Osteoarthritis WristNCT06098586
Wrist Denervation Vs Exercise in Wrist Osteoarthritis
A study testing Self-managed exercise therapy program and Partial wrist denervation in people with Osteoarthritis Wrist, run by Karolinska Institutet at 2 sites in Sweden.
Trial summary
A randomized controlled trial comparing partial wrist denervation to a self-managed exercise therapy program in 140 patients with wrist osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis Wrist
- What is being tested?
- Self-managed exercise therapy program and Partial wrist denervation
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesSweden
- Study dates
- 15 Nov 2023to 15 Nov 2027
- 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 wrist pain (≥6 months) due to Scapholunate advanced collapse (SLAC) / Scaphoid non-union advanced collapse (SNAC) grade 1-3 osteoarthritis.
- Radiological signs of osteoarthritis on posteroanterior and lateral radiograph.
Who cannot join
- Previous PIN or AIN neurectomy.
- Rheumatoid arthritis or other chronic inflammatory arthritis.
- Symptomatic osteoarthritis in the distal radio-ulnar (DRU), Scapho-trapezio-trapezoid (STT) or thumb carpometacarpal (CMC) joints.
- Ongoing infection.
- Inability to co-operate with the follow-up protocol.
- Systemic or intra-articular glucocorticoids or intraarticular PRP or Hyaluronic acid injections in the affected joint within 3 months prior to enrollment.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites, 2 recruiting
- Recruiting
Department of hand surgery, Malmo university hospital
Malmö, 20502
Elisabeth Brogren, MD, PhD, +46040336052, elisabeth.brogren@med.lu.se
Sara Larsson, PhD, +46040336052, sara.larsson.5408@med.lu.se
- Recruiting
Department of hand handsurgery, Södersjukhuset
Stockholm, 11883
Elin M Swärd, MD, PhD, +4681236000, elin.sward@regionstockholm.se
Maria K Wilcke, MD. PhD, +4681236000, Maria.Wilcke@regionstockholm.se
About this study
Official title: Partial Wrist Denervation Versus Self-managed Exercise Therapy in Patients with Wrist Osteoarthritis: a Randomized Controlled Multicenter Trial
A randomized controlled trial comparing partial wrist denervation to a self-managed exercise therapy program in 140 patients with wrist osteoarthritis.
Read the detailed description
Backgroud:
High quality evidence regarding the effectiveness of non-operative and operative treatments in wrist osteoarthritis are lacking.
Aim:
To analyze:
- Does partial wrist denervation and self-managed exercise therapy improve patient-reported outcomes, pain, grip strength and range of motion (ROM) in wrist OA?
- Is any of the two treatment concepts partial wrist denervation and self-managed exercise therapy more efficient than the other in terms of patient-reported outcomes, pain relief, grip strength and range of motion?
Method:
A multicenter parallel group, two-arm, randomized, controlled, assessor blinded, trial of 140 patients. The study is conducted at the departments of hand surgery at Södersjukhuset Stockholm and Malmö University hospital.
Group1:
Self-managed exercise therapy program containing:
- Patient education:
- Exercise therapy program:
The exercise therapy program is designed by Sara Larsson (physiotherapist at the Department of hand surgery in Malmö, Sweden), influenced by previous studies on wrist stability and proprioception. Focus is on functional re-learning and strengthening of the musculoskeletal system with the aim to create a stable wrist that can be used in a pain-free manner in activities of daily living. The program consists of neuromuscular exercises that focus on coordination, wrist stability and strength.
Group 2:
Surgery will be performed under local anesthesia (+ blood-less field or wide-awake local anesthesia no torniquet (WALANT) according to the surgeon's preference) through a single dorsal incision. AIN and PIN neurectomy will be performed as described by Berger (Berger, 1998).
Primary outcome:
Patient Rated Wrist Evaluation (PRWE) score (0-100) (MacDermid et al., 1998) 12 months after intervention.
- Conditions
- Osteoarthritis Wrist
- Being tested
- Self-managed exercise therapy program, Partial wrist denervation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-managed exercise therapy programBehavioural
Exercise program focusing on functional re-learning and strengthening of the musculoskeletal system with the aim to create a stable wrist that can be used in a pain-free manner in activities of daily living.
Partial wrist denervationProcedure or surgery
AIN and PIN neurectomy through a dorsal approach as described by Berger (Berger, 1998).
| Study group | Role | What they receive |
|---|---|---|
| Self-managed exercise therapy program | Active comparator | Exercise program focusing on functional re-learning and strengthening of the musculoskeletal system with the aim to create a stable wrist that can be used in a pain-free manner in activities of daily living. Receives: Behavioral: Self-managed exercise therapy program |
| Partial wrist denervation | Active comparator | AIN and PIN neurectomy through a dorsal approach as described by Berger (Berger, 1998). Receives: Procedure: Partial wrist denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
PRWE
Patient Rated Wrist Evaluation (PRWE) score (0-100 (high score worse outcome)) (MacDermid et al., 1998)
Measured: 6 months
Secondary outcomes (37)
PRWE
Patient Rated Wrist Evaluation (PRWE) score (0-100 (high score worse outcome)) (MacDermid et al., 1998)
Measured: 3 months
PRWE
Patient Rated Wrist Evaluation (PRWE) score (0-100 (high score worse outcome)) (MacDermid et al., 1998)
Measured: 12 months
PRWE
Patient Rated Wrist Evaluation (PRWE) score (0-100 (high score worse outcome)) (MacDermid et al., 1998)
Measured: 5 years
Pain NRS
Pain at rest and on load measured by a Numerical Rating Scale (NRS, 0-100 (higher score worse outcome) (Salaffi et al 2004)
Measured: 3 months
Pain NRS
Pain at rest and on load measured by a Numerical Rating Scale (NRS, 0-100 (higher score worse outcome) (Salaffi et al 2004)
Measured: 6 months
Pain NRS
Pain at rest and on load measured by a Numerical Rating Scale (NRS, 0-100 (higher score worse outcome) (Salaffi et al 2004)
Measured: 12 months
Pain NRS
Pain at rest and on load measured by a Numerical Rating Scale (NRS, 0-100 (higher score worse outcome) (Salaffi et al 2004)
Measured: 5 years
EQ5D
EQ-5D-5L (0-1 (higher score better outcome)) (Brooks, 1996)
Measured: 3 months
EQ5D
EQ-5D-5L (0-1 (higher score better outcome)) (Brooks, 1996)
Measured: 6 months
EQ5D
EQ-5D-5L (0-1 (higher score better outcome)) (Brooks, 1996)
Measured: 12 months
EQ5D
EQ-5D-5L (0-1 (higher score better outcome)) (Brooks, 1996)
Measured: 5 years
GROC
Global rating of change (GROC, -5-+5, higher score better outcome)
Measured: 3 months
GROC
Global rating of change (GROC, -5-+5, higher score better outcome)
Measured: 6 months
GROC
Global rating of change (GROC, -5-+5, higher score better outcome)
Measured: 12 months
GROC
Global rating of change (GROC, -5-+5, higher score better outcome)
Measured: 5 years
Pain catastrophizing
PCS (Pain catastrophizing scale, 0-52, higher score worse outcome) (Sullivan et al, 1995)
Measured: 3 months
Pain catastrophizing
PCS (Pain catastrophizing scale, 0-52, higher score worse outcome) (Sullivan et al, 1995)
Measured: 6 months
Pain catastrophizing
PCS (Pain catastrophizing scale, 0-52, higher score worse outcome) (Sullivan et al, 1995)
Measured: 12 months
Pain catastrophizing
PCS (Pain catastrophizing scale, 0-52, higher score worse outcome) (Sullivan et al, 1995)
Measured: 5 years
ROM
Range of motion (ROM) of the wrist.
Measured: 3 months
ROM
Range of motion (ROM) of the wrist.
Measured: 6 months
ROM
Range of motion (ROM) of the wrist.
Measured: 12 months
ROM
Range of motion (ROM) of the wrist.
Measured: 5 years
Grip
Grip strength (Jamar).
Measured: 3 months
Grip
Grip strength (Jamar).
Measured: 6 months
Grip
Grip strength (Jamar).
Measured: 12 months
Grip
Grip strength (Jamar).
Measured: 5 years
Complications
Complications related to treatment
Measured: 3 months
Complications
Complications related to treatment
Measured: 6 months
Complications
Complications related to treatment
Measured: 12 months
Complications
Complications related to treatment
Measured: 5 years
Radiology
Radiological grade of osteoarthritis 5 years after inclusion compared to baseline.
Measured: 5 years
Cost
Differences in direct costs associated with treatment and indirect costs.
Measured: 12 months
sick leave
length of sick leave
Measured: 12 months
work
ability to return to previous work
Measured: 12 months
Survival
Success of the intervention, i.e no additional surgery during the study period due to lack of treatment effect or recurrence of symptoms.
Measured: 12 months
Survival
Success of the intervention, i.e no additional surgery during the study period due to lack of treatment effect or recurrence of symptoms.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start15 Nov 2023
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Nov 2027 (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 WristStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elin Swärd, Karolinska Institutet
- Investigators
- Elin Swärd, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098586
- Sponsor's protocol ID
- 2023-04885-01
- Other IDs
- 2023
- Status last verified
- Nov 2024
- First submitted
- 18 Oct 2023
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Larsson SL, Tandrup T, Brogren E, Wilcke MK, Sward EM. Partial wrist denervation versus patient education and self-managed exercise therapy in patients with wrist osteoarthritis: study protocol for a randomized controlled trial. Trials. 2025 Oct 30;26(1):453. doi: 10.1186/s13063-025-09241-7.
PubMed 41168861
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partial Wrist Denervation Versus Self-managed Exercise Therapy in Patients with Wrist Osteoarthritis: a Randomized Controlled Multicenter Trial
- ClinicalTrials.gov ID
- NCT06098586
- Acronym / sponsor ID
- 2023-04885-01
- Conditions
- Osteoarthritis Wrist
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Nov 2027 (estimated)
- First posted
- 24 Oct 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.
A randomized controlled trial comparing partial wrist denervation to a self-managed exercise therapy program in 140 patients with wrist osteoarthritis.
Detailed description
Backgroud:
High quality evidence regarding the effectiveness of non-operative and operative treatments in wrist osteoarthritis are lacking.
Aim:
To analyze:
- Does partial wrist denervation and self-managed exercise therapy improve patient-reported outcomes, pain, grip strength and range of motion (ROM) in wrist OA?
- Is any of the two treatment concepts partial wrist denervation and self-managed exercise therapy more efficient than the other in terms of patient-reported outcomes, pain relief, grip strength and range of motion?
Method:
A multicenter parallel group, two-arm, randomized, controlled, assessor blinded, trial of 140 patients. The study is conducted at the departments of hand surgery at Södersjukhuset Stockholm and Malmö University hospital.
Group1:
Self-managed exercise therapy program containing:
- Patient education:
- Exercise therapy program:
The exercise therapy program is designed by Sara Larsson (physiotherapist at the Department of hand surgery in Malmö, Sweden), influenced by previous studies on wrist stability and proprioception. Focus is on functional re-learning and strengthening of the musculoskeletal system with the aim to create a stable wrist that can be used in a pain-free manner in activities of daily living. The program consists of neuromuscular exercises that focus on coordination, wrist stability and strength.
Group 2:
Surgery will be performed under local anesthesia (+ blood-less field or wide-awake local anesthesia no torniquet (WALANT) according to the surgeon's preference) through a single dorsal incision. AIN and PIN neurectomy will be performed as described by Berger (Berger, 1998).
Primary outcome:
Patient Rated Wrist Evaluation (PRWE) score (0-100) (MacDermid et al., 1998) 12 months after intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-managed exercise therapy program | Active comparator | Behavioral: Self-managed exercise therapy programExercise program focusing on functional re-learning and strengthening of the musculoskeletal system with the aim to create a stable wrist that can be used in a pain-free manner in activities of daily living. |
| Partial wrist denervation | Active comparator | Procedure: Partial wrist denervationAIN and PIN neurectomy through a dorsal approach as described by Berger (Berger, 1998). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years.
- Chronic wrist pain (≥6 months) due to Scapholunate advanced collapse (SLAC) / Scaphoid non-union advanced collapse (SNAC) grade 1-3 osteoarthritis.
- Radiological signs of osteoarthritis on posteroanterior and lateral radiograph.
Key exclusion criteria (6 listed)
- Previous PIN or AIN neurectomy.
- Rheumatoid arthritis or other chronic inflammatory arthritis.
- Symptomatic osteoarthritis in the distal radio-ulnar (DRU), Scapho-trapezio-trapezoid (STT) or thumb carpometacarpal (CMC) joints.
- Ongoing infection.
- Inability to co-operate with the follow-up protocol.
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 |
|---|---|---|
| Self-managed exercise therapy programExercise program focusing on functional re-learning and strengthening of the musculoskeletal system with the aim to create a stable wrist that can be used in a pain-free manner in activities of daily living. | Behavioural | Self-managed exercise therapy program |
| Partial wrist denervationAIN and PIN neurectomy through a dorsal approach as described by Berger (Berger, 1998). | Procedure or surgery | Partial wrist denervation |
Primary outcome
PRWE
Time frame: 6 months
Patient Rated Wrist Evaluation (PRWE) score (0-100 (high score worse outcome)) (MacDermid et al., 1998)
37 secondary outcomes
PRWE
Time frame: 3 months
PRWE
Time frame: 12 months
PRWE
Time frame: 5 years
Pain NRS
Time frame: 3 months
Pain NRS
Time frame: 6 months
Pain NRS
Time frame: 12 months
Pain NRS
Time frame: 5 years
EQ5D
Time frame: 3 months
EQ5D
Time frame: 6 months
EQ5D
Time frame: 12 months
EQ5D
Time frame: 5 years
GROC
Time frame: 3 months
GROC
Time frame: 6 months
GROC
Time frame: 12 months
GROC
Time frame: 5 years
Pain catastrophizing
Time frame: 3 months
Pain catastrophizing
Time frame: 6 months
Pain catastrophizing
Time frame: 12 months
Pain catastrophizing
Time frame: 5 years
ROM
Time frame: 3 months
ROM
Time frame: 6 months
ROM
Time frame: 12 months
ROM
Time frame: 5 years
Grip
Time frame: 3 months
Grip
Time frame: 6 months
Grip
Time frame: 12 months
Grip
Time frame: 5 years
Complications
Time frame: 3 months
Complications
Time frame: 6 months
Complications
Time frame: 12 months
Complications
Time frame: 5 years
Radiology
Time frame: 5 years
Cost
Time frame: 12 months
sick leave
Time frame: 12 months
work
Time frame: 12 months
Survival
Time frame: 12 months
Survival
Time frame: 5 years
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 21 Feb 2025.
- Derived from this study: PubMed 41168861Larsson SL, Tandrup T, Brogren E, Wilcke MK, Sward EM. Partial wrist denervation versus patient education and self-managed exercise therapy in patients with wrist osteoarthritis: study protocol for a randomized controlled trial. Trials. 2025 Oct 30;26(1):453. doi: 10.1186/s13063-025-09241-7.
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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 Swärd, MD, PhD principal investigator
Karolinska Institutet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-managed exercise therapy program and Partial wrist denervation in people with Osteoarthritis Wrist, run by Karolinska Institutet at 2 sites 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 3 inclusion and 6 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 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Swärd, MD, PhD (+4612360000, elin.sward@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PRWE (time frame: 6 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 NCT06098586, 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 21 Feb 2025.