A Study on the Effect of High-concentrated Platelet Rich Plasma (PRP) on Osteoarthritis in the Thumb Base.
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Karolinska Institutet
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Pain on load in thumb
Overview
Brief Summary
This is a randomized double-blinded randomized comparison between injection of platelet rich plasma (PRP) and placebo for thumb basale osteoarthritis.
Detailed Description
The aim of this study is to evaluate if high-concentration PRP injection decreases pain and disability in patients with thumb base osteoarthritis in the short-term and compare the effect to placebo.90 patients will be inlcuded (45+45). The primary outcome is pain on load (numerical rating scale) after 6 months. Patient-rated outcome measures, pinch grip and key pinch, range of motion of the CMC.1 joint will be assessed before treatment and at 3, 6 and months after the injection. Participants and assessors will be blinded.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
blind fold on participants. No infomration about given treatment to outcome assessors.
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Osteoarthritis in the thumb base
- •Radiological Eaton Littler class 1-
- •Clinical signs of thumb base osteoarthritis )pain at palpation of the CMC-1 joint and pain during provocation/grinding test).
Exclusion Criteria
- •Rheumatoid arthritis
- •Ongoing infection in the hand or wrist
- •History of gout or pseudogout in the hand
- •Inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction).
- •Chronic pain syndrome / centralized pain.
- •Intra-articular injection in the affected joint within 6 months.
- •Eaton Littler class 4 (symptomatic STT joint osteoarthritis).
Outcomes
Primary Outcomes
Pain on load in thumb
Time Frame: 6 months after the first injection.
Pain on load (numerical rating scale (NRS) 0-100, higher score represents more pain)
Secondary Outcomes
- HAKIR symptom score (HQ-8)(12 months)
- Nelson thumb score(12 months)
- key pinch and pinch strength(12 months)
- Radial and palmar abduction(12 months)
- Patient-rated Wrist and Hand (PRWHE) score(12 months)
Investigators
Maria Wilcke
Associate profesoor
Karolinska Institutet