Comparing the Effectiveness of Two Post-fasciectomy Rehabilitation Protocols in Patients With Dupuytren's Disease

June 11, 2019 updated by: Véronique Flamand

Randomized Controlled Trial Comparing the Effectiveness of Two Post-fasciectomy Rehabilitation Protocols Differing in Intensity and Implementation of Modalities in Patients With Dupuytren's Disease

Dupuytren's disease can cause physical impairments that lead to reduced functional performance in personal care, work-related and leisure activities. The prevalence of Dupuytren's disease increases with age. A meta-analysis completed in 2014 by Lanting and al. estimated the its prevalence in western countries at 12% among people aged 55 years and over and at 29% among individuals aged 75 and over. The fasciectomy is the most current surgical procedure to reduce the flexion contracture occurring in this disease. Studies confirm the relevance of post-operative rehabilitation after fasciectomy. This rehabilitation is usually conducted by hand therapists who are mostly occupational therapists. However, the required duration and frequency of interventions and exercises for the post-op rehabilitation are not clearly described in the literature. In fact, the guidelines that are currently available recommend a total duration between 16 and 75 hours, which is highly variable. Also, the need to include supervised exercises by the occupational therapist is not specified. The main goal of this study is to compare two post-fasciectomy rehabilitation protocols to determine the influence of protocols intensity on motor and functional outcomes in people with Dupuytren's disease. The hypothesis is that the protocol involving a higher intensity will lead to better motor and functional improvements. The secondary goal of this study is to explore the link between the total time that the person has done the recommended exercises (combination of supervised exercises and the home program) and motor/functional recovery. The hypothesis is that the relationship between the amount of time and the motor/functional improvements will not be linear, but will either be logarithmic toward a plateau of recovery.

A randomized controlled trial will be realized. 40 participants will be randomly assigned to one of the two rehabilitation protocols. Each participant will be evaluated at four times (initial evaluation, final evaluation and 2 follow-up evaluations). Data on motor and functional recovery will be collected.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Dupuytren's disease can cause physical impairments that lead to reduced functional performance in personal care, work-related and leisure activities. The prevalence of Dupuytren's disease increases with age. A meta-analysis completed in 2014 by Lanting and al. estimated the its prevalence in western countries at 12% among people aged 55 years and over and at 29% among individuals aged 75 and over. The fasciectomy is the most current surgical procedure to reduce the flexion contracture occurring in this disease. Studies confirm the relevance of post-operative rehabilitation after fasciectomy. This rehabilitation is usually conducted by hand therapists who are mostly occupational therapists. However, the required duration and frequency of interventions and exercises for the post-op rehabilitation are not clearly described in the literature. In fact, the guidelines that are currently available recommend a total duration between 16 and 75 hours, which is highly variable. Also, the need to include supervised exercises by the occupational therapist is not specified. The main goal of this study is to compare two post-fasciectomy rehabilitation protocols to determine the influence of protocols intensity on motor and functional outcomes in people with Dupuytren's disease. The hypothesis is that the protocol involving a higher intensity will lead to better motor and functional improvements. The secondary goal of this study is to explore the link between the total time that the person has done the recommended exercises (combination of supervised exercises and the home program) and motor/functional recovery. The hypothesis is that the relationship between the amount of time and the motor/functional improvements will not be linear, but will either be logarithmic towards a plateau of recovery.

A randomized controlled trial will be realized. 40 participants will be randomly assigned to one of the two rehabilitation protocols. Each participant will be evaluated at four times (initial evaluation, final evaluation and 2 follow-up evaluations). The independent variable of this study is the intensity of the rehabilitation protocol (BRIEF or INTENSE). The primary dependent variable is the functional abilities to perform activities of daily living. The secondary dependent variables are the following : digits range of motion, pain, grip and pinch strengths, as well as tactile sensibility.

The BRIEF PROTOCOL consists of 4 intervention sessions with an occupational therapist specialized in hand therapy that will occur at 0-3 days, 2 weeks, 4 weeks and 8 weeks post-fasciectomy. The occupational therapist will give recommendations about the management of swelling, wound care and functional recovery. An home exercises program will be given to the participant. Finally, an extension splint that must be worn at night until the third month after surgery will be made at the first session. The INTENSE PROTOCOL consists of 6 intervention sessions with an occupational therapist specialized in hand therapy that will occur at 0-3 days, 2 weeks, 3 weeks, 4 weeks, 6 weeks and 8 weeks after surgery. The occupational therapist will give recommendations about the management of swelling, wound care and functional recovery. An home exercises program will be given to the participant. An extension splint that must be worn at night until the third month after surgery will be made at the first session. Also, exercises will be performed by the patient under the supervision of the occupational therapist (supervised exercises) in each session except the first one at 0-3 days after surgery.

Statistical analyses will take into account the moderate size of our sample (n=40) and the independence of the two groups. Descriptive statistics and Shapiro-Wilk test will be used to evaluate if variables follow the normal distribution. If the normal distribution is confirmed, repeated measure ANOVA will be used to compare the 2 groups. If not, Mann-Whitney test will be used (non-parametric test). Pearson correlation coefficient (parametric) or Spearman correlation coefficient (non-parametric) will be used to analyze the relationships between variables (secondary aim of the study).

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Québec, Canada, G1R 2J6
        • CHU de Quebec

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

53 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • To present Dupuytren's contracture to one or two digits of the same hand and at an important stage of Dupuytren's Disease before the surgery (PIP contracture of 45 degrees or more)
  • Having had a fasciectomy to treat Dupuytren's Disease with per-op PIP contracture of 30 degrees or less.

Exclusion Criteria:

  • Recurrence of Dupuytren's Disease
  • To have or have had a complex regional pain syndrome
  • To present a health condition that could affect cognitive functions (dementia, neuro-cognitive disorders)
  • To have a diagnosis of diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brief protocol
4 intervention sessions with the occupational therapist of 30 minutes duration.
Other: Brief protocol
This protocol consists of 4 intervention sessions with an occupational therapist specialized in hand therapy that will occur at 0-3 days, 2 weeks, 4 weeks and 8 weeks post-fasciectomy. The occupational therapist will give recommendations about the management of swelling, wound care and functional recovery. An home exercises program will be given to the participant. The occupational therapist will make an extension splint that should be worn at night for the 3 months following surgery.
Active Comparator: Intense Protocol
6 intervention sessions with the occupational therapist of 60 minutes duration.
Other: Intense protocol
This protocol consists of 6 intervention sessions with an occupational therapist specialized in hand therapy that will occur at 0-3 days, 2 weeks, 3 weeks, 4 weeks, 6 weeks and 8 weeks after surgery. The occupational therapist will give recommendations about the management of swelling, wound care and functional recovery. An home exercises program will be given to the participant. The occupational therapist will make an extension splint that should be worn at night for the 3 months following surgery. Also, exercises will be performed by the patient under the supervision of the occupational therapist (supervised exercises) in each session except the first one at 0-3 days after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from first evaluation on the Michigan Hand Questionnaire at 2, 3 and 6 months
Time Frame: 0-3 days, 2 months, 3 months and 6 months after surgery
Patient-reported questionnaire that evaluates function and quality of life in patients with hand disorders. There are 37 items divided into 6 subscales (1)overall hand function, (2)activities of daily living, (3)pain, (4)work performance, (5)aesthetics and (6)patient's satisfaction with hand function). (Total score between 0-100, rating scale from 1 to 5)
0-3 days, 2 months, 3 months and 6 months after surgery
Change from first evaluation on the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) outcome measure at 2, 3 and 6 months
Time Frame: 0-3 days, 2 months, 3 months and 6 months after surgery
Patient-reported questionnaire that evaluates 11 items on symptoms and functional impairments related to musculoskeletal disorders of the upper limb. (Total score between 0-100, rating scale from 1 to 5)
0-3 days, 2 months, 3 months and 6 months after surgery
Change from first evaluation on the Sollerman Test at 2, 3 and 6 months
Time Frame: 2 months and 6 months after surgery
A standardized hand function assessment based on seven of the eight most common hand grips that consists of 20 activities of daily living. (Total score between 0-80, rating scale 0 to 4).
2 months and 6 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Range of motion assessed by Rolyan digital goniometer
Time Frame: 0-3 days, 2 months, 3 months and 6 months after surgery
Range of motion of the affected digits assessed by Rolyan digital goniometer (data scope -30° to 120°, accuracy of 2°)
0-3 days, 2 months, 3 months and 6 months after surgery
Pain measured using the Visual Analogue Scale
Time Frame: 0-3 days, 2 months, 3 months and 6 months after surgery
Responders specify their level of pain by indicating a position along a continuous line between two end-points. One end (corresponding to score 0) represents the absence of pain, and the other end (corresponding to score 100) represents the worst pain that the person can imagine. (Thus the minimum score is 0, and the maximum score is 100. There are no sub-scales. 0 represents the absence of pain, and higher values represent more pain.)
0-3 days, 2 months, 3 months and 6 months after surgery
Grip strength
Time Frame: 2 months, 3 months and 6 months after surgery
JAMAR dynamometer (data scope 0-80 kg, accuracy of 2 kg)
2 months, 3 months and 6 months after surgery
Pinch strength
Time Frame: 2 months, 3 months and 6 months after surgery
B&L pinch gauge (data scope 0-30 pounds, accuracy of 1 pound)
2 months, 3 months and 6 months after surgery
Tactile sensibility
Time Frame: 2 months, 3 months and 6 months after surgery
Semmes-Weinstein monofilaments
2 months, 3 months and 6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Véronique Flamand

Collaborators

CHU de Quebec-Universite Laval
Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale

Investigators

  • Principal Investigator: Veronique Flamand, PhD, Center for Interdisciplinary Research in Rehabilitation and Social Integration

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2019

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

June 7, 2019

First Submitted That Met QC Criteria

June 10, 2019

First Posted (Actual)

June 11, 2019

Study Record Updates

Last Update Posted (Actual)

June 13, 2019

Last Update Submitted That Met QC Criteria

June 11, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dupuytren2019-4462

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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