Application of a Unique Vibration Modality for Postoperative Pain Control in Patients With Distal Radius Fractures to Reduce Postoperative Pain and Opioid Use
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Pain Visual Analog Scale (VAS)
研究概览
简要总结
The purpose of this research study is to determine if using a vibration tool improves pain control after surgical treatment of distal radius fracture. Additionally, the investigators would like to determine if this tool has any impact on consumption of pain medications postoperatively.
详细描述
Traditionally, occupational therapists have utilized vibration for sensory re-education in compression neuropathies and peripheral nerve injuries. Vibration is also commonly used for desensitization of hypersensitivity following amputation, crush injury, and for hypersensitive scarring. Since the vibration tool is readily available in the hand therapy clinic, vibration analgesia should be further explored in the hand clinic to help reduce pain. Vibration is a simple, and non-invasive, tool and would be easy, economical, and practical to implement into the hand clinic for postoperative pain control. This research project will evaluate whether vibration can be a useful adjunct to current postoperative pain modalities. With a multidisciplinary approach, the investigators hope to highlight the use of non-opioid modalities of pain control in distal radius fractures and believe that the findings from this study may apply to other painful conditions of the hand as well.
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
- None
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
- •Patients with a distal radius fracture who have undergone an open reduction and internal fixation using a volar FCR approach with a single volar plate
- •Patients who can read, write, and follow direction in English
- •Willing to undergo occupational therapy at Northwestern Medicine's Hand Surgery clinic
排除标准
- •Patients undergoing oncologic surgery
- •Patients who undergo simultaneous surgery such as open carpal tunnel
- •Patients who only require closed reduction of distal radius fractures
- •Operative patients that require dorsal plate fixation or separate radial styloid plate fixation
研究组 & 干预措施
Vibration tool
Use of the vibration tool 3 times per day for 10 minutes for each session Morning, mid-day, and evening.
Volarly for 5 minutes and dorsally for 5 minutes, for a total of 10 minutes during each session:
干预措施: Vibration tool (Device)
Control
Standard of care, no vibration tool.
结局指标
主要结局
Pain Visual Analog Scale (VAS)
时间窗: up to 8 weeks post-surgery
Scored from 0 (no pain) to 10 (worst possible pain)
QuickDASH (Disabilities of the Arm, Shoulder, and Hand) Questionnaire
时间窗: up to 8 week post-surgery
An 11-item, self-report questionnaire designed to measure physical function and symptoms in patients with any or several musculoskeletal disorders of the upper limb; scored from 0 (no disability) to 100 (most severe disability).
PROMIS Bank v1.1 - Pain Interference Computer Adaptive Test
时间窗: up to 8 weeks post-surgery
A 4-6 item self-reported questionnaire designed to measure the consequences of pain on relevant aspects of a person's life; the T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10; low scores represent less pain interference, while high scores represent greater interference.
PROMIS Bank v2.0 - Upper Extremity Computer Adaptive Test
时间窗: up to 8 weeks post-surgery
A 4-6 item self-reported questionnaire designed to measure upper extremity function; the T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation of 10; low scores represent less function, while high scores represent greater function.
次要结局
- Opioid Use(up to 8 weeks post-surgery)
研究者
Jason Ko
Associate Professor
Northwestern University