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

NCT03982719 | Unknown DMC

• 1 other identifier: Dupuytren2019-4462
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Dupuytren Contracture

Keywords

Dupuytren's disease; rehabilitation; fasciectomy; hand therapy

Outcome Measures

Primary Outcomes (3)

• Change from first evaluation on the Michigan Hand Questionnaire at 2, 3 and 6 months

  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

  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

  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 Outcomes (5)

• Range of motion assessed by Rolyan digital goniometer

  0-3 days, 2 months, 3 months and 6 months after surgery

• Pain measured using the Visual Analogue Scale

  0-3 days, 2 months, 3 months and 6 months after surgery

• Grip strength

  2 months, 3 months and 6 months after surgery

• Pinch strength

  2 months, 3 months and 6 months after surgery

• Tactile sensibility

  2 months, 3 months and 6 months after surgery

Study Arms (2)

Brief protocol

EXPERIMENTAL

4 intervention sessions with the occupational therapist of 30 minutes duration.

Other: Brief protocol

Intense Protocol

ACTIVE COMPARATOR

6 intervention sessions with the occupational therapist of 60 minutes duration.

Other: Intense protocol

Interventions

Brief protocol OTHER

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.

Brief protocol

Intense protocol OTHER

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.

Intense Protocol

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Véronique Flamand: lead
• CHU de Quebec-Universite Laval: collaborator
• Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale: collaborator

Study Sites (1)

CHU de Québec

Québec, G1R 2J6, Canada

Location

Related Publications (15)

• Ball C, Pratt AL, Nanchahal J. Optimal functional outcome measures for assessing treatment for Dupuytren's disease: a systematic review and recommendations for future practice. BMC Musculoskelet Disord. 2013 Apr 10;14:131. doi: 10.1186/1471-2474-14-131.

  PMID: 23575442 BACKGROUND

• Bayat A, McGrouther DA. Management of Dupuytren's disease--clear advice for an elusive condition. Ann R Coll Surg Engl. 2006 Jan;88(1):3-8. doi: 10.1308/003588406X83104.

  PMID: 16460628 BACKGROUND

• Bell-Krotoski JA, Fess EE, Figarola JH, Hiltz D. Threshold detection and Semmes-Weinstein monofilaments. J Hand Ther. 1995 Apr-Jun;8(2):155-62. doi: 10.1016/s0894-1130(12)80314-0.

  PMID: 7550627 BACKGROUND

• Budd HR, Larson D, Chojnowski A, Shepstone L. The QuickDASH score: a patient-reported outcome measure for Dupuytren's surgery. J Hand Ther. 2011 Jan-Mar;24(1):15-20; quiz 21. doi: 10.1016/j.jht.2010.08.006. Epub 2010 Nov 24.

  PMID: 21106346 BACKGROUND

• Desai SS, Hentz VR. The treatment of Dupuytren disease. J Hand Surg Am. 2011 May;36(5):936-42. doi: 10.1016/j.jhsa.2011.03.002.

  PMID: 21527148 BACKGROUND

• Efanov JI, Shine JJ, Darwich R, Besner Morin C, Arsenault J, Harris PG, Danino AM, Izadpanah A. French translation and cross-cultural adaptation of the Michigan Hand Outcomes Questionnaire and the Brief Michigan Hand Outcomes Questionnaire. Hand Surg Rehabil. 2018 Apr;37(2):86-90. doi: 10.1016/j.hansur.2017.12.003. Epub 2018 Jan 17.

  PMID: 29373241 BACKGROUND

• Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.

  PMID: 4139420 BACKGROUND

• Huisstede BMA, Hoogvliet P, Coert JH, Friden J; European HANDGUIDE Group. Dupuytren disease: European hand surgeons, hand therapists, and physical medicine and rehabilitation physicians agree on a multidisciplinary treatment guideline: results from the HANDGUIDE study. Plast Reconstr Surg. 2013 Dec;132(6):964e-976e. doi: 10.1097/01.prs.0000434410.40217.23.

  PMID: 24281643 BACKGROUND

• Lanting R, Broekstra DC, Werker PMN, van den Heuvel ER. A systematic review and meta-analysis on the prevalence of Dupuytren disease in the general population of Western countries. Plast Reconstr Surg. 2014 Mar;133(3):593-603. doi: 10.1097/01.prs.0000438455.37604.0f.

  PMID: 24263394 BACKGROUND

• Lewis E, Fors L, Tharion WJ. Interrater and intrarater reliability of finger goniometric measurements. Am J Occup Ther. 2010 Jul-Aug;64(4):555-61. doi: 10.5014/ajot.2010.09028.

  PMID: 20825126 BACKGROUND

• Mathiowetz V, Weber K, Volland G, Kashman N. Reliability and validity of grip and pinch strength evaluations. J Hand Surg Am. 1984 Mar;9(2):222-6. doi: 10.1016/s0363-5023(84)80146-x.

  PMID: 6715829 BACKGROUND

• Melchior H, Vatine JJ, Weiss PL. Is there a relationship between light touch-pressure sensation and functional hand ability? Disabil Rehabil. 2007 Apr 15;29(7):567-75. doi: 10.1080/09638280600902547.

  PMID: 17453977 BACKGROUND

• Sollerman C, Ejeskar A. Sollerman hand function test. A standardised method and its use in tetraplegic patients. Scand J Plast Reconstr Surg Hand Surg. 1995 Jun;29(2):167-76. doi: 10.3109/02844319509034334.

  PMID: 7569815 BACKGROUND

• Sweet S, Blackmore S. Surgical and therapy update on the management of Dupuytren's disease. J Hand Ther. 2014 Apr-Jun;27(2):77-83; quiz 84. doi: 10.1016/j.jht.2013.10.006. Epub 2013 Nov 5.

  PMID: 24388681 BACKGROUND

• Wilburn J, McKenna SP, Perry-Hinsley D, Bayat A. The impact of Dupuytren disease on patient activity and quality of life. J Hand Surg Am. 2013 Jun;38(6):1209-14. doi: 10.1016/j.jhsa.2013.03.036.

  PMID: 23707018 BACKGROUND

MeSH Terms

Conditions

Dupuytren Contracture

Condition Hierarchy (Ancestors)

Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Contracture; Muscular Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Veronique Flamand, PhD

  Center for Interdisciplinary Research in Rehabilitation and Social Integration

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor and Researcher

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: June 11, 2019
• Study Start: June 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: June 13, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)