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: 1. Does partial wrist denervation and self-managed exercise therapy improve patient-reported outcomes, pain, grip strength and range of motion (ROM) in wrist OA? 2. 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
140
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.
AIN and PIN neurectomy through a dorsal approach as described by Berger (Berger, 1998).
Department of hand surgery, Malmo university hospital
Malmo, Sweden
RECRUITINGDepartment of hand handsurgery, Södersjukhuset
Stockholm, Sweden
RECRUITINGPRWE
Patient Rated Wrist Evaluation (PRWE) score (0-100 (high score worse outcome)) (MacDermid et al., 1998)
Time frame: 6 months
PRWE
Patient Rated Wrist Evaluation (PRWE) score (0-100 (high score worse outcome)) (MacDermid et al., 1998)
Time frame: 3 months
PRWE
Patient Rated Wrist Evaluation (PRWE) score (0-100 (high score worse outcome)) (MacDermid et al., 1998)
Time frame: 12 months
PRWE
Patient Rated Wrist Evaluation (PRWE) score (0-100 (high score worse outcome)) (MacDermid et al., 1998)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
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Time frame: 5 years
EQ5D
EQ-5D-5L (0-1 (higher score better outcome)) (Brooks, 1996)
Time frame: 3 months
EQ5D
EQ-5D-5L (0-1 (higher score better outcome)) (Brooks, 1996)
Time frame: 6 months
EQ5D
EQ-5D-5L (0-1 (higher score better outcome)) (Brooks, 1996)
Time frame: 12 months
EQ5D
EQ-5D-5L (0-1 (higher score better outcome)) (Brooks, 1996)
Time frame: 5 years
GROC
Global rating of change (GROC, -5-+5, higher score better outcome)
Time frame: 3 months
GROC
Global rating of change (GROC, -5-+5, higher score better outcome)
Time frame: 6 months
GROC
Global rating of change (GROC, -5-+5, higher score better outcome)
Time frame: 12 months
GROC
Global rating of change (GROC, -5-+5, higher score better outcome)
Time frame: 5 years
Pain catastrophizing
PCS (Pain catastrophizing scale, 0-52, higher score worse outcome) (Sullivan et al, 1995)
Time frame: 3 months
Pain catastrophizing
PCS (Pain catastrophizing scale, 0-52, higher score worse outcome) (Sullivan et al, 1995)
Time frame: 6 months
Pain catastrophizing
PCS (Pain catastrophizing scale, 0-52, higher score worse outcome) (Sullivan et al, 1995)
Time frame: 12 months
Pain catastrophizing
PCS (Pain catastrophizing scale, 0-52, higher score worse outcome) (Sullivan et al, 1995)
Time frame: 5 years
ROM
Range of motion (ROM) of the wrist.
Time frame: 3 months
ROM
Range of motion (ROM) of the wrist.
Time frame: 6 months
ROM
Range of motion (ROM) of the wrist.
Time frame: 12 months
ROM
Range of motion (ROM) of the wrist.
Time frame: 5 years
Grip
Grip strength (Jamar).
Time frame: 3 months
Grip
Grip strength (Jamar).
Time frame: 6 months
Grip
Grip strength (Jamar).
Time frame: 12 months
Grip
Grip strength (Jamar).
Time frame: 5 years
Complications
Complications related to treatment
Time frame: 3 months
Complications
Complications related to treatment
Time frame: 6 months
Complications
Complications related to treatment
Time frame: 12 months
Complications
Complications related to treatment
Time frame: 5 years
Radiology
Radiological grade of osteoarthritis 5 years after inclusion compared to baseline.
Time frame: 5 years
Cost
Differences in direct costs associated with treatment and indirect costs.
Time frame: 12 months
sick leave
length of sick leave
Time frame: 12 months
work
ability to return to previous work
Time frame: 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.
Time frame: 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.
Time frame: 5 years