Department of Hand Surgery, Södersjukhuset
Stockholm, Sweden
Location status: Recruiting
Location contact
Elin Swärd, MD, PhD
CONTACT
NCT Number: NCT05980793
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Stockholm, Sweden
Location status: Recruiting
Elin Swärd, MD, PhD
CONTACT
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Surgical denervation of the PIP joint
An education plus exercise program
Time frame: 0-12 months
Pain (Numerical Rating Scale, 0-100 points, 100 is a worse outcome)
Time frame: 0-12 months
Pain (Numerical Rating Scale, 0-100 points, 100 is a worse outcome)
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.
Time frame: 0-12 months
A questionnaire that measures hand/wrist function (0-100 points, 100 is a worse outcome)
Time frame: 0-12 months
A questionnaire that measures quality of life (0-1 point, 0 is a worse outcome).
Time frame: 0-12 months
Range of motion (goniometer with 5 degrees interval)
Time frame: 0-12 months
grip strength (hydraulic hand dynamometer, kilograms)
Time frame: 0-12 months
2PD (Two point discrimination, 0-15mm, 15 indicating a worse outcome)
Time frame: 0-12 months
Mini Sollerman (0-12 points, 12 indicating a better outcome)
Time frame: 0-12 months
Infection (clinical evaluation, positive cultures, need for antibiotics)
Time frame: 0-12 months
Need for further surgery/treatment
Contact information is provided by the study sponsor or research team.
Karolinska Institutet
Other
Denervation for Osteoarthritis in the PIP-joint Efficacy Study (DOPS), a Randomized Controlled Trial
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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