Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
140 participants
INTERVENTIONAL
2023-11-15
2027-11-15
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
Partial wrist denervation
AIN and PIN neurectomy through a dorsal approach as described by Berger (Berger, 1998).
Partial wrist denervation
AIN and PIN neurectomy through a dorsal approach as described by Berger (Berger, 1998).
Interventions
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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.
Partial wrist denervation
AIN and PIN neurectomy through a dorsal approach as described by Berger (Berger, 1998).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Karolinska Institutet
OTHER
Responsible Party
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Elin Swärd
Principal Investigator
Principal Investigators
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Elin Swärd, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
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Department of hand surgery, Malmo university hospital
Malmo, , Sweden
Department of hand handsurgery, Södersjukhuset
Stockholm, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-04885-01
Identifier Type: -
Identifier Source: org_study_id
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