Comparison of Effect on Serum Inflammatory Markers Following Viscosupplementation Versus Conventional Management in Knee Osteoarthritis
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 118
- Locations
- 1
Study Overview
Brief Summary
Osteoarthritis of the knee is a common degenerative joint disorder associated with cartilage degradation and low grade inflammation leading to pain and functional limitation. Intra articular hyaluronic acid injection, also known as viscosupplementation, is used to improve joint lubrication and has shown potential anti inflammatory effects. This randomized comparative trial aims to compare the effect of viscosupplementation versus conventional management on serum inflammatory markers interleukin 6 and tumor necrosis factor alpha as well as functional outcomes in patients with primary knee osteoarthritis. A total of 118 participants fulfilling American College of Rheumatology clinical and radiographic criteria for grade II or III knee osteoarthritis will be randomly assigned into two groups. The study group will receive a single intra articular injection of high molecular weight hyaluronic acid along with exercise therapy, while the control group will receive exercise therapy and physical modalities only. Serum interleukin 6, tumor necrosis factor alpha, Knee Injury and Osteoarthritis Outcome Score, and physical performance tests will be assessed at baseline and after four weeks of intervention to evaluate changes in inflammatory markers and physical function.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 30.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Adults of either gender with primary tibiofemoral knee osteoarthritis fulfilling ACR clinical and radiographic criteria, radiographic Kellgren Lawrence grade II or III, and body mass index less than 40, who are willing to provide written informed consent.
Exclusion Criteria
- •History of bleeding disorders; any acute injury or recent surgery within the past three months; use of anti-inflammatory drugs for more than seven days in the past four weeks or within five days before starting the trial; current use of corticosteroids or immunosuppressive drugs; presence of any acute co-existing illness; prior hyaluronic acid injection or unwillingness to receive hyaluronic acid; any overlying skin infection; venous or lymphatic stasis.
Investigators
Dr Ishita
VMMC and Safdarjung hospital