Preoperative Serial Casting, Education, and Therapy for Dupuytren's Contracture

NCT07024576 | Not Yet Recruiting

• 1 other identifier: 11151
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Dupuytren&Amp;#39;s Contracture; Dupuytren&Amp;#39;s Fasciectomy; Dupuytren&Amp;#39;s Disease

Keywords

Dupuytren's; Fasciectomy; Preoperative therapy

Outcome Measures

Primary Outcomes (1)

• Progression criteria assessment

  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.

  From enrolment 4 weeks preoperatively, till final follow-up at 12 weeks postoperatively

Secondary Outcomes (7)

• 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

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Other: Preoperative casting intervention

Control group

NO INTERVENTION

An education session covering disease pathology, surgical objectives, postoperative expectations, pain, and recovery milestones only, with no added preoperative therapy.

Interventions

Preoperative casting intervention OTHER

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bournemouth University: lead
• Dorset County Hospital NHS Foundation Trust: collaborator

Study Sites (1)

Dorchester County Hospital NHS Foundation Trust

Dorchester, Dorset, DT1 2JY, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 37061720 BACKGROUND

Study Officials

• Timothy Crook

  Dorchester County Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tahra Babiker-Moore

CONTACT

+447974709699; tbabikermoore@bournemouth.ac.uk

Carol Clark

CONTACT

cclark@bournemouth.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Surgeon
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-arm randomised feasibility study

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 17, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)