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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
148
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.
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.
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
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.
Time frame: 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.
Time frame: At the end of treatment (6 weeks after randomization)
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.
Time frame: 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.
Time frame: 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
Time frame: At the end of treatment (6 weeks after randomization)
Medication intake
The medication intake will be measured from self-report
Time frame: 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
Time frame: 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
Time frame: At the end of treatment (6 weeks after randomization), 1 month after the end of treatment, 3, 6 and 12 months after randomization
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