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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBournemouth University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Preoperative casting intervention

    Other 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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

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.

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bournemouth University

Lead sponsor

Dorset County Hospital NHS Foundation Trust

Collaborator

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