Preoperative Serial Casting, Education, and Therapy for Dupuytren's Contracture
NCT ID: NCT07024576
Last Updated: 2025-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
20 participants
INTERVENTIONAL
2025-09-30
2026-09-30
Brief Summary
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The study is taking place at Dorset County Hospital and will involve people who are already scheduled for surgery and have a permanent bend of 30 degrees or more in the middle joint of one or more fingers.
The therapy will be given before surgery to see if it helps people get a better result afterwards.
We want to find out:
* Who would be suitable to take part in a future, larger study
* Which results are most important to measure (like finger movement or grip strength)
* How many people complete the full therapy and follow-up We'll also speak to patients and healthcare professionals to understand how acceptable and practical this therapy is.
The goal is to see whether it's possible and worthwhile to run a larger study in the future, to find out if pre-surgery therapy can become a helpful part of treatment for people undergoing Dupuytren's Fasciectomy.
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Detailed Description
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This feasibility study investigates whether a short course of preoperative therapy, delivered before surgery, can help improve recovery and outcomes after Dupuytren's Fasciectomy. The intervention includes:
* Heat application
* Stretching and massage
* Serial casting - a method of gently lengthening tight tissue by applying and adjusting a soft cast weekly prior to surgery The treatment is designed to gently lengthen tight tissues and increase joint range of movement in the affected fingers prior to surgery, with the goal of improving movement and function after surgery.
We are recruiting approximately 20 adult patients from Dorset County Hospital NHS Foundation Trust who:
* Are scheduled for Dupuytren's Fasciectomy
* Have a PIP joint contracture of 30 degrees or more
Participants will be randomly assigned to one of two groups:
* Intervention group: Will receive the four-week preoperative therapy programme plus an education session covering disease pathology, surgical objectives, postoperative expectations, pain, and recovery milestones.
* Control group: Will receive the same education programme only, with no added preoperative therapy.
After surgery, all participants will follow standard postoperative therapy and attend follow-up appointments up to 12 weeks post-op, where we will collect outcome measures including:
* Finger range of motion
* Hand function (using the Michigan Hand Outcomes Questionnaire - MHQ)
* Grip strength
* Patient satisfaction
* Completion and retention rates throughout the study To understand how practical and acceptable this approach is in real-world clinical settings, we will also conduct interviews with patients and healthcare professionals to explore their experiences and suggestions for improvement.
As a feasibility study, the goal is not to test effectiveness, but to assess whether a larger, definitive trial is achievable. Specifically, we aim to:
* Determine who is suitable and willing to take part
* Identify the most relevant outcome measures
* Evaluate participation and follow-up rates
* Understand acceptability from both patients and clinicians
* Estimate the resources and planning needed for a full-scale trial If this study shows that the intervention is feasible and well-received, we aim to proceed with a multi-centre randomised controlled trial to evaluate the effectiveness of preoperative therapy as part of standard care for Dupuytren's fasciectomy.
This research is a collaboration between Dorset County Hospital NHS Foundation Trust and Bournemouth University, with active involvement and guidance from a Patient and Public Involvement steering group made up of individuals with lived experience of Dupuytren's disease and the healthcare professionals involved in their care.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Intervention group
A serial casting intervention protocol involving the application of heat, stretching, and massage before casting. This is repeated weekly for four weeks, with the cast removed and reapplied each time to promote gradual elongation of restricted tissue. Additionally, they will receive an education session covering disease pathology, surgical objectives, postoperative expectations, pain, and recovery milestones.
Preoperative casting intervention
A serial casting intervention protocol involving the application of heat, stretching, and massage before casting. This is repeated weekly for four weeks, with the cast removed and reapplied each time to promote gradual elongation of restricted tissue.
Control group
An education session covering disease pathology, surgical objectives, postoperative expectations, pain, and recovery milestones only, with no added preoperative therapy.
No interventions assigned to this group
Interventions
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Preoperative casting intervention
A serial casting intervention protocol involving the application of heat, stretching, and massage before casting. This is repeated weekly for four weeks, with the cast removed and reapplied each time to promote gradual elongation of restricted tissue.
Eligibility Criteria
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Inclusion Criteria
* One or more fingers with a Dupuytren's flexion contracture greater than 30° at the PIP joint.
* Awaiting fasciectomy surgery for Dupuytren's contracture.
* Willing and able to provide informed consent for participation in the study.
Exclusion Criteria
* A history of previous treatment for Dupuytren's contracture (e.g., surgery, collagenase injection, or needle fasciectomy) to the study reference digit.
* A history of any other pre-existing hand disorder causing significant movement restriction, pain, or affecting hand function (e.g., post-traumatic stiffness, arthritis, infection).
* Non-English speaking participants due to the need for completing multiple questionnaires that have not been validated in multiple languages.
* Inability to attend follow-up appointments within the required timeframes.
18 Years
ALL
No
Sponsors
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Dorset County Hospital NHS Foundation Trust
OTHER_GOV
Bournemouth University
OTHER
Responsible Party
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Principal Investigators
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Timothy Crook
Role: PRINCIPAL_INVESTIGATOR
Dorchester County Hospital
Locations
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Dorchester County Hospital NHS Foundation Trust
Dorchester, Dorset, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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Mellor K, Albury C, Dutton SJ, Eldridge S, Hopewell S. Recommendations for progression criteria during external randomised pilot trial design, conduct, analysis and reporting. Pilot Feasibility Stud. 2023 Apr 15;9(1):59. doi: 10.1186/s40814-023-01291-5.
Other Identifiers
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11151
Identifier Type: -
Identifier Source: org_study_id
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