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New treatment option for Chronic Knee Pain
Official title Photobiomodulation in Chronic Knee Pain in Patients Who Are in PreRehabilitation for Bariatric Surgery
ClinicalTrials.gov ID: NCT05816798
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- Sign the Informed Consent Term approved by the HC-UFG Ethics Committee.
You likely can't join if
- \- Loss of follow-up in the outpatient clinic of origin and in the Physiotherapy sector, even though the use of laser therapy was maintained...
- 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...
- Death
- Withdrawal of the informed consent by the participant
- If the patient, for any reason, is excluded from the indication of bariatric surgery
See the full eligibility 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...
- Sign the Informed Consent Term approved by the HC-UFG Ethics Committee.
- \- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Goiânia, Goiás, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Goiânia, Goiás, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.