Status:
UNKNOWN
Photobiomodulation Therapy to Reduce Pain and Inflammation in Patients With Gonarthrosis
Lead Sponsor:
D'Or Institute for Research and Education
Collaborating Sponsors:
TERGOS PESQUISA E ENSINO S.A
Conditions:
Osteoarthritis
Gonarthrosis
Eligibility:
All Genders
50-75 years
Phase:
NA
Brief Summary
Osteoarthritis (OA) is one of the main causes of chronic pain and physical disability, which directly impacts the quality of life of patients. The prevalence of OA among adults over 60 years of age is...
Detailed Description
Osteoarthritis (OA) is one of the main causes of chronic pain and physical disability, which directly impacts the quality of life of patients. The prevalence of OA among adults over 60 years of age is...
Eligibility Criteria
Inclusion
- Patients of both sexes, aged between 50 and 75 years;
- Uni or bilateral symptomatic gonarthrosis grades II or III according to the Kellgren-Lawrence classification confirmed on radiographs with weight bearing in anteroposterior, lateral and axial patella. When the disease is bilateral, the knee indicated by the patient as being the most symptomatic will be included;
- Complaint of knee pain ≥4 on the Visual Analogue Scale at the time of inclusion in the study;
- Able to walk independently, with or without walking aids;
- Cognitive ability to answer questionnaires and perform physical tests;
- Agreement to participate in the study by signing the Free and Informed Consent Form (TCLE).
Exclusion
- Diagnosis of active malignancy except basal cell carcinoma (BCC);
- Diseases or neurological conditions that compromise the ability to perform the physical tests;
- Epilepsy;
- Skin lesions on the lower limb, close to the TFBM application site;
- Tattoos on the lower limb, close to the TFBM application site;
- Unicompartmental or total knee arthroplasty in the knee included in the study;
- History of direct trauma to the knee included in the study within the last six months;
- Active systemic inflammatory disease;
- Rheumatological diseases;
- Any previous procedure with an intra-articular approach to the knee in the last six months;
- Anticipation of adopting another form of treatment during the study period, including arthroplasty;
- Patients undergoing knee shock wave treatment in the knee included in the study;
- Absence, inability or refusal to sign the informed consent form.
Key Trial Info
Start Date :
August 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2025
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT05975957
Start Date
August 15 2023
End Date
August 31 2025
Last Update
August 22 2023
Active Locations (1)
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1
Hospital Glória D'Or
Rio de Janeiro, Brazil, 22211-230