Osteoarthritis FingerNCT05980793
Denervation for Osteoarthritis in the PIP-joint Efficacy Study (DOPS)
A study testing PIP joint denervation and Patient education plus exercise in people with Osteoarthritis Finger and Surgery, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis Finger, Surgery
- What is being tested?
- PIP joint denervation and Patient education plus exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSweden
- Study dates
- 25 Sep 2023to 15 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Department of Hand Surgery, Södersjukhuset
Stockholm
Elin Swärd, MD, PhD
About this study
Official title: Denervation for Osteoarthritis in the PIP-joint Efficacy Study (DOPS), a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Osteoarthritis Finger, Surgery
- Being tested
- PIP joint denervation, Patient education plus exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIP joint denervationProcedure or surgery
Surgical denervation of the PIP joint
Patient education plus exerciseProcedure or surgery
An education plus exercise program
| Study group | Role | What they receive |
|---|---|---|
| Surgical treatment | Active comparator | PIP joint denervation is performed through a volar approach. Receives: Procedure: PIP joint denervation |
| Non-surgical treatment | Active comparator | An education and exercise program. Receives: Procedure: Patient education plus exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain on load (change baseline to -12 months)
Pain (Numerical Rating Scale, 0-100 points, 100 is a worse outcome)
Measured: 0-12 months
Secondary outcomes (10)
Pain at rest (change baseline to -3, -6, -12 months)
Pain (Numerical Rating Scale, 0-100 points, 100 is a worse outcome)
Measured: 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.
Measured: 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)
Measured: 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).
Measured: 0-12 months
Objective function change baseline to -3, -6, -12 months
Range of motion (goniometer with 5 degrees interval)
Measured: 0-12 months
Objective function change baseline to -3, -6, -12 months
grip strength (hydraulic hand dynamometer, kilograms)
Measured: 0-12 months
Complications
2PD (Two point discrimination, 0-15mm, 15 indicating a worse outcome)
Measured: 0-12 months
Complications
Mini Sollerman (0-12 points, 12 indicating a better outcome)
Measured: 0-12 months
Complications
Infection (clinical evaluation, positive cultures, need for antibiotics)
Measured: 0-12 months
Additional treatment
Need for further surgery/treatment
Measured: 0-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start25 Sep 2023
- Primary completion15 Jul 2028 (estimated)
- Study completion15 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis FingerStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A parallel group, two-arm, randomized, controlled trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Stockholm South General Hospital
- Responsible party
- Principal investigator, Elin Swärd, Karolinska Institutet
- Investigators
- Elin Sward, MD, PhD, Principal investigator, Department of Hand Surgery Sodersjukhuset and Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05980793
- Sponsor's protocol ID
- DOPS
- Status last verified
- Nov 2024
- First submitted
- 29 Jun 2023
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sward EM, Beckman J, Tabaroj F, Wilcke MK. Efficacy of denervation for osteoarthritis in the proximal interphalangeal joint (DOP): protocol of a randomized controlled trial. Trials. 2024 Aug 22;25(1):553. doi: 10.1186/s13063-024-08399-w.
PubMed 39169395
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Denervation for Osteoarthritis in the PIP-joint Efficacy Study (DOPS), a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05980793
- Acronym / sponsor ID
- DOPS
- Conditions
- Osteoarthritis Finger, Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Stockholm South General Hospital
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 15 Jul 2028 (estimated)
- Study completion
- 15 Jul 2029 (estimated)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A parallel group, two-arm, randomized, controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Surgical treatment | Active comparator | Procedure: PIP joint denervationPIP joint denervation is performed through a volar approach. |
| Non-surgical treatment | Active comparator | Procedure: Patient education plus exerciseAn education and exercise program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PIP joint denervationSurgical denervation of the PIP joint | Procedure or surgery | Surgical treatment |
| Patient education plus exerciseAn education plus exercise program | Procedure or surgery | Non-surgical treatment |
Primary outcome
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)
10 secondary outcomes
Pain at rest (change baseline to -3, -6, -12 months)
Time frame: 0-12 months
HQ8 (8-item patient questionnaire) change baseline to -3, -6, 12 months
Time frame: 0-12 months
PRWHE (Patient Rated Wrist/Hand Evaluation) change baseline to -3, 6, 12 months
Time frame: 0-12 months
EQ5D-5L change baseline to -3, -6, -12 months
Time frame: 0-12 months
Objective function change baseline to -3, -6, -12 months
Time frame: 0-12 months
Objective function change baseline to -3, -6, -12 months
Time frame: 0-12 months
Complications
Time frame: 0-12 months
Complications
Time frame: 0-12 months
Complications
Time frame: 0-12 months
Additional treatment
Time frame: 0-12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Derived from this study: PubMed 39169395Sward EM, Beckman J, Tabaroj F, Wilcke MK. Efficacy of denervation for osteoarthritis in the proximal interphalangeal joint (DOP): protocol of a randomized controlled trial. Trials. 2024 Aug 22;25(1):553. doi: 10.1186/s13063-024-08399-w.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elin Sward, MD, PhD principal investigator
Department of Hand Surgery Sodersjukhuset and Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PIP joint denervation and Patient education plus exercise in people with Osteoarthritis Finger and Surgery, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elin Sward, MD, PhD (+46812361000, elin.sward@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain on load (change baseline to -12 months) (time frame: 0-12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05980793, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.