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

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.

Study Overview

• Status: Completed
• Conditions: Dupuytren Disease of Palm and Finger, With Contracture
• Intervention / Treatment: Other: Hand therapy MCPJ affected; Other: Hand therapy PIPJ affected

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Terese Aglen; Phone Number: +47 55975460; Email: terese.aglen@helse-bergen.no

Study Locations

• Norway
  • Bergen, Norway, 5021
    • Haukeland University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Experimental: 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.	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.
No Intervention: Control group MCPJ affected; 40 participants With Dupuytren's contracture with only the Metacarpophalangeal joints affected. No treatment after the collagenase injection and extension treatment.
No Intervention: Control group PIPJ affected; 40 participants With Dupuytren's contracture with only the Metacarpophalangeal joints affected. No treatment after the collagenase injection and extension treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Patient liability	Did the patient do as the protocol for therapy instructed? yes/no	Measured at 1 year from baseline

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Investigators: Principal Investigator: Terese Aglen, Haukeland University Hospital

Publications and helpful links

General Publications

• Aglen T, Matre KH, Lind C, Selles RW, Assmus J, Taule T. Hand therapy or not following collagenase treatment for Dupuytren's contracture? Protocol for a randomised controlled trial. BMC Musculoskelet Disord. 2019 Aug 28;20(1):387. doi: 10.1186/s12891-019-2712-z.

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2018
• Primary Completion (Actual): May 3, 2023
• Study Completion (Actual): May 3, 2023

Study Registration Dates

• First Submitted: April 10, 2018
• First Submitted That Met QC Criteria: July 6, 2018
• First Posted (Actual): July 9, 2018

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Physical Therapy; Occupational Therapy; ROM; Scar; Oedema; ADL; COPM; Orthosis; Hand Therapy; Splint; URAM; Hand exercise
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Muscular Diseases; Neoplasms, Connective Tissue; Neoplasms, Fibrous Tissue; Fibroma; Contracture; Dupuytren Contracture
• Other Study ID Numbers: 2017/613

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No