Using light therapy to relieve chronic knee pain in obese patients preparing for weight loss surgery

Photobiomodulation in Chronic Knee Pain in Patients Who Are in PreRehabilitation for Bariatric Surgery: Double Blind, Randomized, Controlled Placebo Clinical Trial

This study is testing whether light therapy can help reduce knee pain and improve movement in obese patients getting ready for weight loss surgery.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 62 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: University of Nove de Julho (Academic / other)
• Drugs / interventions: prednisone
• Locations: 1 site (Goiânia, Goiás)
• Trial ID: NCT05816798 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of photobiomodulation (PBM) therapy in reducing chronic knee pain and improving functionality in obese patients who are preparing for bariatric surgery. It is a double-blind, randomized, placebo-controlled trial that will assess pain intensity and knee function through various validated measures. The study aims to determine if PBM can serve as an effective analgesic treatment and modify pain pathways in this specific patient population. Participants will receive either active PBM treatment, standard physiotherapy, or a placebo treatment.

Who should consider this trial

Good fit: Ideal candidates are obese patients with chronic knee pain lasting more than three months who are scheduled for bariatric surgery.

Not a fit: Patients who do not have chronic knee pain or those who are not eligible for bariatric surgery will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce chronic knee pain and improve the quality of life for obese patients preparing for bariatric surgery.

How similar studies have performed: Other studies have shown promising results with photobiomodulation for pain relief, suggesting potential success for this approach in similar patient populations.

Eligibility criteria

Inclusion Criteria:

* Obese patients with indication for bariatric surgery performed in routine follow-up at the Gastric Surgery Outpatient Clinic of HC-UFG;
* Patients with chronic pain (\> 3 months) in the knees bilaterally. Patients will be asked in the initial evaluation if they feel pain located in the topography of the knees that has been compromising their functionality both in daily activities and at work, and that lasts for more than or equal to 3 months. This pain may be reported as continuous or intermittent;
* Sign the Informed Consent Term approved by the HC-UFG Ethics Committee.

Exclusion Criteria:

* \- Loss of follow-up in the outpatient clinic of origin and in the Physiotherapy sector, even though the use of laser therapy was maintained according to the study protocol;
* Any reported adverse effects from the use of FBM reported;
* Patients in whom there are changes in the medications being used for chronic pain during the study protocol will be excluded from this study. Minimal changes in the dosages of medications already in use can be tolerated, as long as there are no changes in the type of medication, but only in the prescribed dose. These modifications throughout the study, if they occur, will be described.
* Death
* Withdrawal of the informed consent by the participant
* If the patient, for any reason, is excluded from the indication of bariatric surgery
* Emergence during the study of any of the non-inclusion criteria, like: .
* Patients with other rheumatologic diseases and/or systemic inflammatory diseases (rheumatoid arthritis, Reiter's arthritis, ankylosing spondylitis, generalized polyarthritis) or previous musculoskeletal diseases in the knees;
* Clinical manifestations or complaints of knee arthralgia related to diseases other than obesity.
* Previous use in the last 90 days of treatment with the use of Phototherapy for the same or another indication;
* Clinical signs of neuropathy, including radiculopathies and peripheral nerve injuries;
* Pain in the lower limb, originating from the lumbar spine (lombosciatalgia)
* Use of corticosteroids at an immunosuppressive dose (20mg daily of prednisone or equivalent for at least 14 days);
* Infection or tumor at the site of therapy application;
* Current chronic infections such as tuberculosis or chronic hepatitis treated or not.
* Blood clotting disorders (including thrombosis) at the application site.
* Diagnosis of fibromyalgia;
* Serious psychiatric disorders that require psychiatric care;
* Systemic injections and/or joint injections of corticosteroids or hyaluronic acid during the last 48 hours prior to the initial assessment of the study;
* Psychoaffective disorder that compromises adherence to treatment;
* Any history of sensitivity to light or phototherapies.

Where this trial is running

Goiânia, Goiás

• Gastric Outpatient Clinic of HC-UFG — Goiânia, Goiás, Brazil (Recruiting)

Study contacts

• Principal investigator: Rebeca B Cecatto, MD PHD — Nove de Julho University
• Study coordinator: Rebeca B Cecatto, MD PHD

Conditions Chronic Knee Pain; Obesity, Morbid; Photobiomodulation; Chronic knee pain; Obesity Morbid; Central and periferic sensitivity; Nociception