Wrist Denervation vs Exercise in Wrist Osteoarthritis

Osteoarthritis Wrist Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06098586
• Other study ID #: 2023-04885-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: November 15, 2027

Study information

• Verified date: October 2023
• Source: Karolinska Institutet
• Contact: Elin Swärd
• Phone: +4612360000
• Email: elin.sward[@]regionstockholm.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: November 15, 2027
• Est. primary completion date: November 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis Wrist

Intervention

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.

Procedure:
• Partial wrist denervation
AIN and PIN neurectomy through a dorsal approach as described by Berger (Berger, 1998).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PRWE	Patient Rated Wrist Evaluation (PRWE) score (0-100 (high score worse outcome)) (MacDermid et al., 1998)	12 months
Secondary	PRWE	Patient Rated Wrist Evaluation (PRWE) score (0-100 (high score worse outcome)) (MacDermid et al., 1998)	3 months
Secondary	PRWE	Patient Rated Wrist Evaluation (PRWE) score (0-100 (high score worse outcome)) (MacDermid et al., 1998)	6 months
Secondary	PRWE	Patient Rated Wrist Evaluation (PRWE) score (0-100 (high score worse outcome)) (MacDermid et al., 1998)	5 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	EQ5D	EQ-5D-5L (0-1 (higher score better outcome)) (Brooks, 1996)	3 months
Secondary	EQ5D	EQ-5D-5L (0-1 (higher score better outcome)) (Brooks, 1996)	6 months
Secondary	EQ5D	EQ-5D-5L (0-1 (higher score better outcome)) (Brooks, 1996)	12 months
Secondary	EQ5D	EQ-5D-5L (0-1 (higher score better outcome)) (Brooks, 1996)	5 years
Secondary	GROC	Global rating of change (GROC, -5-+5, higher score better outcome)	3 months
Secondary	GROC	Global rating of change (GROC, -5-+5, higher score better outcome)	6 months
Secondary	GROC	Global rating of change (GROC, -5-+5, higher score better outcome)	12 months
Secondary	GROC	Global rating of change (GROC, -5-+5, higher score better outcome)	5 years
Secondary	Pain catastrophizing	PCS (Pain catastrophizing scale, 0-52, higher score worse outcome) (Sullivan et al, 1995)	3 months
Secondary	Pain catastrophizing	PCS (Pain catastrophizing scale, 0-52, higher score worse outcome) (Sullivan et al, 1995)	6 months
Secondary	Pain catastrophizing	PCS (Pain catastrophizing scale, 0-52, higher score worse outcome) (Sullivan et al, 1995)	12 months
Secondary	Pain catastrophizing	PCS (Pain catastrophizing scale, 0-52, higher score worse outcome) (Sullivan et al, 1995)	5 years
Secondary	ROM	Range of motion (ROM) of the wrist.	3 months
Secondary	ROM	Range of motion (ROM) of the wrist.	6 months
Secondary	ROM	Range of motion (ROM) of the wrist.	12 months
Secondary	ROM	Range of motion (ROM) of the wrist.	5 years
Secondary	Grip	Grip strength (Jamar).	3 months
Secondary	Grip	Grip strength (Jamar).	6 months
Secondary	Grip	Grip strength (Jamar).	12 months
Secondary	Grip	Grip strength (Jamar).	5 years
Secondary	Complications	Complications related to treatment	3 months
Secondary	Complications	Complications related to treatment	6 months
Secondary	Complications	Complications related to treatment	12 months
Secondary	Complications	Complications related to treatment	5 years
Secondary	Radiology	Radiological grade of osteoarthritis 5 years after inclusion compared to baseline.	5 years
Secondary	Cost	Differences in direct costs associated with treatment and indirect costs.	12 months
Secondary	sick leave	length of sick leave	12 months
Secondary	work	ability to return to previous work	12 months