Osteoarthritis Thumb
Conditions
Keywords
CMC-1 joint, thumb basal joint, PRP, Platelet-rich plasma
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.
Interventions
PROCEDUREPlatelet rich plasma (PRP)
Intra-articular injection of platelet rich plasma (PRP)
OTHERPlacebo
Intra-articular Saline injection (0,6-1ml)
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
blind fold on participants. No infomration about given treatment to outcome assessors.
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Osteoarthritis in the thumb base * Radiological Eaton Littler class 1-3. * 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain on load in thumb | 6 months after the first injection. | Pain on load (numerical rating scale (NRS) 0-100, higher score represents more pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-rated Wrist and Hand (PRWHE) score | 3 months | 0-100, higher score represents more disability |
| Nelson thumb score | 3 months | 0-100, lower score represents more symptoms |
| HAKIR symptom score (HQ-8) | 3 months | 0-100, lower score represents more symptoms |
| key pinch and pinch strength | 3 months | key pinch and pinch strength (kg) |
| Radial and palmar abduction | 3 months | Radial and palmar abduction of the first metacarpal (degrees) |
Countries
Sweden
Contacts
Primary ContactMaria Wilcke, MD, PhD
Backup ContactJohanna VonKieseritzky, MD. PhD
Outcome results
None listed