Denervation for Osteoarthritis in the PIP-joint Efficacy Study (DOPS), a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Pain on load (change baseline to -12 months)
研究概览
简要总结
The goal of this clinical trial is to compare the effects of a surgical and a non-surgical treatment method in patients with osteoarthritis in the proximal interphalangeal (PIP) joint. The main questions it aims to answer are:
- Are the treatments effective?
- Is the surgical treatment more effective than the non-surgical treatment? Participants will receive surgical treatment (PIP joint denervation) or non surgical treatment (patient education plus exercise).
Researchers will compare the non-surgical and surgical groups to see if pain, patient-reported function, quality of life, movement and grip strength differs between the groups.
详细描述
This is a parallel group, two-arm, randomized, controlled trial comparing the effects of surgical denevation to patient education plus exercise in patients with symptomatic PIP joint osteoarthritis.
The research questions are:
- Does any of the treatments denervation of the PIP-joint and patient education plus exercise decrease pain, improve patient-reported outcomes, grip strength and range of motion (ROM) in PIP-joint osteoarthritis?
- Does denervation of the PIP-joint decrease pain, and improve patient-reported outcomes grip strength and ROM more effectively than patient education plus exercise for PIP-joint osteoarthritis?
Participants will be randomly assigned (1:1) to receive surgical denervation of the PIP-joint or education plus exercise. A block randomization scheme with a fixed block size of 10 will be used. Patients will be stratified according to gender. Sealed opaque envelopes will be used and data analysts will be masked for treatment allocation.
Assesments will be made at inclusion, and after 3, 6 and 12 months. The studys primary enpoint is 12 months after intervention.
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
Data analysts will be masked for treatment allocation
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
- •Age ≥ 18 years.
- •Chronic symptomatic osteoarthritis in the PIP-joint.
- •Radiological signs of osteoarthritis on posteroanterior and lateral radiographs assessed by the Kellgren-Lawrence classification (grade II-IV) (Kellgren & Lawrence, 1957).
- •Clinical signs of PIP-joint arthritis.
排除标准
- •Inflammatory arthritis.
- •Ongoing infection in the hand.
- •Inability to co-operate with the follow-up protocol.
- •Intra-articular glucocorticoid, PRP or Hyaluronic acid injections in the affected joint less than 3 months prior to enrollment.
结局指标
主要结局
Pain on load (change baseline to -12 months)
时间窗: 0-12 months
Pain (Numerical Rating Scale, 0-100 points, 100 is a worse outcome)
次要结局
- EQ5D-5L change baseline to -3, -6, -12 months(0-12 months)
- HQ8 (8-item patient questionnaire) change baseline to -3, -6, 12 months(0-12 months)
- PRWHE (Patient Rated Wrist/Hand Evaluation) change baseline to -3, 6, 12 months(0-12 months)
- Pain at rest (change baseline to -3, -6, -12 months)(0-12 months)
- Additional treatment(0-12 months)
- Complications(0-12 months)
- Objective function change baseline to -3, -6, -12 months(0-12 months)
研究者
Elin Swärd
MD, PhD
Karolinska Institutet