NCT05830344

Effects of Multi Radiance Medical® Super Pulsed Laser on Chronic Knee Pain

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: University of Nove de Julho · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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: [phone] - Email: [e-mail] 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.

Conditions

• Knee Pain Chronic

Interventions

Type	Name	Description
DEVICE	Placebo Multi Radiance Medical® Super Pulsed Laser	Placebo, without therapeutic dose.
DEVICE	Active Multi Radiance Medical® Super Pulsed Laser	Active with a dose of 8.02 J per site.

Timeline

• Start date: 2023-04-27
• Primary completion: 2023-10-01
• Completion: 2023-12-01
• First posted: 2023-04-26
• Last updated: 2023-08-14

Locations

2 sites across 1 country: Brazil

Regulatory

• FDA-regulated device study