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A randomized controlled trial comparing partial wrist denervation to a self-managed exercise therapy program in 140 patients with wrist osteoarthritis.
Backgroud:
High quality evidence regarding the effectiveness of non-operative and operative treatments in wrist osteoarthritis are lacking.
Aim:
To analyze:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Partial wrist denervation | Active Comparator | AIN and PIN neurectomy through a dorsal approach as described by Berger (Berger, 1998). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-managed exercise therapy program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| PRWE | Patient Rated Wrist Evaluation (PRWE) score (0-100 (high score worse outcome)) (MacDermid et al., 1998) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| PRWE | Patient Rated Wrist Evaluation (PRWE) score (0-100 (high score worse outcome)) (MacDermid et al., 1998) | 3 months |
| PRWE | Patient Rated Wrist Evaluation (PRWE) score (0-100 (high score worse outcome)) (MacDermid et al., 1998) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elin Swärd, MD, PhD | Contact | +4612360000 | elin.sward@regionstockholm.se |
| Name | Affiliation | Role |
|---|---|---|
| Elin Swärd, MD, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of hand surgery, Malmo university hospital | Recruiting | Malmö | 20502 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41168861 | Derived | 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. |
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Data assessors and analysts will be masked for treatment allocation (covered wrist / anonymous data sheet).
| Partial wrist denervation | Procedure | AIN and PIN neurectomy through a dorsal approach as described by Berger (Berger, 1998). |
|
| 12 months |
| PRWE | Patient Rated Wrist Evaluation (PRWE) score (0-100 (high score worse outcome)) (MacDermid et al., 1998) | 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) | 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) | 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) | 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) | 5 years |
| EQ5D | EQ-5D-5L (0-1 (higher score better outcome)) (Brooks, 1996) | 3 months |
| EQ5D | EQ-5D-5L (0-1 (higher score better outcome)) (Brooks, 1996) | 6 months |
| EQ5D | EQ-5D-5L (0-1 (higher score better outcome)) (Brooks, 1996) | 12 months |
| EQ5D | EQ-5D-5L (0-1 (higher score better outcome)) (Brooks, 1996) | 5 years |
| GROC | Global rating of change (GROC, -5-+5, higher score better outcome) | 3 months |
| GROC | Global rating of change (GROC, -5-+5, higher score better outcome) | 6 months |
| GROC | Global rating of change (GROC, -5-+5, higher score better outcome) | 12 months |
| GROC | Global rating of change (GROC, -5-+5, higher score better outcome) | 5 years |
| Pain catastrophizing | PCS (Pain catastrophizing scale, 0-52, higher score worse outcome) (Sullivan et al, 1995) | 3 months |
| Pain catastrophizing | PCS (Pain catastrophizing scale, 0-52, higher score worse outcome) (Sullivan et al, 1995) | 6 months |
| Pain catastrophizing | PCS (Pain catastrophizing scale, 0-52, higher score worse outcome) (Sullivan et al, 1995) | 12 months |
| Pain catastrophizing | PCS (Pain catastrophizing scale, 0-52, higher score worse outcome) (Sullivan et al, 1995) | 5 years |
| ROM | Range of motion (ROM) of the wrist. | 3 months |
| ROM | Range of motion (ROM) of the wrist. | 6 months |
| ROM | Range of motion (ROM) of the wrist. | 12 months |
| ROM | Range of motion (ROM) of the wrist. | 5 years |
| Grip | Grip strength (Jamar). | 3 months |
| Grip | Grip strength (Jamar). | 6 months |
| Grip | Grip strength (Jamar). | 12 months |
| Grip | Grip strength (Jamar). | 5 years |
| Complications | Complications related to treatment | 3 months |
| Complications | Complications related to treatment | 6 months |
| Complications | Complications related to treatment | 12 months |
| Complications | Complications related to treatment | 5 years |
| Radiology | Radiological grade of osteoarthritis 5 years after inclusion compared to baseline. | 5 years |
| Cost | Differences in direct costs associated with treatment and indirect costs. | 12 months |
| sick leave | length of sick leave | 12 months |
| work | ability to return to previous work | 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. | 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. | 5 years |
| Department of hand handsurgery, Södersjukhuset | Recruiting | Stockholm | 11883 | Sweden |
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