An interventional study of Preoperative casting intervention in Dupuytren&Amp;#39;s Contracture, Dupuytren&Amp;#39;s Fasciectomy and Dupuytren&Amp;#39;s Disease, sponsored by Bournemouth University. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-17.
Sponsored by Bournemouth University · Not applicable, Interventional, and Treatment
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:
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.
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:
We are recruiting approximately 20 adult patients from Dorset County Hospital NHS Foundation Trust who:
Participants will be randomly assigned to one of two groups:
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:
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:
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.
79 studies on the registry are indexed under Contracture; 18 are open to participants now.
This study's planned enrollment of 20 is below the median of 33 across 62 interventional studies indexed under Contracture.
Browse Contracture studies →Bournemouth University is the lead sponsor of 52 studies on the registry; 10 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
An education session covering disease pathology, surgical objectives, postoperative expectations, pain, and recovery milestones only, with no added preoperative therapy.
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.
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.
Time frame: From enrolment 4 weeks preoperatively, till final follow-up at 12 weeks postoperatively
Active range of movement of the affected finger(s)
Active range of movement of the affected finger(s), recorded individually at the metacarpophalangeal (MCP), proximal interphalangeal (PIP), and distal interphalangeal (DIP) joints. Measurements are obtained using a standard manual goniometer, with the participant seated, forearm supported in neutral rotation, and wrist in a neutral position. * Flexion is defined as the angle at each joint when the participant actively attempts to flex the finger (i.e., make a fist), measured from the neutral (0°) position toward full flexion. * Extension is defined as the angle achieved at each joint when the participant actively attempts to fully straighten the finger, measured from the neutral position toward full extension or hyperextension. Each joint is measured and recorded separately in degrees for both maximal flexion and maximal extension. AROM is assessed at baseline, at each preoperative visit, and at 12 weeks postoperatively.
Time frame: From enrolment 4 weeks preoperatively, till final follow-up at 12 weeks postoperatively
Passive range of movement (PROM) of the affected finger(s)
Passive range of movement (PROM) of the affected finger(s), recorded individually at the metacarpophalangeal (MCP), proximal interphalangeal (PIP), and distal interphalangeal (DIP) joints. Measurements are obtained using a standard manual goniometer, with the participant seated, forearm supported in neutral rotation, and wrist in a neutral position. * Passive flexion is defined as the angle at each joint achieved when the examiner passively moves the finger into maximal flexion without patient effort, measured from the neutral (0°) position. * Passive extension is defined as the angle at each joint when the examiner passively moves the finger into full extension or hyperextension, again without patient effort. Each joint is measured and recorded separately in degrees for both maximal passive flexion and maximal passive extension. PROM is assessed at baseline, at each preoperative visit, and at 12 weeks postoperatively.
Time frame: From enrolment 4 weeks preoperatively, till final follow-up at 12 weeks postoperatively
Grip strength of the affected hand
Grip strength of the affected hand is measured using a Jamar hydraulic hand dynamometer. Strength is assessed in kilograms (kg) with the participant seated, shoulder adducted and neutrally rotated, elbow flexed at 90°, forearm in neutral position, and wrist positioned between 0-30° extension and 0-15° ulnar deviation. Participants are instructed to squeeze the dynamometer maximally for 3 seconds. Three trials are performed with a 30-second rest between attempts, and the mean value of the three trials is recorded. The second handle position on the Jamar dynamometer is used for consistency. Grip strength is measured at baseline, at each preoperative visit, and at 12 weeks postoperatively. Measurements at baseline and 12 weeks postoperatively are performed by therapists blinded to group allocation, using standardised equipment and procedures to ensure reliability and comparability across time points.
Time frame: From enrolment 4 weeks preoperatively, till final follow-up at 12 weeks postoperatively
Michigan Hand Questionnaire (MHQ)
Hand function is assessed using the Michigan Hand Questionnaire (MHQ), a validated, condition-specific, patient-reported outcome measure. The MHQ evaluates six domains: hand function, activities of daily living (ADLs), pain, work performance, aesthetics, and satisfaction with hand function. It consists of 37 items, each domain scored on a 0 to 100 scale. For all domains except pain, higher scores indicate better outcomes; in the pain domain, higher scores reflect greater pain. Participants complete the MHQ at baseline, at each preoperative visit, and at 12 weeks postoperatively. The questionnaire is administered by a therapist, who reads each question aloud and records the participant's responses directly onto the form, following the standardised MHQ scoring protocol.
Time frame: From enrolment 4 weeks preoperatively, till final follow-up at 12 weeks postoperatively
Patient-Specific Functional Scale (PSFS)
Hand function is also assessed using the Patient-Specific Functional Scale (PSFS). The PSFS is a validated, patient-reported outcome measure used to evaluate functional limitations specific to the individual's condition. Participants are asked to identify up to three activities that they are currently unable to perform or perform with difficulty due to their hand condition. Each activity is rated on a 0 to 10 numeric rating scale, where 0 represents "unable to perform the activity" and 10 represents "able to perform the activity without any difficulty." Scores are recorded for each activity, and an average score is calculated to reflect overall functional ability. The PSFS is administered at baseline, at each preoperative visit, and at 12 weeks postoperatively. This outcome measure captures patient-defined functional goals and changes over time, providing a highly individualised and responsive assessment of functional improvement
Time frame: From enrolment 4 weeks preoperatively, till final follow-up at 12 weeks postoperatively
Barriers and facilitators to adherence
Barriers and facilitators to attainment of the intervention, identified through semi-structured qualitative interviews with both participants and healthcare professionals involved in the trial. Interviews are conducted to explore individual and system-level factors that influence engagement with and delivery of the intervention, including adherence, acceptability, perceived benefit, and contextual constraints. Interviews are conducted at the end of the intervention period with a selection of participants using a topic guide developed from existing literature and trial objectives, and are audio-recorded, transcribed verbatim, and anonymised. Data are analysed thematically using framework analysis to identify recurring themes related to barriers and facilitators to intervention delivery and uptake.
Time frame: From enrolment 4 weeks preoperatively, till final follow-up at 12 weeks postoperatively
Sample size estimation
The sample size estimation for a future definitive trial will be informed by the distribution and completeness of outcome data, and by recruitment, consent, adherence, and retention rates observed during the trial. These estimates will be used to model various trial design scenarios, ensuring adequate power to detect clinically meaningful differences in a future randomised controlled trial.
Time frame: From enrolment 4 weeks preoperatively, till final follow-up at 12 weeks postoperatively
Plan to share: Yes — The findings of the trial will be made publicly available through publication or other dissemination tools without any unnecessary delay. Datasets will be made available by the corresponding author on reasonable request and in accordance with consent and ethical approval.
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Bournemouth University