Wrist Denervation Vs Exercise in Wrist Osteoarthritis

Karolinska Institutet140 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

140

Conditions

Osteoarthritis Wrist

Interventions

Self-managed exercise therapy programBEHAVIORAL

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.

Partial wrist denervationPROCEDURE

AIN and PIN neurectomy through a dorsal approach as described by Berger (Berger, 1998).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Department of hand surgery, Malmo university hospital

Malmo, Sweden

RECRUITING

Department of hand handsurgery, Södersjukhuset

Stockholm, Sweden

RECRUITING

Outcomes

Primary Outcomes

PRWE

Patient Rated Wrist Evaluation (PRWE) score (0-100 (high score worse outcome)) (MacDermid et al., 1998)

Time frame: 6 months

Secondary Outcomes

PRWE

Patient Rated Wrist Evaluation (PRWE) score (0-100 (high score worse outcome)) (MacDermid et al., 1998)

Time frame: 3 months

PRWE

Patient Rated Wrist Evaluation (PRWE) score (0-100 (high score worse outcome)) (MacDermid et al., 1998)

Time frame: 12 months

PRWE

Patient Rated Wrist Evaluation (PRWE) score (0-100 (high score worse outcome)) (MacDermid et al., 1998)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Central Contacts

Elin Swärd, MD, PhD

CONTACT

+4612360000 elin.sward@regionstockholm.se

Data from ClinicalTrials.gov

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