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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
90
Surgical denervation of the PIP joint
An education plus exercise program
Department of Hand Surgery, Södersjukhuset
Stockholm, Sweden
RECRUITINGPain on load (change baseline to -12 months)
Pain (Numerical Rating Scale, 0-100 points, 100 is a worse outcome)
Time frame: 0-12 months
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
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
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
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
Objective function change baseline to -3, -6, -12 months
Range of motion (goniometer with 5 degrees interval)
Time frame: 0-12 months
Objective function change baseline to -3, -6, -12 months
grip strength (hydraulic hand dynamometer, kilograms)
Time frame: 0-12 months
Complications
2PD (Two point discrimination, 0-15mm, 15 indicating a worse outcome)
Time frame: 0-12 months
Complications
Mini Sollerman (0-12 points, 12 indicating a better outcome)
Time frame: 0-12 months
Complications
Infection (clinical evaluation, positive cultures, need for antibiotics)
Time frame: 0-12 months
Additional treatment
Need for further surgery/treatment
Time frame: 0-12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.