Effectiveness of ultrasound guided intraarticular injection of platelet rich plasma compared with triamcinolone hexacetonide in improvement of pain and function in patients with adhesive capsulitis: A randomized controlled trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Shoulder Pain and Function in terms of Shoulder Pain and Disability Index (SPADI)
Study Overview
Brief Summary
This study is a randomized, parallel group, active control trial comparing the effectiveness of ultrasound guided intra articular injection of 4ml Platelet rich plasma with 1 ml triamcinolone hexacetonide 20mg/ml in improvement of pain and function in 64 patients with adhesive capsulitis of shoulder. This study will be conducted in Department of Physical Medicine and Rehabilitation , Regional Institute of Medical Sciences, Imphal, Manipur in India. The primary outcome measures will be improvement in pain and function as measured by SPADI and secondary outcome measures will be pain measured by VAS and shoulder function measured by Range of motion which all will be asses at 1week, 4weeks, 12 weeks and 24 weeks post intervention.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 40.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Diagnosed case of adhesive capsulitis, Patients who are willing to comply with the study and follow up assessments.
Exclusion Criteria
- •Patients with uncontrolled diabetes History of shoulder trauma/surgery History of injection in the shoulder joint in past three months Non-steroidal anti-inflammatory drugs intake in last seven days Coagulopathy Thrombocytopenia (1.5 lakh/microlitre) Autoimmune disorders Impaired cognition Any febrile or infectious disease (systemic & local).
Outcomes
Primary Outcomes
Shoulder Pain and Function in terms of Shoulder Pain and Disability Index (SPADI)
Time Frame: 1 week, 4 week, 12 week, 24 week
Secondary Outcomes
- Pain in terms of Visual Analogue Scale (VAS)(1 week, 4 weeks, 12 weeks, 24 weeks)
- Shoulder function in terms of Range of Motion(1 week, 4 weeks, 12 weeks, 24 weeks)