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

Dupuytren Disease of Palm and Finger, With Contracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03580213
• Other study ID #: 2017/613
• Status: Completed
• Phase: N/A
• Start date: April 5, 2018
• Est. completion date: May 3, 2023

Study information

• Verified date: March 2022
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: May 3, 2023
• Est. primary completion date: May 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients treated with collagenase injection and extension procedure for Dupuytren's contracture

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Contracture
• Dupuytren Contracture
• Dupuytren Disease of Palm and Finger, With Contracture

Intervention

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.
• 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.

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in sensitivity to cold from baseline to 6 weeks, from baseline to 4 months and to 1 year.	yes/no	Change from Baseline to 6 weeks from baseline to 4 months and to 1 year
Other	Change in sick-leave status from baseline to 6 weeks, from baseline to 4 months and to 1 year.	yes/no	Change from Baseline to 6 weeks from baseline to 4 months and to 1 year
Other	Patient liability	Did the patient do as the protocol for therapy instructed? yes/no	Measured at 1 year from baseline
Primary	Canadian Occupational Performance Measure (COPM) change from baseline to 6 weeks, from 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.	change from baseline to 6 weeks, baseline to 4 months and to 1 year.
Secondary	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.	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.	Change from Baseline to 6 weeks, from baseline to 4 months and to 1 year
Secondary	Change on Range of motion (ROM) 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 from Baseline to 6 weeks, from baseline to 4 months and to 1 year
Secondary	Change on Visual Analogue Scale of pain (VAS) from baseline to 6 weeks, from 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 from Baseline to 6 weeksfrom baseline to 4 months and to 1 year
Secondary	Change in grip force from baseline to 6 weeks, from baseline to 4 months and to 1 year.	Jamar dynamometer	Change from Baseline to 6 weeks from baseline to 4 months and to 1 year