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NCT Number: NCT06098586

Wrist Denervation Vs Exercise in Wrist Osteoarthritis

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of hand surgery, Malmo university hospital, Malmö, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Self-managed exercise therapy program

Behavioral

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

Procedure

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

Primary outcomes

  1. PRWE

    Time frame: 6 months

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

Secondary outcomes

  1. PRWE

    Time frame: 3 months

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

  2. PRWE

    Time frame: 12 months

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

  3. PRWE

    Time frame: 5 years

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

  4. Pain NRS

    Time frame: 3 months

    Pain at rest and on load measured by a Numerical Rating Scale (NRS, 0-100 (higher score worse outcome) (Salaffi et al 2004)

  5. Pain NRS

    Time frame: 6 months

    Pain at rest and on load measured by a Numerical Rating Scale (NRS, 0-100 (higher score worse outcome) (Salaffi et al 2004)

  6. Pain NRS

    Time frame: 12 months

    Pain at rest and on load measured by a Numerical Rating Scale (NRS, 0-100 (higher score worse outcome) (Salaffi et al 2004)

  7. Pain NRS

    Time frame: 5 years

    Pain at rest and on load measured by a Numerical Rating Scale (NRS, 0-100 (higher score worse outcome) (Salaffi et al 2004)

  8. EQ5D

    Time frame: 3 months

    EQ-5D-5L (0-1 (higher score better outcome)) (Brooks, 1996)

  9. EQ5D

    Time frame: 6 months

    EQ-5D-5L (0-1 (higher score better outcome)) (Brooks, 1996)

  10. EQ5D

    Time frame: 12 months

    EQ-5D-5L (0-1 (higher score better outcome)) (Brooks, 1996)

  11. EQ5D

    Time frame: 5 years

    EQ-5D-5L (0-1 (higher score better outcome)) (Brooks, 1996)

  12. GROC

    Time frame: 3 months

    Global rating of change (GROC, -5-+5, higher score better outcome)

  13. GROC

    Time frame: 6 months

    Global rating of change (GROC, -5-+5, higher score better outcome)

  14. GROC

    Time frame: 12 months

    Global rating of change (GROC, -5-+5, higher score better outcome)

  15. GROC

    Time frame: 5 years

    Global rating of change (GROC, -5-+5, higher score better outcome)

  16. Pain catastrophizing

    Time frame: 3 months

    PCS (Pain catastrophizing scale, 0-52, higher score worse outcome) (Sullivan et al, 1995)

  17. Pain catastrophizing

    Time frame: 6 months

    PCS (Pain catastrophizing scale, 0-52, higher score worse outcome) (Sullivan et al, 1995)

  18. Pain catastrophizing

    Time frame: 12 months

    PCS (Pain catastrophizing scale, 0-52, higher score worse outcome) (Sullivan et al, 1995)

  19. Pain catastrophizing

    Time frame: 5 years

    PCS (Pain catastrophizing scale, 0-52, higher score worse outcome) (Sullivan et al, 1995)

  20. ROM

    Time frame: 3 months

    Range of motion (ROM) of the wrist.

  21. ROM

    Time frame: 6 months

    Range of motion (ROM) of the wrist.

  22. ROM

    Time frame: 12 months

    Range of motion (ROM) of the wrist.

  23. ROM

    Time frame: 5 years

    Range of motion (ROM) of the wrist.

  24. Grip

    Time frame: 3 months

    Grip strength (Jamar).

  25. Grip

    Time frame: 6 months

    Grip strength (Jamar).

  26. Grip

    Time frame: 12 months

    Grip strength (Jamar).

  27. Grip

    Time frame: 5 years

    Grip strength (Jamar).

  28. Complications

    Time frame: 3 months

    Complications related to treatment

  29. Complications

    Time frame: 6 months

    Complications related to treatment

  30. Complications

    Time frame: 12 months

    Complications related to treatment

  31. Complications

    Time frame: 5 years

    Complications related to treatment

  32. Radiology

    Time frame: 5 years

    Radiological grade of osteoarthritis 5 years after inclusion compared to baseline.

  33. Cost

    Time frame: 12 months

    Differences in direct costs associated with treatment and indirect costs.

  34. sick leave

    Time frame: 12 months

    length of sick leave

  35. work

    Time frame: 12 months

    ability to return to previous work

  36. Survival

    Time frame: 12 months

    Success of the intervention, i.e no additional surgery during the study period due to lack of treatment effect or recurrence of symptoms.

  37. Survival

    Time frame: 5 years

    Success of the intervention, i.e no additional surgery during the study period due to lack of treatment effect or recurrence of symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Elin Swärd, MD, PhD

CONTACT

[email protected]

+4612360000

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Oct 24, 2023
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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