Partial Wrist Denervation Versus Self-managed Exercise Therapy in Patients with Wrist Osteoarthritis: a Randomized Controlled Multicenter Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- PRWE
研究概览
简要总结
A randomized controlled trial comparing partial wrist denervation to a self-managed exercise therapy program in 140 patients with wrist osteoarthritis.
详细描述
Backgroud:
High quality evidence regarding the effectiveness of non-operative and operative treatments in wrist osteoarthritis are lacking.
Aim:
To analyze:
- Does partial wrist denervation and self-managed exercise therapy improve patient-reported outcomes, pain, grip strength and range of motion (ROM) in wrist OA?
- Is any of the two treatment concepts partial wrist denervation and self-managed exercise therapy more efficient than the other in terms of patient-reported outcomes, pain relief, grip strength and range of motion?
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 assessors and analysts will be masked for treatment allocation (covered wrist / anonymous data sheet).
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 wrist pain (≥6 months) due to Scapholunate advanced collapse (SLAC) / Scaphoid non-union advanced collapse (SNAC) grade 1-3 osteoarthritis.
- •Radiological signs of osteoarthritis on posteroanterior and lateral radiograph.
排除标准
- •Previous PIN or AIN neurectomy.
- •Rheumatoid arthritis or other chronic inflammatory arthritis.
- •Symptomatic osteoarthritis in the distal radio-ulnar (DRU), Scapho-trapezio-trapezoid (STT) or thumb carpometacarpal (CMC) joints.
- •Ongoing infection.
- •Inability to co-operate with the follow-up protocol.
- •Systemic or intra-articular glucocorticoids or intraarticular PRP or Hyaluronic acid injections in the affected joint within 3 months prior to enrollment.
研究组 & 干预措施
Self-managed exercise therapy program
Exercise program focusing on functional re-learning and strengthening of the musculoskeletal system with the aim to create a stable wrist that can be used in a pain-free manner in activities of daily living.
干预措施: Self-managed exercise therapy program (Behavioral)
Partial wrist denervation
AIN and PIN neurectomy through a dorsal approach as described by Berger (Berger, 1998).
干预措施: Partial wrist denervation (Procedure)
结局指标
主要结局
PRWE
时间窗: 6 months
Patient Rated Wrist Evaluation (PRWE) score (0-100 (high score worse outcome)) (MacDermid et al., 1998)
次要结局
- GROC(5 years)
- Pain catastrophizing(5 years)
- PRWE(5 years)
- Pain NRS(5 years)
- EQ5D(5 years)
- ROM(5 years)
- Grip(5 years)
- Complications(5 years)
- Radiology(5 years)
- Cost(12 months)
- sick leave(12 months)
- work(12 months)
- Survival(5 years)
- EQ5D(12 months)
- GROC(3 months)
- ROM(6 months)
- Pain NRS(6 months)
- PRWE(3 months)
- PRWE(12 months)
- Pain NRS(3 months)
- EQ5D(6 months)
- Pain NRS(12 months)
- EQ5D(3 months)
- GROC(6 months)
- GROC(12 months)
- Pain catastrophizing(3 months)
- Pain catastrophizing(6 months)
- Pain catastrophizing(12 months)
- ROM(3 months)
- ROM(12 months)
- Grip(3 months)
- Grip(6 months)
- Grip(12 months)
- Complications(3 months)
- Complications(6 months)
- Complications(12 months)
- Survival(12 months)
研究者
Elin Swärd
Principal Investigator
Karolinska Institutet