Clinical trial NCT06098586: Wrist Denervation Vs Exercise in Wrist Osteoarthritis
Official title: Partial Wrist Denervation Versus Self-managed Exercise Therapy in Patients with Wrist Osteoarthritis: a Randomized Controlled Multicenter Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis Wrist
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2023-10-24
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: PRWE
timeFrame: 6 months
Secondary outcomes:
measure: PRWE
timeFrame: 3 months
measure: PRWE
timeFrame: 12 months
measure: PRWE
timeFrame: 5 years
measure: Pain NRS
timeFrame: 3 months
measure: Pain NRS
timeFrame: 6 months
measure: Pain NRS
timeFrame: 12 months
measure: Pain NRS
timeFrame: 5 years
measure: EQ5D
timeFrame: 3 months
measure: EQ5D
timeFrame: 6 months
measure: EQ5D
timeFrame: 12 months
measure: EQ5D
timeFrame: 5 years
measure: GROC
timeFrame: 3 months
measure: GROC
timeFrame: 6 months
measure: GROC
timeFrame: 12 months
measure: GROC
timeFrame: 5 years
measure: Pain catastrophizing
timeFrame: 3 months
measure: Pain catastrophizing
timeFrame: 6 months
measure: Pain catastrophizing
timeFrame: 12 months
measure: Pain catastrophizing
timeFrame: 5 years
measure: ROM
timeFrame: 3 months
measure: ROM
timeFrame: 6 months
measure: ROM
timeFrame: 12 months
measure: ROM
timeFrame: 5 years
measure: Grip
timeFrame: 3 months
measure: Grip
timeFrame: 6 months
measure: Grip
timeFrame: 12 months
measure: Grip
timeFrame: 5 years
measure: Complications
timeFrame: 3 months
measure: Complications
timeFrame: 6 months
measure: Complications
timeFrame: 12 months
measure: Complications
timeFrame: 5 years
measure: Radiology
timeFrame: 5 years
measure: Cost
timeFrame: 12 months
measure: sick leave
timeFrame: 12 months
measure: work
timeFrame: 12 months
measure: Survival
timeFrame: 12 months
measure: Survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Malmo
country: Sweden
facility: Department of hand surgery, Malmo university hospital
city: Stockholm
country: Sweden
facility: Department of hand handsurgery, Södersjukhuset
Study officials:
affiliation: Karolinska Institutet
name: Elin Swärd, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: