Wrist Denervation vs Exercise in Wrist Osteoarthritis

Study Overview
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Brief Summary
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A randomized controlled trial comparing partial wrist denervation to a self-managed exercise therapy program in 140 patients with wrist osteoarthritis.

Detailed Description
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Backgroud: High quality evidence regarding the effectiveness of non-operative and operative treatments in wrist osteoarthritis are lacking. Aim: To analyze: Does partial wrist denervation and self-managed exercise therapy improve patient-reported outcomes, pain, grip strength and range of motion (ROM) in wrist OA? Is any of the two treatment concepts partial wrist denervation and self-managed exercise therapy more efficient than the other in terms of patient-reported outcomes, pain relief, grip strength and range of motion? Method: A multicenter parallel group, two-arm, randomized, controlled, assessor blinded, trial of 140 patients. The study is conducted at the departments of hand surgery at Södersjukhuset Stockholm and Malmö University hospital. Group1: Self-managed exercise therapy program containing: Patient education: Exercise therapy program: The exercise therapy program is designed by Sara Larsson (physiotherapist at the Department of hand surgery in Malmö, Sweden), influenced by previous studies on wrist stability and proprioception. Focus is on functional re-learning and strengthening of the musculoskeletal system with the aim to create a stable wrist that can be used in a pain-free manner in activities of daily living. The program consists of neuromuscular exercises that focus on coordination, wrist stability and strength. Group 2: Surgery will be performed under local anesthesia (+ blood-less field or wide-awake local anesthesia no torniquet (WALANT) according to the surgeon's preference) through a single dorsal incision. AIN and PIN neurectomy will be performed as described by Berger (Berger, 1998). Primary outcome: Patient Rated Wrist Evaluation (PRWE) score (0-100) (MacDermid et al., 1998) 12 months after intervention.

Official Title
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Partial Wrist Denervation Versus Self-managed Exercise Therapy in Patients With Wrist Osteoarthritis: A Randomized Controlled Multicenter Trial

Conditions
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Osteoarthritis Wrist

Intervention / Treatment
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* Behavioral: Self-managed exercise therapy program
* Procedure: Partial wrist denervation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years. Chronic wrist pain (≥6 months) due to Scapholunate advanced collapse (SLAC) / Scaphoid non-union advanced collapse (SNAC) grade 1-3 osteoarthritis. Radiological signs of osteoarthritis on posteroanterior and lateral radiograph. Exclusion Criteria: Previous PIN or AIN neurectomy. Rheumatoid arthritis or other chronic inflammatory arthritis. Symptomatic osteoarthritis in the distal radio-ulnar (DRU), Scapho-trapezio-trapezoid (STT) or thumb carpometacarpal (CMC) joints. Ongoing infection. Inability to co-operate with the follow-up protocol. Systemic or intra-articular glucocorticoids or intraarticular PRP or Hyaluronic acid injections in the affected joint within 3 months prior to enrollment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Self-managed exercise therapy program<br>Exercise program focusing on functional re-learning and strengthening of the musculoskeletal system with the aim to create a stable wrist that can be used in a pain-free manner in activities of daily living. | Behavioral: Self-managed exercise therapy program<br>* Exercise program focusing on functional re-learning and strengthening of the musculoskeletal system with the aim to create a stable wrist that can be used in a pain-free manner in activities of daily living.<br>|
| Active Comparator: Partial wrist denervation<br>AIN and PIN neurectomy through a dorsal approach as described by Berger (Berger, 1998). | Procedure: Partial wrist denervation<br>* AIN and PIN neurectomy through a dorsal approach as described by Berger (Berger, 1998).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PRWE | Patient Rated Wrist Evaluation (PRWE) score (0-100 (high score worse outcome)) (MacDermid et al., 1998) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PRWE | Patient Rated Wrist Evaluation (PRWE) score (0-100 (high score worse outcome)) (MacDermid et al., 1998) | 3 months | 
| PRWE | Patient Rated Wrist Evaluation (PRWE) score (0-100 (high score worse outcome)) (MacDermid et al., 1998) | 6 months | 
| PRWE | Patient Rated Wrist Evaluation (PRWE) score (0-100 (high score worse outcome)) (MacDermid et al., 1998) | 5 years | 
| Pain NRS | Pain at rest and on load measured by a Numerical Rating Scale (NRS, 0-100 (higher score worse outcome) (Salaffi et al 2004) | 3 months | 
| Pain NRS | Pain at rest and on load measured by a Numerical Rating Scale (NRS, 0-100 (higher score worse outcome) (Salaffi et al 2004) | 6 months | 
| Pain NRS | Pain at rest and on load measured by a Numerical Rating Scale (NRS, 0-100 (higher score worse outcome) (Salaffi et al 2004) | 12 months | 
| Pain NRS | Pain at rest and on load measured by a Numerical Rating Scale (NRS, 0-100 (higher score worse outcome) (Salaffi et al 2004) | 5 years | 
| EQ5D | EQ-5D-5L (0-1 (higher score better outcome)) (Brooks, 1996) | 3 months | 
| EQ5D | EQ-5D-5L (0-1 (higher score better outcome)) (Brooks, 1996) | 6 months | 
| EQ5D | EQ-5D-5L (0-1 (higher score better outcome)) (Brooks, 1996) | 12 months | 
| EQ5D | EQ-5D-5L (0-1 (higher score better outcome)) (Brooks, 1996) | 5 years | 
| GROC | Global rating of change (GROC, -5-+5, higher score better outcome) | 3 months | 
| GROC | Global rating of change (GROC, -5-+5, higher score better outcome) | 6 months | 
| GROC | Global rating of change (GROC, -5-+5, higher score better outcome) | 12 months | 
| GROC | Global rating of change (GROC, -5-+5, higher score better outcome) | 5 years | 
| Pain catastrophizing | PCS (Pain catastrophizing scale, 0-52, higher score worse outcome) (Sullivan et al, 1995) | 3 months | 
| Pain catastrophizing | PCS (Pain catastrophizing scale, 0-52, higher score worse outcome) (Sullivan et al, 1995) | 6 months | 
| Pain catastrophizing | PCS (Pain catastrophizing scale, 0-52, higher score worse outcome) (Sullivan et al, 1995) | 12 months | 
| Pain catastrophizing | PCS (Pain catastrophizing scale, 0-52, higher score worse outcome) (Sullivan et al, 1995) | 5 years | 
| ROM | Range of motion (ROM) of the wrist. | 3 months | 
| ROM | Range of motion (ROM) of the wrist. | 6 months | 
| ROM | Range of motion (ROM) of the wrist. | 12 months | 
| ROM | Range of motion (ROM) of the wrist. | 5 years | 
| Grip | Grip strength (Jamar). | 3 months | 
| Grip | Grip strength (Jamar). | 6 months | 
| Grip | Grip strength (Jamar). | 12 months | 
| Grip | Grip strength (Jamar). | 5 years | 
| Complications | Complications related to treatment | 3 months | 
| Complications | Complications related to treatment | 6 months | 
| Complications | Complications related to treatment | 12 months | 
| Complications | Complications related to treatment | 5 years | 
| Radiology | Radiological grade of osteoarthritis 5 years after inclusion compared to baseline. | 5 years | 
| Cost | Differences in direct costs associated with treatment and indirect costs. | 12 months | 
| sick leave | length of sick leave | 12 months | 
| work | ability to return to previous work | 12 months |