Evaluation of the Effect of Multi Radiance Medical® Super Pulsed Laser for Adjunctive Use in Providing Temporary Relief of Chronic Knee Pain of Musculoskeletal Origin
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Knee Pain Chronic
- Sponsor
- University of Nove de Julho
- Enrollment
- 86
- Locations
- 2
- Primary Endpoint
- Degree of pain rating
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Ernesto Cesar Pinto Leal Junior
Full professor
University of Nove de Julho
Eligibility Criteria
Inclusion Criteria
- •Signed consent form.
- •Aged between 18 and 50 years, inclusive.
- •Any gender.
- •Subject is fluent in Portuguese.
- •The volunteers' presenting primary (dominant) pain is in the region of the right or left knee only. i.e., it is unilateral.
- •Self-reported degree of pain rating on the 0-100 VAS pain scale for the target knee is 50 or greater.
- •Self-reported degree of pain rating on the 0-100 VAS pain scale for the non-target knee is less than
- •Knee pain is episodic chronic, defined as having occurred and recurred over regular or irregular periods or intervals of time, persisting over at least the last 3 months.
- •Volunteers' knee pain is of benign musculoskeletal origin wherein the etiology is tendinopathies, synovitis, bursitis, strain, and sprain, of traumatic or non-traumatic origin, as determined by the principal investigator based on any one or combination of the following:
- •Prior diagnosis by a qualified licensed medical professional current within the last 2 years evidenced through source documentation.
Exclusion Criteria
- •A volunteer who satisfies any one or more of the following criteria will be excluded from study participation:
- •The volunteers' presenting primary pain is located outside or in addition to the knee.
- •The volunteers' presenting primary pain is bilateral, i.e., equally dominant in the right and left knees.
- •Self-reported degree of pain rating on the 0-100 VAS pain scale for the target knee is less than
- •Self-reported degree of pain rating on the 0-100 VAS pain scale for the non-target knee is 20 or greater.
- •Knee pain is acute, defined as having persisted less than half the time over less than the last 3 months.
- •Knee pain is not episodic, such that it has either been continually present without respite over the past 3 months and/or there has not been recurrent episodes within the past 3 months.
- •Volunteers' knee pain is of other than, or in addition to, benign musculoskeletal origin wherein the etiology is tendinopathies, synovitis, bursitis, strains, and sprains from traumatic or non-traumatic origin, and/or the etiology of the subject's knee pain cannot be satisfactorily ruled out.
- •Prior surgical intervention to the target knee that in the opinion of the principal investigator may affect the study treatment and or outcomes assessment.
- •Neurologic deficits that in the opinion of the principal investigator may affect the study treatment and or outcomes assessment.
Outcomes
Primary Outcomes
Degree of pain rating
Time Frame: 4 weeks (end of treatment).
Degree of pain rating will be measured by 0-100 standardized Visual Analog Scale (VAS). Higher scores mean worse outcome.
Secondary Outcomes
- Patient satisfaction(4 weeks (end of treatment) and one-week after the conclusion of the treatment.)
- Adverse events(4 weeks (end of treatment) and one-week after the conclusion of the treatment.)
- Levels of Prostaglandin E2 (PGE2)(4 weeks (end of treatment) and one-week after the conclusion of the treatment.)
- Subjective knee evaluation(4 weeks (end of treatment) and one-week after the conclusion of the treatment.)
- Degree of pain rating(One-week after the conclusion of the treatment.)
- Blinding efficacy(4 weeks (end of treatment) and one-week after the conclusion of the treatment.)