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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Progression criteria assessment
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Surgeon
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Progression criteria assessment
时间窗: 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.
次要结局
- 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)