Effect of TENS on Hyperalgesia, Pain With Movement, and Function After TKR
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 317
- 试验地点
- 1
- 主要终点
- Self-Reported Pain With Movement
研究概览
简要总结
Our primary hypothesis is that TENS decreases pain with movement by reducing hyperalgesia. Minimizing the severe pain experienced during required activities in the immediate postoperative period will promote functional recovery and prevent the development of new chronic pain syndromes.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary osteoarthritis of the knee
- •Speak English
- •Unilateral total knee replacement
排除标准
- •No ambulation, assisted or otherwise
- •Use of TENS by subject in past 5 yrs
- •Current use of TENS by someone else in subject's household
- •Stroke or other condition which seriously impairs sensation in legs or ability to follow directions.
- •Condition that precludes use of TENS (pacemaker, allergy to nickel, etc.)
- •Chronic pain (other than in surgical knee) that is currently being treated or is severe. (Do not exclude for fibromyalgia).
研究组 & 干预措施
Active TENS
High-frequency intense TENS provided with the EMPI Select TENS. The generator emits a balanced, asymmetrical, biphasic waveform and has buttons for variation of frequency and amplitude. A rate modulation frequency of 50pps and 150pps every 0.5 seconds will be used with a pulse width of 150 microseconds (μs).
干预措施: Active TENS (Device)
Placebo TENS
Subjects randomized to the placebo group will use an EMPI TENS Select device that emits a current for 45 seconds then shuts off. They will be asked when they first feel the current, then the device will be turned down a half-point to provide "treatment" at a sub-sensory level. This unit displays an active indicator light suggesting to the subject that the unit is actively emitting current. At discharge, subject will be sent home with an adequate supply of batteries and asked to change batteries when the device goes below 4 bars, further suggesting that the device is actively working.
干预措施: Placebo TENS (Device)
Standard Care
Subjects randomized to "Standard Care" will be given no TENS unit.
结局指标
主要结局
Self-Reported Pain With Movement
时间窗: 1 day post-op
While subject's knee extension is measured, they report their pain on 0-20 Numeric Rating Scale (where 0 is "no pain" and 20 is "pain as bad as you can imagine").
Self-reported Pain With Walking (From Iowa Gait Test)
时间窗: 2 days post-op
Subjects are instructed to walk as quickly as they safely can for 15 seconds. Their pain was assessed with a Numeric Rating Scale (where 0 is "no pain" and 20 is "pain as bad as you can imagine").
次要结局
未报告次要终点
研究者
Barbara A Rakel
Professor
University of Iowa