Hand Therapy or Not Following Collagenase Treatment for Dupuytren's Contracture?
- Conditions
- Dupuytren Disease of Palm and Finger, With Contracture
- Interventions
- Other: Hand therapy PIPJ affectedOther: Hand therapy MCPJ affected
- Registration Number
- NCT03580213
- Lead Sponsor
- Haukeland University Hospital
- Brief Summary
This study evaluates if hand therapy have an impact on the patients' preformance of and satisfaction with everyday activities or not following collagenase injection treatment for Dupuytren's contracture. Differences on this between patients with contracted proximal interphalangeal joint(s) and patients with affected metacarpophalangeal joint(s) only, will also be investigated. Two equal sized groups will either receive hand therapy or no treatment following the injection and extension procedure.
- Detailed Description
Today it varies if patients with collagenase treated Dupuytren's contracture (DC) are referred to hand therapy or not. No studies are found looking at the effect of therapy following collagenase treatment compared to no therapy.
The main purpose of the study is to find if hand therapy improves patients' performance of and satisfaction with everyday activities or not, one year after collagenase treatment for DC. Differences on this between patients with contracted proximal interphalangeal joint(s) (PIPJ) and patients with affected metacarpophalangeal joint(s) (MCPJ) only, will also be investigated.
A Norwegian randomised controlled trial will be conducted with two parallel intervention groups in a pre-test - post-test design. Hand therapy includes oedema control, scar management, night-time splinting, movement exercises and use of everyday activities as therapy. Additional individualised therapy will be provided if needed. Test times are right before, straight after, six weeks, four months and one year after collagenase treatment. Sample size needed is 160 participants. Appropriate methods of statistical analysis will be used.
Discussion Research on DC is challenging as the clinical picture is heterogeneous, no cure exists and no agreement on who should receive collagenase treatment. Hand therapy in the study will be individualised and not equal for every patient.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
- patients treated with collagenase injection and extension procedure for Dupuytren's contracture
- earlier injury or treatment for Dupuytren's contracture in the same finger
- patients not capable of following a therapy program
- before randomisation: infection or an allergic reaction to the drug or Complex regional pain syndrome arising
- earlier participation in the same study makes the participant not eligible to be included once more when treated in the other hand.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hand therapy PIPJ affected Hand therapy PIPJ affected 40 participants With Dupuytren's contracture with the proximal interphalangeal joint involved, receiving hand therapy after collagenase injection and extension treatment. Hand therapy: edema control, wound and scar treatment, splinting, exercises for hand, exercise through activities of daily living. Possible additional splint and exercises specifically for the PIPJ extension. Hand therapy MCPJ affected Hand therapy MCPJ affected 40 participants With Dupuytren's contracture with only the Metacarpophalangeal joints affected, receiving hand therapy after collagenase injection and extension treatment. Hand therapy: edema control, wound and scar treatment, splinting, exercises for hand, exercise through activities of daily living.
- Primary Outcome Measures
Name Time Method Canadian Occupational Performance Measure (COPM) change from baseline to 6 weeks, from baseline to 4 months and to 1 year. change from baseline to 6 weeks, baseline to 4 months and to 1 year. An individualized, client-centred outcome measure. COPM is an evidence-based outcome measure designed to capture a patient's self-perception of performance in everyday living, over time.
- Secondary Outcome Measures
Name Time Method Change in grip force from baseline to 6 weeks, from baseline to 4 months and to 1 year. Change from Baseline to 6 weeks from baseline to 4 months and to 1 year Jamar dynamometer
Change on Visual Analogue Scale of pain (VAS) from baseline to 6 weeks, from baseline to 4 months and to 1 year. Change from Baseline to 6 weeksfrom baseline to 4 months and to 1 year Visual analogue scale of pain. The patient scores from 0-10cm how much pain they have had the last week. No pain is scored 0 and worse pain is 10.
Change on Range of motion (ROM) from baseline to 6 weeks, from baseline to 4 months and to 1 year. Change from Baseline to 6 weeks, from baseline to 4 months and to 1 year Each affected joint will be measured for movement in extension and flexion with a goniometer.
Change on Unité Rhumatoloique des Affections de la Main (URAM) scale results from baseline to 6 weeks, from baseline to 4 months and to 1 year. Change from Baseline to 6 weeks, from baseline to 4 months and to 1 year URAM, the Norwegian translation will be used. The scale evaluates the patients ability to perform 9 specific daily activities, which the patient are asked to score. The values are 6 ranges of difficulty: from no difficulties with doing the activity (score 0) to impossible to do (score 5). The possible total score ranges from 0 to 45, where 45 is the worse case.
Trial Locations
- Locations (1)
Haukeland University Hospital
🇳🇴Bergen, Norway