Wrist Denervation vs Exercise in Wrist Osteoarthritis

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Osteoarthritis Wrist
• Intervention / Treatment: Behavioral: Self-managed exercise therapy program; Procedure: Partial wrist denervation

Detailed Description

Backgroud:

High quality evidence regarding the effectiveness of non-operative and operative treatments in wrist osteoarthritis are lacking.

Aim:

To analyze:

1. Does partial wrist denervation and self-managed exercise therapy improve patient-reported outcomes, pain, grip strength and range of motion (ROM) in wrist OA?
2. 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.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elin Swärd; Phone Number: +4612360000; Email: elin.sward@regionstockholm.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Self-managed exercise therapy program; 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; 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.
Active Comparator: Partial wrist denervation; AIN and PIN neurectomy through a dorsal approach as described by Berger (Berger, 1998).	Procedure: Partial wrist denervation; AIN and PIN neurectomy through a dorsal approach as described by Berger (Berger, 1998).

What is the study measuring?

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
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
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
sick leave	length of sick leave	12 months
work	ability to return to previous work	12 months

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Elin Swärd, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Estimated): November 15, 2023
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 15, 2027

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: October 18, 2023
• First Posted (Actual): October 24, 2023

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 2023-04885-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No