BETY with intra-articular injections for knee osteoarthritis
An Investigation of the Effectiveness of the BETY Exercise Program, Based on the Biopsychosocial Model, in Individuals With Knee Osteoarthritis Who Have Received Intra-articular Injections
This will try whether adding BETY to intra-articular knee injections reduces pain and improves function in adults with stage 2 or 3 knee osteoarthritis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hacettepe University Academic / other |
| Locations | 1 site (Ankara, Samanpazarı) |
| Trial ID | NCT07496203 on ClinicalTrials.gov |
What this trial studies
This interventional study enrolls adults with Kellgren-Lawrence stage 2 or 3 knee osteoarthritis who recently received an intra-articular injection and randomizes them to receive BETY alongside their injection regimen. Participants will be followed at the Hacettepe University site for clinical outcomes such as pain, physical function, and health-related quality of life. Key exclusions include stage 4 radiographic disease, recent knee surgery or physiotherapy, major psychiatric illness, malignancy, chronic infectious or rheumatologic conditions, and peripheral vascular or neuropathic disease. The goal is to compare patient-centered benefit and safety of adding BETY to standard intra-articular approaches.
Who should consider this trial
Good fit: Adults aged 18 or older with symptomatic knee osteoarthritis classified as Kellgren-Lawrence stage 2 or 3 who have had an intra-articular knee injection within the past month and can read and sign informed consent are ideal candidates.
Not a fit: Patients with advanced (stage 4) knee osteoarthritis, recent major knee surgery or physiotherapy, major psychiatric illness, malignancy, chronic infectious or rheumatologic disease, peripheral vascular disease, or neuropathy are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, adding BETY could reduce knee pain and improve function and quality of life for people with moderate knee osteoarthritis.
How similar studies have performed: Other intra-articular therapies (like PRP, hyaluronic acid, and corticosteroids) have shown mixed but sometimes favorable effects for knee OA, while the specific use of BETY as an add-on is novel and not well established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of knee osteoarthritis according to ACR knee osteoarthritis diagnostic criteria * Being in stage 2 or 3 according to Kellgren-Lawrence radiological staging criteria * having received an intra-articular injection in the knee within the past month * To be 18 years of age or older * Being a reader-writer * Having read and signed the informed consent Exclusion Criteria: * History of major psychiatric illness * Having malignant disease * Having chronic infectious or other rheumatologic diseases * Serious knee trauma or surgical operation in the last 6 months * Having collagen tissue disease * History of peripheral vascular disease or neuropathy * Being in stage 4 according to Kellgren Lawrence radiologic staging criteria * To have received a physiotherapy program for the relevant knee in the last 3 months
Where this trial is running
Ankara, Samanpazarı
- Hacettepe University — Ankara, Samanpazarı, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Aysima Barlak, PT, MSc
- Email: fztaysimabarlak@gmail.com
- Phone: +903123052525
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.