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Completed

NCT Number: NCT03580213

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.

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Key information

Conditions

Dupuytren Disease of Palm and Finger, With Contracture Cicatrix Connective Tissue Diseases Contracture Dupuytren Contracture Edema Fibroma Fibrosis Muscular Diseases Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibrous Tissue Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haukeland University Hospital

Bergen, 5021, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hand therapy MCPJ affected

Other

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

Other

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.

Primary outcomes

  1. Canadian Occupational Performance Measure (COPM) change from baseline to 6 weeks, from baseline to 4 months and to 1 year.

    Time frame: 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 outcomes

  1. 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.

    Time frame: 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.

  2. Change on Range of motion (ROM) from baseline to 6 weeks, from baseline to 4 months and to 1 year.

    Time frame: 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.

  3. Change on Visual Analogue Scale of pain (VAS) from baseline to 6 weeks, from baseline to 4 months and to 1 year.

    Time frame: 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.

  4. Change in grip force from baseline to 6 weeks, from baseline to 4 months and to 1 year.

    Time frame: Change from Baseline to 6 weeks from baseline to 4 months and to 1 year

    Jamar dynamometer

Other outcomes

  1. Change in sensitivity to cold from baseline to 6 weeks, from baseline to 4 months and to 1 year.

    Time frame: Change from Baseline to 6 weeks from baseline to 4 months and to 1 year

    yes/no

  2. Change in sick-leave status from baseline to 6 weeks, from baseline to 4 months and to 1 year.

    Time frame: Change from Baseline to 6 weeks from baseline to 4 months and to 1 year

    yes/no

  3. Patient liability

    Time frame: Measured at 1 year from baseline

    Did the patient do as the protocol for therapy instructed? yes/no

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jul 9, 2018
Registry last updated
Sep 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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