PBMT Associated With MCE for Chronic Non- Specific Low Back Pain
- Conditions
- Low Back Pain
- Interventions
- Device: Active PBMT + MCEDevice: Placebo PBMT + MCE
- Registration Number
- NCT05487118
- Lead Sponsor
- University of Nove de Julho
- Brief Summary
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
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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 148
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active PBMT + MCE Active PBMT + MCE Active photobiomodulation therapy (PBMT), with a dose of 30 J, will be applied before a protocol of motor control exercises (MCE). Placebo PBMT + MCE Placebo PBMT + MCE Placebo photobiomodulation therapy (PBMT), with a dose of 0 J, will be applied before a protocol of motor control exercises (MCE).
- Primary Outcome Measures
Name Time Method Pain intensity At the end of treatment (6 weeks after randomization) 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.
Disability At the end of treatment (6 weeks after randomization) 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.
- Secondary Outcome Measures
Name Time Method Co-interventions 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 will be measured from self-report
Disability 1 month after the end of the treatment, 3, 6 and 12 months after randomization 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.
Pain intensity 1 month after the end of the treatment, 3, 6 and 12 months after randomization 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.
Medication intake At the end of treatment (6 weeks after randomization), 1 month after the end of treatment, 3, 6 and 12 months after randomization The medication intake will be measured from self-report
Levels of prostaglandin E2 (PGE2) At the end of treatment (6 weeks after randomization) Levels of PGE2 will be measured by blood samples
Adverse events 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 will be measured from self-report
Trial Locations
- Locations (2)
Santa Casa de Misericórdia de Porto Alegre
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Laboratory of Phototherapy and Innovative Technologies in Health
🇧🇷São Paulo, Brazil