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NCT Number: NCT05980793

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

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.

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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, Södersjukhuset

Stockholm, Sweden

Location status: Recruiting

Location contact

Elin Swärd, MD, PhD

CONTACT

About this study

This is a parallel group, two-arm, randomized, controlled trial comparing the effects of surgical denevation to patient education plus exercise in patients with symptomatic PIP joint osteoarthritis.

The research questions are:

  • Does any of the treatments denervation of the PIP-joint and patient education plus exercise decrease pain, improve patient-reported outcomes, grip strength and range of motion (ROM) in PIP-joint osteoarthritis?
  • Does denervation of the PIP-joint decrease pain, and improve patient-reported outcomes grip strength and ROM more effectively than patient education plus exercise for PIP-joint osteoarthritis?

Participants will be randomly assigned (1:1) to receive surgical denervation of the PIP-joint or education plus exercise. A block randomization scheme with a fixed block size of 10 will be used. Patients will be stratified according to gender. Sealed opaque envelopes will be used and data analysts will be masked for treatment allocation.

Assesments will be made at inclusion, and after 3, 6 and 12 months. The studys primary enpoint is 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 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.

Exclusion criteria

  • 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.

Treatment and study plan

PIP joint denervation

Procedure

Surgical denervation of the PIP joint

Patient education plus exercise

Procedure

An education plus exercise program

Primary outcomes

  1. Pain on load (change baseline to -12 months)

    Time frame: 0-12 months

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

Secondary outcomes

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

    Time frame: 0-12 months

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

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

    Time frame: 0-12 months

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

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

    Time frame: 0-12 months

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

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

    Time frame: 0-12 months

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

  5. Objective function change baseline to -3, -6, -12 months

    Time frame: 0-12 months

    Range of motion (goniometer with 5 degrees interval)

  6. Objective function change baseline to -3, -6, -12 months

    Time frame: 0-12 months

    grip strength (hydraulic hand dynamometer, kilograms)

  7. Complications

    Time frame: 0-12 months

    2PD (Two point discrimination, 0-15mm, 15 indicating a worse outcome)

  8. Complications

    Time frame: 0-12 months

    Mini Sollerman (0-12 points, 12 indicating a better outcome)

  9. Complications

    Time frame: 0-12 months

    Infection (clinical evaluation, positive cultures, need for antibiotics)

  10. Additional treatment

    Time frame: 0-12 months

    Need for further surgery/treatment

Study contacts

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

Elin Sward, MD, PhD

CONTACT

[email protected]

+46812361000

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Stockholm South General Hospital

Registry information

Official study title

Denervation for Osteoarthritis in the PIP-joint Efficacy Study (DOPS), a Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
Aug 8, 2023
Registry last updated
Dec 2, 2024

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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