NCT03580213

Hand Therapy or Not Following Collagenase Treatment for Dupuytren's Contracture?

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Haukeland University Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Dupuytren Disease of Palm and Finger, With Contracture

Interventions

Type	Name	Description
OTHER	Hand therapy MCPJ affected	Prevention of oedema, treatment of scar, splinting to maintain or improve extension, exercises, activity of daily living as exercise. Instructions, demonstration and advices.
OTHER	Hand therapy PIPJ affected	Prevention of oedema, treatment of scar, splinting to maintain or improve extension, exercises, activity of daily living as exercise. Instructions, demonstration and advices. Possible additional splint and exercises specifically for the PIPJ extension.

Timeline

• Start date: 2018-04-05
• Primary completion: 2023-05-03
• Completion: 2023-05-03
• First posted: 2018-07-09
• Last updated: 2023-09-22

Locations

1 site across 1 country: Norway