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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Bournemouth University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Progression criteria assessment
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Surgeon
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Preoperative casting intervention (Other)
Control group
An education session covering disease pathology, surgical objectives, postoperative expectations, pain, and recovery milestones only, with no added preoperative therapy.
Outcomes
Primary Outcomes
Progression criteria assessment
Time Frame: From enrolment 4 weeks preoperatively, till final follow-up at 12 weeks postoperatively
Primary Outcome Measure: Feasibility of progressing to a full randomised controlled trial (RCT) based on predefined progression criteria across eight domains. These include participant availability (≥37 listed for fasciectomy over 9 months), eligibility rate (≥54%), consent rate among eligible participants (≥80%), and willingness to undergo randomisation (≥80%). Additional feasibility indicators include the ability to maintain blinding of assessors and surgeons throughout the study, high intervention acceptability determined via qualitative evaluation, adherence to preoperative splinting (\>80%), and retention at 12-week follow-up (\>80%). Safety is assessed by tracking adverse events, with progression supported if ≤20% of participants experience an adverse reaction. Thresholds for "Go," "Amend," or "Stop" decisions are defined for each domain.
Secondary Outcomes
- Active range of movement of the affected finger(s)(From enrolment 4 weeks preoperatively, till final follow-up at 12 weeks postoperatively)
- Passive range of movement (PROM) of the affected finger(s)(From enrolment 4 weeks preoperatively, till final follow-up at 12 weeks postoperatively)
- Grip strength of the affected hand(From enrolment 4 weeks preoperatively, till final follow-up at 12 weeks postoperatively)
- Michigan Hand Questionnaire (MHQ)(From enrolment 4 weeks preoperatively, till final follow-up at 12 weeks postoperatively)
- Patient-Specific Functional Scale (PSFS)(From enrolment 4 weeks preoperatively, till final follow-up at 12 weeks postoperatively)
- Barriers and facilitators to adherence(From enrolment 4 weeks preoperatively, till final follow-up at 12 weeks postoperatively)
- Sample size estimation(From enrolment 4 weeks preoperatively, till final follow-up at 12 weeks postoperatively)