Clinical trial NCT07024576: Preoperative Serial Casting, Education, and Therapy for Dupuytren's Contracture
Official title: Preoperative Serial Casting, Stretching, and Massage Therapy Package for Dupuytren's Patients With Severe Proximal Interphalangeal Joint Contracture: A Feasibility Study Protocol for a Randomised Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dupuytren&Amp;#39;s Contracture
Dupuytren&Amp;#39;s Fasciectomy
Dupuytren&Amp;#39;s Disease
Keywords: Dupuytren&amp;#39;s
Fasciectomy
Preoperative therapy
Lead sponsor: Bournemouth University
Sponsor class: OTHER
Collaborators: name: Dorset County Hospital NHS Foundation Trust
First posted: 2025-06-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm randomised feasibility study
Primary purpose: TREATMENT

Brief summary: We are running a small study to test whether a special type of therapy - including casting, stretching, and massage - might help improve recovery after Dupuytren's Fasciectomy.

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.

Detailed description: Dupuytren's disease is a common and progressively disabling condition affecting the connective tissue of the palm of the hand. It causes fibrosis of the palmar fascia, which can lead to one or more fingers becoming incapable of full extension, adopting a fixed flexion contracture. This loss of extension can significantly impair hand function and limit daily activities. While surgery (typically fasciectomy) remains the most effective treatment for Dupuytren's contracture, outcomes are often less favourable when the deformity involves the proximal interphalangeal joint, particularly in severe cases where the contracture exceeds 30 degrees.

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.

Eligibility criteria: Inclusion Criteria:

* Male or female participants aged 18 years or older.
* 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:

* Individuals awaiting needle fasciotomy, dermofasciectomy, or segmental fasciectomy.
* 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.

Primary outcomes:
measure: Progression criteria assessment
timeFrame: From enrolment 4 weeks preoperatively, till final follow-up at 12 weeks postoperatively
Secondary outcomes:
measure: Active range of movement of the affected finger(s)
timeFrame: From enrolment 4 weeks preoperatively, till final follow-up at 12 weeks postoperatively
measure: Passive range of movement (PROM) of the affected finger(s)
timeFrame: From enrolment 4 weeks preoperatively, till final follow-up at 12 weeks postoperatively
measure: Grip strength of the affected hand
timeFrame: From enrolment 4 weeks preoperatively, till final follow-up at 12 weeks postoperatively
measure: Michigan Hand Questionnaire (MHQ)
timeFrame: From enrolment 4 weeks preoperatively, till final follow-up at 12 weeks postoperatively
measure: Patient-Specific Functional Scale (PSFS)
timeFrame: From enrolment 4 weeks preoperatively, till final follow-up at 12 weeks postoperatively
measure: Barriers and facilitators to adherence
timeFrame: From enrolment 4 weeks preoperatively, till final follow-up at 12 weeks postoperatively
measure: Sample size estimation
timeFrame: From enrolment 4 weeks preoperatively, till final follow-up at 12 weeks postoperatively
Other outcomes:
Locations:
city: Dorchester
country: United Kingdom
facility: Dorchester County Hospital NHS Foundation Trust
state: Dorset
Study officials:
affiliation: Dorchester County Hospital
name: Timothy Crook
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.