Effects of Laser Therapy and Exercise in Participants With Chronic Low Back Pain
- Conditions
- Low Back Pain (LBP)
- Interventions
- Device: exercise + photobiomodulation therapy
- Registration Number
- NCT04287725
- Lead Sponsor
- Federal University of the Valleys of Jequitinhonha and Mucuri
- Brief Summary
The objective of this clinical trial is to evaluate the additional effects of Laser Therapy in participants with chronic non-specific low back pain in the short and long term.
- Detailed Description
The objective of this clinical trial is to evaluate the additional effects of Photobiomodulation Therapy in participants with chronic non-specifc low back pain in the short and long term.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 130
- Patients with non-specific chronic LBP, defined as pain or discomfort between the costal margins and inferior gluteal folds with or without referred pain to the lower limbs;
- Persistent LBP for at least 3 months;
- Low back pain of intensity reported 3 or higher by the Visual Analogue Scale (VAS), at least once in the previous 7 days;
- Aged between 18 and 65 years;
- Both genders.
- Patients with severe skin diseases (eg, skin cancer, erysipelas, severe eczema, severe dermatitis, severe psoriasis and severe hives lupus);
- Participants with known or suspected serious spinal pathology (e.g., fractures, tumors, inflammatory, rheumatologic disorders, or infective diseases of the spine);
- Nerve root compromise;
- History of previous spinal surgery (even in a segment other than the lumbar spine) or scheduled surgery;
- Pain due to or associated with pregnancy or structural deformity (for example, scoliosis);
- Pregnancy;
- Comorbid health conditions that could prevent active participation in the exercise programs such as high blood pressure, pregnancy, or cardio-respiratory illnesses;
- Having answered "yes" to any of the questions in the Physical Activity Readiness Questionnaire (PAR-Q);
- Be treated with PBMT;
- Being under physiotherapeutic treatment or perform physical exercise;
- Who are using NSAID or start it during the trial;
- Who have inability to tolerate the proposed experimental procedures (such as tests of mobility and strength of the lumbar muscles).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description exercise + placebo Photobiomodulation therapy (PBMT) exercise + photobiomodulation therapy Exercise protocol: The program will consist of individual sessions of progressive and submaximal exercises with aerobic training on a treadmill and spine strengthening exercise. Photobiomodulation therapy: will be performed using the placebo super pulsed laser (904nm). exercise + active Photobiomodulation therapy (PBMT) exercise + photobiomodulation therapy Exercise protocol: The program will consist of individual sessions of progressive and submaximal exercises with aerobic training on a treadmill and spine strengthening exercise. Photobiomodulation therapy: will be performed using the active super pulsed laser (904nm).
- Primary Outcome Measures
Name Time Method Change Of Pain intensity at 3 months post-intervention Baseline; 3 months after the last intervention Measured by the Visual Analogue Scale (VAS). The VAS 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'.
Change Of Pain intensity at post-intervention Baseline; Immediately after the last intervention Measured by the Visual Analogue Scale (VAS). The VAS 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'.
Change of Disability associated with low back pain at post-intervention Baseline; Immediately after the last intervention Measured by the Roland-Morris Disability Questionnaire. The questionnaire consists of 24 items that describe situations that patients may have difficulty performing on a daily basis due to LBP. The greater the number of affirmative answers is, the higher the level of functional disability associated with LBP.
Change of Disability associated with low back pain at 3 months post-intervention Baseline; 3 months after the last intervention Measured by the Roland-Morris Disability Questionnaire. The questionnaire consists of 24 items that describe situations that patients may have difficulty performing on a daily basis due to LBP. The greater the number of affirmative answers is, the higher the level of functional disability associated with LBP.
- Secondary Outcome Measures
Name Time Method Change Of Pain intensity at 12 months post-intervention Baseline; 12 months after the last intervention Measured by the Visual Analogue Scale (VAS). The VAS 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'.
Change of Disability associated with low back pain at 12 months post-intervention Baseline; 12 months after the last intervention Measured by the Roland-Morris Disability Questionnaire. The questionnaire consists of 24 items that describe situations that patients may have difficulty performing on a daily basis due to LBP. The greater the number of affirmative answers is, the higher the level of functional disability associated with LBP.
Changes os Mental health Baseline; Immediately after the last intervention; 3 and 12 months after the last intervention Measured by the reduced version of the Anxiety, Depression and Stress Scale-21. It is a self-report instrument composed of three subscales with seven items each, to assess depression, anxiety and stress in the previous week. The variations in scores correspond to symptom levels, which vary between "normal" and "very severe".
Changes of Strength of the trunk extensor muscle Baseline; Immediately after the last intervention; 3 and 12 months after the last intervention Measured by the Sorensen Test
Changes of Disability associated with low back pain Baseline; Immediately after the last intervention; 3 and 12 months after the last intervention Measured by the Oswestry Low Back Pain Disability Questionnaire. The scale consists of 10 questions with six alternatives, the value of which ranges from 0 to 5. It is classified into: minimum disability (0 - 20%), moderate disability (21- 40%), severe disability (41 - 60%) , a patient who is disabled (61 - 80%), and an individual restricted to bed (81 - 100%).
Changes of Mobility of the lumbar and sacral segments Baseline; Immediately after the last intervention; 3 and 12 months after the last intervention Measured by the modified Schober test