A study to compare 2 injection treatments in knee osteoarthritis, that is, Platelet Rich Plasma (derived from own blood) and Adalimumab (drug) injection into knee joint to find out improvement in pain, betterment of quality of life and improvement in performing activities of daily living.
- Conditions
- Health Condition 1: M179- Osteoarthritis of knee, unspecified
- Registration Number
- CTRI/2023/07/055429
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
INCLUSION CRITERIA :
1.Patients diagnosed with OA of knee based on American College of Rheumatology
criteria
2.Radiologic KL grade II & III
3. VAS Score > 40
4. Patients not showing improvement with conservative treatment using NSAIDs for 3
months
5.Patients willing for follow up
EXCLUSION CRITERIA :
1. Patients with cognitive impairment and psychiatric disorders
2. Local site infections
3. Uncontrolled diabetes
4.Presence of other rheumatologic conditions, autoimmune diseases and collagen
vascular disease
5.Coagulation disorders and disorders affecting platelet
6. Active and latent tuberculosis
7. History of active, recurrent or chronic infections
8. Congestive heart failure (NYHA class III and IV)
9. Immunocompromised (HIV, Patients on immunosuppresants, transplant recipients)
10. Previous use of TNF alpha inhibitors for Knee OA
11. Platelet <1,50,000/microlitre
12. Prior knee injections (like cortcosteroid, HA or prolotherapy) in past 3 months
13. Previous knee surgery
14..Use of systemic steroids within past 3 months
15. Malignancy
16. Pregnancy and lactation
17. Individuals who refused to participate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome measures included were changes in : <br/ ><br> <br/ ><br>1. Pain intensity measured with VAS score <br/ ><br>Secondary outcome measures included were improvement in : <br/ ><br>1. Quality of life and activities of daily living measured with the help of KOOS scale at baseline, 6 <br/ ><br>weeks, 3 months and 6 months post injection.Timepoint: Primary outcome measures included were changes in : <br/ ><br> <br/ ><br>1. Pain intensity measured with VAS score <br/ ><br>Secondary outcome measures included were improvement in : <br/ ><br>1. Quality of life and activities of daily living measured with the help of KOOS scale at baseline, 6 <br/ ><br>weeks, 3 months and 6 months post injection.
- Secondary Outcome Measures
Name Time Method o secondary outcome measuredTimepoint: Not applicable