Health TrialsbyHealthPanel

Wrist Denervation Vs Exercise in Wrist Osteoarthritis

ConditionOsteoarthritis Wrist
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKarolinska Institutet

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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/Surgery

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

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Self-managed exercise therapy programActive comparator 1 intervention
Group B: Partial wrist denervationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

PRWE

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

Time frame
6 months

Secondary outcomes

1

PRWE

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

Time frame
3 months
2

PRWE

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

Time frame
12 months
3

PRWE

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

Time frame
5 years
4

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)

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Karolinska Institutet

Lead sponsor

Source ClinicalTrials.gov
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