Efficacy of denervation for osteoarthritis in the proximal interphalangeal joint (DOP): protocol of a randomized controlled trial.
Elin M Swärd, Jonas Beckman, Farnoush Tabaroj...
https://pubmed.ncbi.nlm.nih.gov/39169395Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05980793
Denervation for Osteoarthritis in the PIP-joint Efficacy Study (DOPS), a Randomized Controlled Trial
Led by Karolinska Institutet · Updated on 2024-12-02
90
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
K
Karolinska Institutet
Lead Sponsor
S
Stockholm South General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to compare surgical and non-surgical treatments in adults with osteoarthritis affecting the proximal interphalangeal (PIP) joint of the finger. The study evaluates whether these treatments reduce pain, improve patient-reported function, quality of life, movement, and grip strength. Researchers want to find out if surgical denervation is more effective than patient education combined with exercise for this condition. Participants will be randomly assigned to one of two groups: one receiving surgical denervation of the PIP joint performed through a volar approach, and the other undergoing a program of patient education plus exercise. The study uses a two-arm parallel design with block randomization and stratification by gender. The treatments and outcomes will be compared over a 12-month period. Participants will be assessed at the start, and then at 3, 6, and 12 months after treatment. Evaluations include measuring pain during load, pain at rest, patient questionnaires about wrist and hand function, quality of life surveys, and objective function tests. Researchers will also monitor complications and any additional treatments during the year. The primary outcome is the change in pain on load from baseline to 12 months.
CONDITIONS
Brief Title
Denervation for Osteoarthritis in the PIP-joint Efficacy Study (DOPS)
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 2 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)
- Clinical signs of PIP-joint arthritis
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 months
Participants receive either surgical denervation of the PIP joint or participate in an education plus exercise program to manage osteoarthritis symptoms.
1 baseline visit and 3 follow-up visits at 3, 6, and 12 months
Trial Site Locations
Total: 1 location
1
Department of Hand Surgery, Södersjukhuset
Stockholm, Sweden
Actively Recruiting
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Research Team
E
Elin Sward, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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