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

NCT05830344 | Unknown FDA Device

• 1 other identifier: 5.767.644
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 2

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.

Conditions

Knee Pain Chronic

Keywords

Photobiomodulation Therapy; LLLT

Outcome Measures

Primary Outcomes (1)

• Degree of pain rating

  Degree of pain rating will be measured by 0-100 standardized Visual Analog Scale (VAS). Higher scores mean worse outcome.

  4 weeks (end of treatment).

Secondary Outcomes (6)

• Degree of pain rating

  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.

• Patient satisfaction

  4 weeks (end of treatment) and one-week after the conclusion of the treatment.

• Blinding efficacy

  4 weeks (end of treatment) and one-week after the conclusion of the treatment.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo treatment will be irradiated using a Multi Radiance Medical Super Pulsed Laser, manufactured by Multi Radiance Medical® (Solon,Ohio, USA), at 5 sites in the knee area, without any emission of therapeutic dose. The treatment will be performed 3 times a week, for four consecutive weeks, yielding 12 treatments. The sounds and signals emitted from the device as well as the information displayed on the screen will be identical, regardless of the type of treatment (active or placebo).

Device: Placebo Multi Radiance Medical® Super Pulsed Laser

Active

EXPERIMENTAL

Active treatment will be irradiated using a Multi Radiance Medical Super Pulsed Laser, manufactured by Multi Radiance Medical® (Solon,Ohio, USA), at 5 sites in the knee area, with a dose of 8.02 J per site. The treatment will be performed 3 times a week, for four consecutive weeks, yielding 12 treatments.

Device: Active Multi Radiance Medical® Super Pulsed Laser

Interventions

Placebo Multi Radiance Medical® Super Pulsed Laser DEVICE

Placebo, without therapeutic dose.

Placebo

Active Multi Radiance Medical® Super Pulsed Laser DEVICE

Active with a dose of 8.02 J per site.

Active

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 20.
• 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.
• Previous Records Review, such as x-ray, MRI, CT scans, etc., where available, that indicate muscle or ligament injury and the absence of Degenerative Joint Disorder (DJD).
• Medical history consistent with one of the etiologies of knee pain falling within the scope of this study.
• Physical examination of the knee that yields one or both of the following findings: Increased pain upon range of motion and/or increased pain and weakness upon knee extension, knee flexion, or gait.
• Subject is willing and able to maintain his or her individualized pain regimen as determined by the study principal investigator at baseline as needed to manage any knee pain that may arise throughout the course of study duration, whilst refraining from consuming other over the counter and/or prescription medication(s) and/or herbal supplements intended for the relief of pain and/or inflammation, and/or partaking in other treatments/therapies.

You may not qualify if:

• 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 50.
• 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.
• Peripheral nerve disease.
• Rheumatoid arthritis.
• Hip or ankle disease.
• Congenital or acquired bony deformity in the ipsilateral lower extremity.
• Secondary orthopedic problems that in the opinion of the principal investigator may affect the study treatment and or outcomes assessment.

Sponsors & Collaborators

• University of Nove de Julho: lead
• Multi Radiance Medical: collaborator

Study Sites (2)

Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-074, Brazil

RECRUITING

Laboratory of Phototherapy and Innovative Technologies in Health

São Paulo, 01504-001, Brazil

RECRUITING

Central Study Contacts

Ernesto Leal Junior, PhD

CONTACT

+551133859134; ernesto.leal.junior@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A researcher will program the device (placebo or active) and will be instructed not to inform the patients or other researchers as to the type of treatment (placebo or active). Therefore, the researcher responsible for the treatment, the investigator and the outcome assessor will be blinded to the type of treatment being administered to the patients. The sounds and signals emitted from the device as well as the information displayed on the screen will be identical, regardless of the type of treatment (placebo or active).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: April 26, 2023
• Study Start: April 27, 2023
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will become available during five years after the study completion.
• Access Criteria: All IPD that underlie results in a publication will be available on reasonable request.

Locations

BR (2)