Effectiveness of Intra- Articular Platelet Rich Plasma with Hyaluronic Acid in comparison with Intra- Articular Botulinum Toxin Type-A with Hyaluronic Acid in improving pain and functional limitation in Osteoarthritis of Knee: A Randomized Clinical Trial.
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- 1.To evaluate the efficacy of intra- articular Platelet rich plasma with Hyaluronic Acid (PRP with HA) in comparison with intra- articular Botulinum Toxin A with Hyaluronic Acid on knee pain.
Study Overview
Brief Summary
Intra-articular injections like PRP, HA and Botox help in alleviating Knee pain, improving functionality of the joint and simultaneously improving quality of life of the patients with knee osteoarthritis, we intended to compare the efficacy of intra-articular PRP with HA (because of their synergistic effect) and Botox and HA in reducing the knee pain and functional limitation of the knee and also to assess the effect of patient factors post procedure like, weight reduction and regular physiotherapy on knee pain and functional limitation of the knee . Hence the need for the study.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 40.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Bilateral Knee Osteoarthritis Grade 3 and
- •2.Knee pain> 3 months.
- •3.Morning stiffness < 30 minutes.
Exclusion Criteria
- •1.Patient’s unwillingness to participate.
- •2.History of other diseases affecting knee joint like Rheumatoid Arthritis, Gout, Neuromuscular diseases.
- •3.Previous intra-articular injections.
- •4.History of knee joint surgery.
- •5.Acute Trauma.
- •6.Contraindications to intra-articular injection e.g., sepsis, intra-articular infections, intra-articular fracture, or uncontrolled coagulopathy.
Outcomes
Primary Outcomes
1.To evaluate the efficacy of intra- articular Platelet rich plasma with Hyaluronic Acid (PRP with HA) in comparison with intra- articular Botulinum Toxin A with Hyaluronic Acid on knee pain.
Time Frame: Pre- Procedural, Immediate post procedure, 2weeks, 4 weeks, 12 weeks and 24 weeks.
2.To evaluate the effect of intra- articular PRP with HA in comparison with intra- articular Botulinum Toxin A with Hyaluronic Acid on functional limitation of Knee.
Time Frame: Pre- Procedural, Immediate post procedure, 2weeks, 4 weeks, 12 weeks and 24 weeks.
3.To assess the effect of patient factors post procedure, on knee pain & functional limitation .
Time Frame: Pre- Procedural, Immediate post procedure, 2weeks, 4 weeks, 12 weeks and 24 weeks.
Secondary Outcomes
- To assess the effect of patient factors post procedure, on knee pain & functional limitation .(Baseline, At the end of 24 weeks.)