Using Super Pulsed Laser to Treat 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

This study is testing if a special laser treatment can help people with chronic knee pain feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 86 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: University of Nove de Julho (Academic / other)
• Locations: 2 sites (Porto Alegre, Rio Grande Do Sul and 1 other locations)
• Trial ID: NCT05830344 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of the Multi Radiance Medical® Super Pulsed Laser in providing temporary relief for chronic knee pain of musculoskeletal origin. It involves a randomized, triple-blind, placebo-controlled design with 86 participants who will receive either the active laser treatment or a placebo. Treatments will be administered three times a week over four weeks, with outcomes assessed at baseline, end of treatment, and one week post-treatment. The study aims to evaluate pain levels, patient satisfaction, and any adverse events associated with the treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 50 with unilateral chronic knee pain of benign musculoskeletal origin.

Not a fit: Patients with knee pain due to serious underlying conditions or those not fluent in Portuguese may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a non-invasive option for patients suffering from chronic knee pain.

How similar studies have performed: Previous studies on photobiomodulation therapy have shown promising results, suggesting potential effectiveness for similar conditions.

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 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.

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 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.
* Local corticosteroids and/or botulinum toxin (Botox®) injection for knee pain relief within 30 days prior to study enrollment.
* Treatments such as chiropractic care, and acupuncture within 30 days prior to study enrollment.
* Current, active chronic pain disease, such as chronic fatigue syndrome, fibromyalgia, endometriosis, inflammatory bowel disease, interstitial cystitis diabetic neuropathic pain,
* Current cancer or treatment for cancer in the past 6 months.
* Significant heart conditions including chronic heart failure (CHF) and implantable heart devices such as a pacemaker.
* Active infection, wound, or other external trauma to the areas to be treated with the PBMT.
* Medical, physical, or other contraindications for, or sensitivity to, light therapy.
* Pregnant, breast feeding, or planning pregnancy prior to the end of study participation.
* Female subject of childbearing age who is unwilling to engage in effective medical contraceptive use while sexually active during the study procedure administration phase.
* Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in past two years.
* Developmental disability or cognitive impairment that in the opinion of the principal investigator would preclude adequate comprehension of the informed consent form and/or ability to record the necessary study measurements.
* Any other medical condition or medication use that in the opinion of the principal investigator may affect the study treatment and or outcomes assessment.

Where this trial is running

Porto Alegre, Rio Grande Do Sul and 1 other locations

• Santa Casa de Misericórdia de Porto Alegre — Porto Alegre, Rio Grande Do Sul, Brazil (Recruiting)
• Laboratory of Phototherapy and Innovative Technologies in Health — São Paulo, Brazil (Recruiting)

Study contacts

• Study coordinator: Ernesto Leal Junior, PhD

Conditions Knee Pain Chronic; Photobiomodulation Therapy; LLLT