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

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ClinicalTrials.gov Identifier: NCT03982719
Recruitment Status : Enrolling by invitation
First Posted : June 11, 2019
Last Update Posted : June 13, 2019
Sponsor:
Collaborators:
CHU de Quebec-Universite Laval
Centre interdisciplinaire de recherche en réadaptation et intégration sociale
Information provided by (Responsible Party):
Véronique Flamand, Laval University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Dupuytren Contracture Other: Brief protocol Other: Intense protocol Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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.




Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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).


Secondary Outcome Measures :
  1. 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°)

  2. 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.)

  3. Grip strength [ Time Frame: 2 months, 3 months and 6 months after surgery ]
    JAMAR dynamometer (data scope 0-80 kg, accuracy of 2 kg)

  4. 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)

  5. Tactile sensibility [ Time Frame: 2 months, 3 months and 6 months after surgery ]
    Semmes-Weinstein monofilaments



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03982719


Locations
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Canada
CHU de Québec
Québec, Canada, G1R 2J6
Sponsors and Collaborators
Véronique Flamand
CHU de Quebec-Universite Laval
Centre interdisciplinaire de recherche en réadaptation et intégration sociale
Investigators
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Principal Investigator: Veronique Flamand, PhD Center for Interdisciplinary Research in Rehabilitation and Social Integration

Publications:

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Responsible Party: Véronique Flamand, Assistant Professor and Researcher, Laval University
ClinicalTrials.gov Identifier: NCT03982719     History of Changes
Other Study ID Numbers: Dupuytren2019-4462
First Posted: June 11, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Véronique Flamand, Laval University:
Dupuytren's disease
rehabilitation
fasciectomy
hand therapy

Additional relevant MeSH terms:
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Contracture
Dupuytren Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Fibroma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Connective Tissue Diseases