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Spots Global Cancer Trial Database for Hand Therapy or Not Following Collagenase Treatment for Dupuytren's Contracture?

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Trial Identification

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

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

Study ID: NCT03580213

Study Description

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.

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Haukeland University Hospital, Bergen, , Norway

Contact Details

Name: Terese Aglen

Affiliation: Haukeland University Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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