Knee pain is among the most common reasons for musculoskeletal pain consultations, accounting for nearly 4 million primary care visits annually. Knee pain can have different causes such as, tendinopathies, synovitis, bursitis, trauma, etc. Considering the importance and high incidence of musculoskeletal disorders that affect the knee joint, a variety of therapeutic modalities has been employed to alleviate pain and repair the tissue. Among these conservative treatments, photobiomodulation therapy (PBMT) has been shown to stimulate tendon and ligament healing, and decrease the pain. Therefore, the aim of this study is to determine the effectiveness of the Multi Radiance Medical® Super Pulsed Laser, manufactured by Multi Radiance Medical®, for adjunctive use in providing temporary relief of chronic knee pain of musculoskeletal origin.
To achieve the proposed objectives it will be performed a randomized, triple-blind (patients, therapists, outcome assessors), placebo-controlled trial, with voluntary patients with chronic knee pain. Eighty-six patients will be randomly allocated to two treatment groups: 1. Active Multi Radiance Medical® Super Pulsed Laser or Placebo Multi Radiance Medical® Super Pulsed Laser. The patients will be treated by a blinded therapist. Treatment administration will be performed 3 times a week, for four consecutive weeks, yielding 12 treatments (each treatment administration one to two days apart). The outcomes will be obtained at the stabilization phase, baseline (pre-procedure), end of treatment and one week after the conclusion of treatment. The data will be collected by a blinded assessor. The statistical analysis will follow the intention-to-treat principles. The project was also approved by the Research Ethics Committee from Universidade Nove de Julho, under the number 5.332.202. 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. The investigators will analyze: degree of pain, levels of prostaglandin E2, subjective knee evaluation, patient satisfaction, blinded efficacy and adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
86
Placebo, without therapeutic dose.
Active with a dose of 8.02 J per site.
Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
RECRUITINGLaboratory of Phototherapy and Innovative Technologies in Health
São Paulo, Brazil
RECRUITINGDegree of pain rating
Degree of pain rating will be measured by 0-100 standardized Visual Analog Scale (VAS). Higher scores mean worse outcome.
Time frame: 4 weeks (end of treatment).
Degree of pain rating
Degree of pain rating will be measured by 0-100 standardized Visual Analog Scale (VAS). Higher scores mean worse outcome.
Time frame: One-week after the conclusion of the treatment.
Levels of Prostaglandin E2 (PGE2)
Levels of PGE2 will be measured by blood samples.
Time frame: 4 weeks (end of treatment) and one-week after the conclusion of the treatment.
Subjective knee evaluation
Subjective knee evaluation will be measured by the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form consisting in 18 items and contains the following three domains: 1) symptoms, including pain, stiffness, swelling, locking/catching, and giving way; 2) sports and daily activities; and 3) current knee function and knee function prior to knee injury (not included in the total score). Scores range from 0 points (lowest level of function and highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Time frame: 4 weeks (end of treatment) and one-week after the conclusion of the treatment.
Patient satisfaction
Patient satisfaction will be measured by 1-item Likert Scale. The scale uses the following responses: very satisfied = 5; somewhat satisfied = 4; neither satisfied nor dissatisfied = 3; somewhat dissatisfied n=2; very dissatisfied =1. Highest scores indicates better satisfaction.
Time frame: 4 weeks (end of treatment) and one-week after the conclusion of the treatment.
Blinding efficacy
The blinding efficacy will be measured by the percentage of volunteers and outcome assessor who correctly perceived their procedure group assignment and the percentage of volunteers and outcome assessor who did not correctly perceive their procedure group .
Time frame: 4 weeks (end of treatment) and one-week after the conclusion of the treatment.
Adverse events
Adverse events will be measured by report.
Time frame: 4 weeks (end of treatment) and one-week after the conclusion of the treatment.
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