The goal of this clinical trial is to evaluate the effectiveness of PBMT for adjunctive use in providing temporary relief of minor chronic low back pain of musculoskeletal origin. The main questions it aims to answer are: (i) Is PBMT able to decrease pain intensity in patients with chronic low back pain of musculoskeletal origin? (ii) Is PBMT able to decrease disability in patients with chronic low back pain of musculoskeletal origin? Researchers will compare active PBMT with placebo PBMT to see if active PBMT provides temporary relief of minor chronic low back pain of musculoskeletal origin.
To achieve the proposed objective it will be performed a randomized, triple-blinded (patients, therapists, and outcome assessors), placebo-controlled randomized study. Sixty-eight patients will be randomly allocated to two treatment groups: 1. Active treatment: Thirty-four patients will receive treatment with active PBMT. 2. Placebo treatment: Thirty-four patients will receive treatment with placebo PBMT. The treatment administration protocol will comprise: six sessions of treatment (with active or placebo PBMT, according to the previous randomization), two sessions a week, for three consecutive weeks, each procedure administration three to four days apart. The data will be collected by a blinded assessor. The study will comprise the following stages/phases: 1. Pre procedure phase activities: (a) signing of informed consent form; (b) assignment of subject identification number; (c) randomization of subject to procedure group; (d) initial study qualification evaluation. 2. Rescue pain management stabilization phase: (a) determination and recording of the individualized rescue pain management regimen; (b) VAS recording; (c) continued study eligibility evaluation. 3. Pre-procedure administration phase activities: (a) pre-procedure variables recorded; (b) recording of pre-procedure measures. 4. Procedure administration phase activities: (a) establishment of procedure administration visit schedule; (b) study procedure administration; (c) study procedure administration protocol; (d) procedure administration phase visits and evaluations. 5. Post-procedure administration phase: one-month (30±4 days) period immediately following completion of the procedure administration phase. The statistical analysis will follow the intention-to-treat principles as primary analysis, and per-protocol analysis will be secondary supportive analysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
68
Active with a dose of 165 J per site, resulting in a total dose of 495J.
Placebo, without therapeutic dose.
Laboratory of Phototherapy and Innovative Technologies in Health
São Paulo, Brazil
RECRUITINGProportion of individual subject successes
Measured through degree of pain rating measured by an 0-100 mm (0-10 cm) Visual Analog Scale (VAS), that evaluates the degree of pain perceived by the patient on a scale ranging from 0 to 100, with 0 being 'no pain' and 10 'the worst pain imaginable'. Higher scores mean worse outcome.
Time frame: 15 minutes after the final treatment (6th).
Degree of pain
Degree of pain will be measured by an 0-100 mm (0-10 cm) Visual Analog Scale (VAS), that evaluates the degree of pain perceived by the patient on a scale ranging from 0 to 100, with 0 being 'no pain' and 10 'the worst pain imaginable'. Higher scores mean worse outcome.
Time frame: 15 minutes after the final treatment (6th) and one month after the final treatment.
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: 15 minutes after the final treatment (6th) and one month after the final treatment.
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