Dupuytren Disease
Conditions
Keywords
Dupuytren disease, Osteopathy, Physiotherapy
Brief summary
This randomized, double-blind clinical trial evaluates whether adding targeted osteopathy to physiotherapy improves recovery after open surgery for Dupuytren disease. Patients who have undergone their first open fasciectomy for Dupuytren disease will be randomly assigned to one of two groups. Both groups will receive physiotherapy. One group will additionally receive a targeted osteopathy session, while the other group will receive a sham osteopathy session. The main objective is to evaluate recovery of extension of the metacarpophalangeal joint of the operated finger. Secondary outcomes include hand function, extension of the proximal and distal interphalangeal joints, grip strength, scar vascularization, quality of life, scar adherence, and postoperative pain. The study will include 50 adult patients. Participants will be followed for 12 weeks, with assessments at 1, 4, 8, and 12 weeks after the start of treatment.
Detailed description
Dupuytren disease is a chronic fibroproliferative condition of the hand characterized by progressive fibrosis of the palmar aponeurosis, which can lead to nodules, fibrous cords, digital retractions, and contractures. These deformities may impair hand function and daily activities and may affect quality of life. For advanced stages of the disease, open fasciectomy is a surgical treatment. Although surgery generally allows recovery of finger extension, postoperative recovery may be prolonged and may be associated with persistent inflammation, scar adhesions, altered tissue gliding, and temporary reductions in mobility and strength. The purpose of this pilot randomized controlled trial is to evaluate the potential benefit of adding osteopathy to conventional postoperative physiotherapy following open fasciectomy for Dupuytren disease. According to the study protocol, the benefits of osteopathy in this specific postoperative context have not previously been evaluated in a prospective randomized controlled trial. After eligibility has been confirmed and informed consent has been obtained, participants will be randomly assigned to one of two groups. Both groups will receive physiotherapy as part of postoperative care. The experimental group will receive a targeted osteopathy session, while the control group will receive a sham osteopathy session. Physiotherapy and osteopathy sessions are planned to take place on the same day when possible. A gentle night extension splint will be applied on postoperative day 8 according to the usual protocol. The primary outcome is recovery of extension of the metacarpophalangeal joint of the operated finger, assessed by goniometry at 1, 4, 8, and 12 weeks after the start of treatment. Secondary outcomes include hand function assessed using the Unité Rhumatologique des Affections de la Main (URAM) score; extension of the proximal and distal interphalangeal joints assessed by goniometry; grip strength assessed using a hand dynamometer; scar vascularization assessed using an infrared camera (FLIR ONE Pro); hand-related quality of life assessed using the Brief Michigan Hand Outcomes Questionnaire (Brief MHQ); scar adherence assessed using an adhesiometer; and postoperative pain assessed using the Visual Analog Scale (VAS). These outcomes will be assessed at 1, 4, 8, and 12 weeks after the start of treatment. The planned sample size is 50 participants. The planned inclusion period is 15 months, with a 3-month follow-up for each participant and a total planned study duration of 18 months.
Interventions
Physiotherapy
Sham osteopathy
Sponsors
Study design
Intervention model description
Randomized, double-blind, two-group parallel study comparing targeted osteopathy with sham osteopathy, both combined with physiotherapy.
Eligibility
Inclusion criteria
* Age ≥ 18 years * Ability to provide informed consent * Adults operated for Dupuytren disease, stages 2-3, excluding PIP deformity \>90° * First open fasciectomy * No participation in another clinical trial * Affiliation with social security * Acceptance of questionnaires * Acceptance of 12-week follow-up
Exclusion criteria
* Minor * Previous intervention on the same hand * Associated hand conditions: symptomatic finger osteoarthritis, other major hand pathologies, significant neuropathies * History of poor wound healing Diabetes * Central or peripheral neurological diseases affecting the hand * Protected adult under curatorship or guardianship * Refusal to participate * Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MCP joint extension | 1, 4, 8, and 12 weeks after treatment start | Goniometric measurement of metacarpophalangeal (MCP) joint extension |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| URAM score | 1, 4, 8, and 12 weeks after treatment start | Assessment of hand function using the Unité Rhumatologique des Affections de la Main (URAM) score. |
| PIP and DIP joint extension | 1, 4, 8, and 12 weeks after treatment start | Goniometric measurement of proximal and distal interphalangeal joint extension. |
| Grip strength | 1, 4, 8, and 12 weeks after treatment start | Measurement of grip strength using a hand dynamometer. |
| Scar vascularization | 1, 4, 8, and 12 weeks after treatment start | Assessment of scar vascularization using a FLIR ONE Pro infrared camera. |
| Brief Michigan Hand Questionnaire (Brief MHQ) score | 1, 4, 8, and 12 weeks after treatment start | Assessment of quality of life using the Brief Michigan Hand Questionnaire (Brief MHQ). |
| Scar adherence | 1, 4, 8, and 12 weeks after treatment start | Assessment of scar adherence using an adhesiometer. |
| Postoperative pain | 1, 4, 8, and 12 weeks after treatment start | Assessment of pain using a visual analog scale (VAS). |
Countries
France