NCT05980793

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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: 1. 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? 2. 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.

Conditions

• Osteoarthritis Finger
• Surgery

Interventions

Type	Name	Description
PROCEDURE	PIP joint denervation	Surgical denervation of the PIP joint
PROCEDURE	Patient education plus exercise	An education plus exercise program

Timeline

• Start date: 2023-09-25
• Primary completion: 2028-07-15
• Completion: 2029-07-15
• First posted: 2023-08-08
• Last updated: 2024-12-02

Locations

1 site across 1 country: Sweden