Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06098586

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
140 (estimated)
Sponsor
Karolinska Institutet · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSelf-managed exercise therapy programExercise 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.
PROCEDUREPartial wrist denervationAIN and PIN neurectomy through a dorsal approach as described by Berger (Berger, 1998).

Timeline

Start date
2023-11-15
Primary completion
2026-11-15
Completion
2027-11-15
First posted
2023-10-24
Last updated
2025-02-21

Locations

2 sites across 1 country: Sweden

Source: ClinicalTrials.gov record NCT06098586. Inclusion in this directory is not an endorsement.