Denervation for Osteoarthritis in the PIP-joint Efficacy Study (DOPS), a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Karolinska Institutet
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Pain on load (change baseline to -12 months)
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Data analysts will be masked for treatment allocation
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Surgical treatment
PIP joint denervation is performed through a volar approach.
Intervention: PIP joint denervation (Procedure)
Non-surgical treatment
An education and exercise program.
Intervention: Patient education plus exercise (Procedure)
Outcomes
Primary Outcomes
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
- Complications(0-12 months)
- Objective function change baseline to -3, -6, -12 months(0-12 months)
- EQ5D-5L change baseline to -3, -6, -12 months(0-12 months)
- HQ8 (8-item patient questionnaire) change baseline to -3, -6, 12 months(0-12 months)
- PRWHE (Patient Rated Wrist/Hand Evaluation) change baseline to -3, 6, 12 months(0-12 months)
- Pain at rest (change baseline to -3, -6, -12 months)(0-12 months)
- Additional treatment(0-12 months)
Investigators
Elin Swärd
MD, PhD
Karolinska Institutet