NCT05816798RecruitingPhase 2/3
Photobiomodulation in Chronic Knee Pain in Patients Who Are in PreRehabilitation for Bariatric Surgery
Photobiomodulation in Chronic Knee Pain in Patients Who Are in PreRehabilitation for Bariatric Surgery: Double Blind, Randomized, Controlled Placebo Clinical Trial
Source: ClinicalTrials.gov · Last updated 6 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Chronic pain is a global public health problem, which intensifies even more in the obese population, reaching about 33% of these patients. Among the topography, chronic knee pain affects 80%, constituting an important cause of disability and decreased quality of life. In addition, in grade 3 obesity, also called morbid obesity, in which bariatric surgery is already indicated, knee pain makes it difficult or prevents participation in the pre-habilitation program that includes physical therapy through therapeutic exercises with the aim of reducing postoperative complications. In this sense, a double-blind, randomized, placebo-controlled clinical trial will be conducted with the objective of evaluating the effect of photobiomodulation (PBM) on pain and functionality of obese patients with chronic knee pain who are in a prehabilitation program for bariatric surgery, discussing its role as an analgesic therapy and modifier of peripheral and central sensitization mechanisms of the pain pathway. PBM is a safe treatment option, with no undesirable effects and low cost. The primary outcomes will be pain intensity, through visual analogue scale, and Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire, validated version for Portuguese - Brazil. Secondary outcomes will be pressure pain threshold and rolling pinch maneuver measured by digital algometer. Other exploratory outcomes will be 6-minute walk test, knee range of motion, SF-36 quality of life questionnaire. There will be 2 groups: an intervention group (photobiomodulation associated with standard physiotherapy treatment) and another placebo group (device turned off associated with the same standard physiotherapy treatment). The application sites will be knees and lumbar paravertebral 2 times a week for 12 weeks. The dosimetric standards will be 4J/point in the knees and 3J/point in the lumbar. The results obtained will be statistically analyzed and later published in a scientific journal.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 62 (estimated)
- First submitted
- 22 Mar 2023
- Start date
- 28 Jul 2023
- Primary completion date
- 1 May 2025
- Lead sponsor
- University of Nove de Julho
- Diseases
- Obesity
- NCT number
- NCT05816798
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 62
- From 28 Jul 2023 to the primary completion date, 1 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- \- 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;
- 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.
- If the patient, for any reason, is excluded from the indication of bariatric surgery
- 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;
- Previous use in the last 90 days of treatment with the use of Phototherapy for the same or another indication;
- Use of corticosteroids at an immunosuppressive dose (20mg daily of prednisone or equivalent for at least 14 days);
- Systemic injections and/or joint injections of corticosteroids or hyaluronic acid during the last 48 hours prior to the initial assessment of the study;
Other illness
- Clinical manifestations or complaints of knee arthralgia related to diseases other than obesity.
- 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.
- Serious psychiatric disorders that require psychiatric care;
- Psychoaffective disorder that compromises adherence to treatment;
- Any history of sensitivity to light or phototherapies.
Other
- Any reported adverse effects from the use of FBM reported;
- Death
- Withdrawal of the informed consent by the participant
- Emergence during the study of any of the non-inclusion criteria, like: .
- Clinical signs of neuropathy, including radiculopathies and peripheral nerve injuries;
- Pain in the lower limb, originating from the lumbar spine (lombosciatalgia)
- Diagnosis of fibromyalgia;
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gastric Outpatient Clinic of HC-UFG Coordinator of this site? Confirm its status | Goiânia | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.