A Two-Arm, Single-Blinded Randomized Controlled Trial Evaluating the Effectiveness of Mechanical Modalities Combined With Standard Therapy Versus Standard Therapy Alone for Edema and Pain Management After Distal Radius Fracture Fixation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Edema Volume
研究概览
简要总结
This single-blinded, randomized controlled trial (RCT) will evaluate the added benefit of mechanical modalities (continuous passive motion (CPM) and intermittent pneumatic compression (IPC)) when integrated into standard therapy for managing postoperative edema and pain in patients undergoing distal radius fracture (DRF) fixation. The primary outcomes are edema volume (measured via volumeter) and pain intensity (Numeric Pain Rating Scale, NPRS) at 6 weeks post-operation. Secondary outcomes include wrist/forearm range of motion (ROM), grip strength, Patient-Rated Wrist Evaluation (PRWE), and adverse events.
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)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older. Undergoing surgical treatment for distal radius fracture with stable internal fixation.
- •Able to initiate formal rehabilitation approximately 2 weeks postoperatively. Willing and able to attend in-clinic therapy sessions at the outpatient hand therapy center.
排除标准
- •Unstable fixation or need for further surgical intervention. Pre-existing conditions that would significantly affect upper limb function (e.g., severe arthritis, neurological disorders).
- •History of skin conditions or allergies that contraindicate the use of mechanical devices.
- •Any contraindication to mechanical modalities (for example, severe peripheral vascular disease).
- •Inability to comply with study procedures or follow-up visits. Pregnant or breastfeeding individuals.
研究组 & 干预措施
Mechanical Modality Group (MMG)
Participants in the MMG will undergo a combined intervention that utilizes mechanical modalities in addition to a standard rehabilitation program.
干预措施: Continuous Passive Motion (CPM) (Device)
Mechanical Modality Group (MMG)
Participants in the MMG will undergo a combined intervention that utilizes mechanical modalities in addition to a standard rehabilitation program.
干预措施: Intermittent Pneumatic Compression (IPC) (Device)
Mechanical Modality Group (MMG)
Participants in the MMG will undergo a combined intervention that utilizes mechanical modalities in addition to a standard rehabilitation program.
干预措施: Standard Therapy Program (Behavioral)
Standard Care Group (SCG)
Participants in the SCG will receive the standard rehabilitation program alone without the application of mechanical devices.
干预措施: Standard Therapy Program (Behavioral)
结局指标
主要结局
Edema Volume
时间窗: Assessed at baseline (2 weeks postoperatively) and at 6 weeks post-operation.
Edema of the wrist/forearm will be quantitatively measured using a volumeter method. Lower volumes are indicative of reduced swelling.
Pain Intensity
时间窗: Assessed at baseline (2 weeks postoperatively) and at 6 weeks post-operation.
Pain is measured using the Numeric Pain Rating Scale (NPRS), with scores ranging from 0 (no pain) to 10 (worst pain imaginable).
次要结局
- Wrist/Forearm Range of Motion (ROM)(Measured at baseline, 6 weeks, and 3 months postoperatively.)
- Grip Strength(Assessed at baseline, 6 weeks, and 3 months postoperatively.)
- Incidence of Adverse Events(Continuously monitored from baseline to the 3-month follow-up.)