A Study on the Effect of Platelet Rich Plasma (PRP) on Osteoarthritis in the Thumb Base

Study Overview
=================
Brief Summary
-----------------
Randomized comparison between Platelet Rich Plasma (PRP) and placebo (Saline) for thumb base.osteoarthritis.

Official Title
-----------------
A Study on the Effect of Platelet Rich Plasma (PRP) on Osteoarthritis in the Thumb Base

Conditions
-----------------
Thumb Osteoarthritis

Intervention / Treatment
-----------------
* Other: PRP
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Arthritis 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 pseudo gout. Inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction). Intra-articular injection in the affected joint within 6 months. Eaton Littler class 4 (STT joint involved).
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PRP<br>Intra-articular injection PRP | Other: PRP<br>* Platelet rich plasma<br>|
| Placebo Comparator: Saline<br>Intra-articular injection Saline | Other: Placebo<br>* Saline<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient-rated pain on load | Numerical rating scale 0-10p (10=worst possible pain). | 3 and 6 months after injection. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Nelson Thumb score | Patient Rated Outcome Measure, 0-100p, lower score= more disability | 3 and 6 months after injection. | 
| Change in EQ-5D | Weight mean value: 0=dead, 1= healthy | 3 and 6 months after injection. | 
| Change in Patient-rated Wrist and Hand Evaluation (PRWHE) | Patient Rated Outcome Measure 0-100p, higher score=more disability | 3 and 6 months after injection. | 
| Change in Disability of the Hand, Arm and Shoulder (DASH) score | Patient Rated Outcome Measure, 0-100p higher score=more disability | 3 and 6 months after injection. | 
| Change in Hospital Anxiety and Depression Score (HADS), | 2 subscores for anxiety (0-21p) and depression (0-21p), higher score = worse | 3 and 6 months after injection. | 
| Change in Pain Catastrophizing Score (PCS). | 0-52p, higher score = more pain catastrophizing | 3 and 6 months after injection. | 
| Change in thumb range of motion | Radial and palmar abduction of the first metacarpal (degrees) | 3 and 6 months after injection. | 
| Change in thumb strength | Key pinch and pinch strength (Kg) | 3 and 6 months after injection. |