswestry disability index (ODI), Roland Morris disability questionnaire (RMDQ), McGILL pain questionnaire, and visual analogue scale (VAS). Shapiro-Wilk and Levene tests will be used to test the normality and homogeneity of the measurements, respectively. Two-way ANOVA (group x time) tests for repeated measures will be performed to assess changes over time and between groups for all dependent variables. Violation of sphericity will adjust using Greenhouse-Geisser correction. The Bonferroni post-hoc test will detect specific differences between groups. When appropriate, the percentage of change (∆%) will be reported according to the following equation: ∆% = [(pre-average post average) / pre-average mean] × 100. Values will be express as mean ± standard deviation. O significance level α will be 0.05.

Official Title
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Effects of Lumbar Strengthening Training Combined With Photobiomodulation Therapy on Functional and Psychological Aspects in Young and Older Adults With Chronic Non-specific Low Back Pain: a Randomized, Placebo-controlled Clinical Trial.

Conditions
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Strengthening Training, Photobiomodulation, Low Back Pain, Quality of Life, Kinesiophobia

Intervention / Treatment
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* Radiation: strengthening training and LED PBMT
* Radiation: strengthening training and placebo PBMT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women aged 18-80 years To be eutrophic (BMI: 25-27 kg/cm2) Self-report of recurrent (≥ 3 x/week) or continuous episodes of nonspecific low back pain for at least 3 months, comprising the lumbar region between L1-L5 To be physiscally active according to the International Physical Activity Questionnaire (IPAQ) Exclusion Criteria: To present a history of musculoskeletal disorders that could affect muscle function To make use of medicines that could affect muscle function. To present low back pain of specific etiology, such as: tumor, herniated disc, facet syndrome, canal stenosis, among others. To have used ergogenic supplements and anabolic steroids for at least six months before study To present severe skin diseases in the lumbar region, such as: erysipelas, eczema, dermatitis, psoriasis and urticaria To have restrictions for exercises practice considering Physical Activity Readiness Questionnaire (PAR-Q) responses.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lumbar strengthening training combined with LED PBMT (TR+LED)<br>Each participant will be submitted to a 8-wk lumbar strengthening training program and will receive the LED PBMT 30 minutes before each training session. | Radiation: strengthening training and LED PBMT<br>* Participants will be submitted to a supervised 8-wk training program (3 d/week) involving a specific lumbar extension exercise on the Roman bench and four complementary exercises to improve core strength and spine stabilization. Participants will receive LED PBMT 30 minutes before each training session, through a device containing 264 LEDs, which will be placed on the lumbar region (between L1 and L5).<br>|
| Placebo Comparator: Lumbar strengthening training combined with placebo PBMT (TR+PLA)<br>Each participant will be submitted to a 8-wk lumbar strengthening training program and will receive the placebo PBMT 30 minutes before each training session. | Radiation: strengthening training and placebo PBMT<br>* Participants will be submitted to a supervised 8-wk training program (3 d/week) involving a specific lumbar extension exercise on the Roman bench and four complementary exercises to improve core strength and spine stabilization. Participants will receive placebo PBMT 30 minutes before each training session, through a off-line device (turned off) containing 264 LEDs, which will be placed on the lumbar region (between L1 and L5).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in postural balance | Postural balance will be assessed on a force platform at pre- and post-training | Baseline and after 8 weeks | 
| Change in low back pain | Low back pain will be assessed with a visual analogue scale (VAS) at pre- and post-training | Baseline and after 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tampa Scale of kinesiophobia (TSK) | The TSK is a 17-item self report checklist using a 4-point Likert scale that was developed as a measure of fear of movement or injury. | Baseline and after 8 weeks | 
| Fear-Avoidance Beliefs Questionnaire (FABQ) | The FABQ is a patient reported questionnaire which specifically focuses on how a patient's fear avoidance beliefs about physical activity and work may affect and contribute to their low back pain and resulting disability. | Baseline and after 8 weeks | 
| Pain Catastrophizing Scale (PCS) | PCS is a instrument used for measuring catastrophic thinking related to pain. | Baseline and after 8 weeks | 
| Oswestry Disability Index (ODI) | ODI is a questionnaire used to assess the subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain. | Baseline and after 8 weeks | 
| Roland Morris Disability Questionnaire (RMDQ) | RMDQ questionnaire is designed to assess self-rated physical disability caused by low back pain | Baseline and after 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Strengthening training, Photobiomodulation, Low back pain, Quality of life, kinesiophobia