Clinical trial · Interventional
Comparing the Effectiveness of Two Post-fasciectomy Rehabilitation Protocols in Patients With Dupuytren's Disease
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dupuytren Contracture | Palmar Fibromatosis | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brief protocol | Other | — | UNRESOLVED |
| Intense protocol | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Brief protocol
- description
- 4 intervention sessions with the occupational therapist of 30 minutes duration.
- interventionNames
- Other: Brief protocol
- type
- ACTIVE_COMPARATOR
- label
- Intense Protocol
- description
- 6 intervention sessions with the occupational therapist of 60 minutes duration.
- interventionNames
- Other: Intense protocol
Primary outcomes (3)
- measure
- Change from first evaluation on the Michigan Hand Questionnaire at 2, 3 and 6 months
- timeFrame
- 0-3 days, 2 months, 3 months and 6 months after surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (15)
- BACKGROUNDBall 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
- BACKGROUNDBayat 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
- BACKGROUNDBell-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
- BACKGROUNDBudd 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
- BACKGROUNDDesai 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
- BACKGROUNDEfanov 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
- BACKGROUNDHuskisson 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
- BACKGROUNDHuisstede 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.