Health TrialsbyHealthPanel

Denervation for Osteoarthritis in the PIP-joint Efficacy Study (DOPS)

ConditionsOsteoarthritis FingerSurgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKarolinska Institutet

About this trial

The goal of this clinical trial is to compare the effects of a surgical and a non-surgical treatment method in patients with osteoarthritis in the proximal interphalangeal (PIP) joint. The main questions it aims to answer are:

* Are the treatments effective? * Is the surgical treatment more effective than the non-surgical treatment? Participants will receive surgical treatment (PIP joint denervation) or non surgical treatment (patient education plus exercise).

Researchers will compare the non-surgical and surgical groups to see if pain, patient-reported function, quality of life, movement and grip strength differs between the groups.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years.

Chronic symptomatic osteoarthritis in the PIP-joint.

Radiological signs of osteoarthritis on posteroanterior and lateral radiographs assessed by the Kellgren-Lawrence classification (grade II-IV) (Kellgren & Lawrence, 1957).

Clinical signs of PIP-joint arthritis.

Disqualifiers

Inflammatory arthritis.

Ongoing infection in the hand.

Inability to co-operate with the follow-up protocol.

Intra-articular glucocorticoid, PRP or Hyaluronic acid injections in the affected joint less than 3 months prior to enrollment.

Trial design

Design model

Parallel

Treatments tested in this trial

  • PIP joint denervation

    Procedure/Surgery

    Surgical denervation of the PIP joint

  • Patient education plus exercise

    Procedure/Surgery

    An education plus exercise program

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Surgical treatmentActive comparator 1 intervention
Group B: Non-surgical treatmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain on load (change baseline to -12 months)

Pain (Numerical Rating Scale, 0-100 points, 100 is a worse outcome)

Time frame
0-12 months

Secondary outcomes

1

Pain at rest (change baseline to -3, -6, -12 months)

Pain (Numerical Rating Scale, 0-100 points, 100 is a worse outcome)

Time frame
0-12 months
2

HQ8 (8-item patient questionnaire) change baseline to -3, -6, 12 months

A questionnaire used by Swedish Healthcare Quality Registry for hand surgery (HAKIR), 0-100 points, 100 is a worse outcome.

Time frame
0-12 months
3

PRWHE (Patient Rated Wrist/Hand Evaluation) change baseline to -3, 6, 12 months

A questionnaire that measures hand/wrist function (0-100 points, 100 is a worse outcome)

Time frame
0-12 months
4

EQ5D-5L change baseline to -3, -6, -12 months

A questionnaire that measures quality of life (0-1 point, 0 is a worse outcome).

Time frame
0-12 months

Other outcomes

Sponsors and contacts

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

Karolinska Institutet

Lead sponsor

Stockholm South General Hospital

Collaborator

Source ClinicalTrials.gov
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