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Wrist Denervation vs Exercise in Wrist Osteoarthritis: A Multicenter RCT

Primary Purpose

Osteoarthritis Wrist

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Self-managed exercise therapy program
Partial wrist denervation
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis Wrist

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Self-managed exercise therapy program

    Partial wrist denervation

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    PRWE
    Patient Rated Wrist Evaluation (PRWE) score (0-100) (MacDermid et al., 1998)
    PRWE
    Patient Rated Wrist Evaluation (PRWE) score (0-100) (MacDermid et al., 1998)
    PRWE
    Patient Rated Wrist Evaluation (PRWE) score (0-100) (MacDermid et al., 1998)
    Pain NRS
    Pain at rest and on load measured by a Numerical Rating Scale (NRS) (Salaffi et al 2004)
    Pain NRS
    Pain at rest and on load measured by a Numerical Rating Scale (NRS) (Salaffi et al 2004)
    Pain NRS
    Pain at rest and on load measured by a Numerical Rating Scale (NRS) (Salaffi et al 2004)
    Pain NRS
    Pain at rest and on load measured by a Numerical Rating Scale (NRS) (Salaffi et al 2004)
    EQ5D
    EQ-5D-5L (0-1) (Brooks, 1996)
    EQ5D
    EQ-5D-5L (0-1) (Brooks, 1996)
    EQ5D
    EQ-5D-5L (0-1) (Brooks, 1996)
    EQ5D
    EQ-5D-5L (0-1) (Brooks, 1996)
    GROC
    Global rating of change (GROC)
    GROC
    Global rating of change (GROC)
    GROC
    Global rating of change (GROC)
    GROC
    Global rating of change (GROC)
    Pain catastrophizing
    PCS (Pain catastrophizing scale) (Sullivan et al, 1995)
    Pain catastrophizing
    PCS (Pain catastrophizing scale) (Sullivan et al, 1995)
    Pain catastrophizing
    PCS (Pain catastrophizing scale) (Sullivan et al, 1995)
    Pain catastrophizing
    PCS (Pain catastrophizing scale) (Sullivan et al, 1995)
    ROM
    Range of motion (ROM) of the wrist.
    ROM
    Range of motion (ROM) of the wrist.
    ROM
    Range of motion (ROM) of the wrist.
    ROM
    Range of motion (ROM) of the wrist.
    Grip
    Grip strength (Jamar).
    Grip
    Grip strength (Jamar).
    Grip
    Grip strength (Jamar).
    Grip
    Grip strength (Jamar).
    Complications
    Complications related to treatment
    Complications
    Complications related to treatment
    Complications
    Complications related to treatment
    Complications
    Complications related to treatment
    Radiology
    Radiological grade of osteoarthritis 5 years after inclusion compared to baseline.
    Cost
    Differences in direct costs associated with treatment and indirect costs.
    work
    length of sick leave, ability to return to previous work

    Full Information

    First Posted
    October 18, 2023
    Last Updated
    October 18, 2023
    Sponsor
    Karolinska Institutet
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06098586
    Brief Title
    Wrist Denervation vs Exercise in Wrist Osteoarthritis: A Multicenter RCT
    Official Title
    Partial Wrist Denervation Versus Self-managed Exercise Therapy in Patients With Wrist Osteoarthritis: A Randomized Controlled Multicenter Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 15, 2023 (Anticipated)
    Primary Completion Date
    November 15, 2026 (Anticipated)
    Study Completion Date
    November 15, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Karolinska Institutet

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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: Does partial wrist denervation and self-managed exercise therapy improve patient-reported outcomes, pain, grip strength and range of motion (ROM) in wrist OA? 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis Wrist

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Masking Description
    Data assessors and analysts will be masked for treatment allocation (covered wrist / anonymous data sheet).
    Allocation
    Randomized
    Enrollment
    140 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Self-managed exercise therapy program
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Partial wrist denervation
    Arm Type
    Active Comparator
    Arm Description
    AIN and PIN neurectomy through a dorsal approach as described by Berger (Berger, 1998).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Self-managed exercise therapy program
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Partial wrist denervation
    Intervention Description
    AIN and PIN neurectomy through a dorsal approach as described by Berger (Berger, 1998).
    Primary Outcome Measure Information:
    Title
    PRWE
    Description
    Patient Rated Wrist Evaluation (PRWE) score (0-100) (MacDermid et al., 1998)
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    PRWE
    Description
    Patient Rated Wrist Evaluation (PRWE) score (0-100) (MacDermid et al., 1998)
    Time Frame
    3 months
    Title
    PRWE
    Description
    Patient Rated Wrist Evaluation (PRWE) score (0-100) (MacDermid et al., 1998)
    Time Frame
    6 months
    Title
    PRWE
    Description
    Patient Rated Wrist Evaluation (PRWE) score (0-100) (MacDermid et al., 1998)
    Time Frame
    5 years
    Title
    Pain NRS
    Description
    Pain at rest and on load measured by a Numerical Rating Scale (NRS) (Salaffi et al 2004)
    Time Frame
    3 months
    Title
    Pain NRS
    Description
    Pain at rest and on load measured by a Numerical Rating Scale (NRS) (Salaffi et al 2004)
    Time Frame
    6 months
    Title
    Pain NRS
    Description
    Pain at rest and on load measured by a Numerical Rating Scale (NRS) (Salaffi et al 2004)
    Time Frame
    12 months
    Title
    Pain NRS
    Description
    Pain at rest and on load measured by a Numerical Rating Scale (NRS) (Salaffi et al 2004)
    Time Frame
    5 years
    Title
    EQ5D
    Description
    EQ-5D-5L (0-1) (Brooks, 1996)
    Time Frame
    3 months
    Title
    EQ5D
    Description
    EQ-5D-5L (0-1) (Brooks, 1996)
    Time Frame
    6 months
    Title
    EQ5D
    Description
    EQ-5D-5L (0-1) (Brooks, 1996)
    Time Frame
    12 months
    Title
    EQ5D
    Description
    EQ-5D-5L (0-1) (Brooks, 1996)
    Time Frame
    5 years
    Title
    GROC
    Description
    Global rating of change (GROC)
    Time Frame
    3 months
    Title
    GROC
    Description
    Global rating of change (GROC)
    Time Frame
    6 months
    Title
    GROC
    Description
    Global rating of change (GROC)
    Time Frame
    12 months
    Title
    GROC
    Description
    Global rating of change (GROC)
    Time Frame
    5 years
    Title
    Pain catastrophizing
    Description
    PCS (Pain catastrophizing scale) (Sullivan et al, 1995)
    Time Frame
    3 months
    Title
    Pain catastrophizing
    Description
    PCS (Pain catastrophizing scale) (Sullivan et al, 1995)
    Time Frame
    6 months
    Title
    Pain catastrophizing
    Description
    PCS (Pain catastrophizing scale) (Sullivan et al, 1995)
    Time Frame
    12 months
    Title
    Pain catastrophizing
    Description
    PCS (Pain catastrophizing scale) (Sullivan et al, 1995)
    Time Frame
    5 years
    Title
    ROM
    Description
    Range of motion (ROM) of the wrist.
    Time Frame
    3 months
    Title
    ROM
    Description
    Range of motion (ROM) of the wrist.
    Time Frame
    6 months
    Title
    ROM
    Description
    Range of motion (ROM) of the wrist.
    Time Frame
    12 months
    Title
    ROM
    Description
    Range of motion (ROM) of the wrist.
    Time Frame
    5 years
    Title
    Grip
    Description
    Grip strength (Jamar).
    Time Frame
    3 months
    Title
    Grip
    Description
    Grip strength (Jamar).
    Time Frame
    6 months
    Title
    Grip
    Description
    Grip strength (Jamar).
    Time Frame
    12 months
    Title
    Grip
    Description
    Grip strength (Jamar).
    Time Frame
    5 years
    Title
    Complications
    Description
    Complications related to treatment
    Time Frame
    3 months
    Title
    Complications
    Description
    Complications related to treatment
    Time Frame
    6 months
    Title
    Complications
    Description
    Complications related to treatment
    Time Frame
    12 months
    Title
    Complications
    Description
    Complications related to treatment
    Time Frame
    5 years
    Title
    Radiology
    Description
    Radiological grade of osteoarthritis 5 years after inclusion compared to baseline.
    Time Frame
    5 years
    Title
    Cost
    Description
    Differences in direct costs associated with treatment and indirect costs.
    Time Frame
    12 months
    Title
    work
    Description
    length of sick leave, ability to return to previous work
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Elin Swärd
    Phone
    +4612360000
    Email
    elin.sward@regionstockholm.se
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Elin Swärd
    Organizational Affiliation
    Karolinska Institutet
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Wrist Denervation vs Exercise in Wrist Osteoarthritis: A Multicenter RCT

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