Effects of Transcutaneous Electrical Nerve Stimulation (TENS) on Postoperative Pain and Function Following Arthroscopic Knee Surgery: A Prospective Randomized Clinical Trial Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy.
研究概览
简要总结
Following standard of care procedures for arthroscopy knee surgery it is anticipated that Transcutaneous Electrical Nerve Stimulation (TENS) will provide improved pain relief and improve functional outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-60
- •No significant joint malalignment
- •No significant ligamentous instability
- •No significant radiographic joint space narrowing
- •No prior significant knee surgery
- •Unilateral knee surgery
- •Not workman's compensation
- •Planned knee arthroscopy for meniscectomy, chondroplasty or synovectomy
排除标准
- •Age <18 or >60
- •BMI > 50
- •Significant joint malalignment
- •Significant ligamentous instability
- •Significant radiographic joint space narrowing
- •Prior significant knee surgery
- •Bilateral knee surgery planned
- •Worker's Compensation
- •No planned knee arthroscopy for menisectomy, chondroplasty or synovectomy
研究组 & 干预措施
Structured TENS Therapy
This group will be given an active TENS unit to use.
干预措施: TENS Treatment with functional or disabled unit (Device)
Sham TENS Therapy
This group will receive a placebo TENS unit which has been functionally disabled to provide a short initial electrical impulse then cease delivering that impulse.
干预措施: TENS Treatment with functional or disabled unit (Device)
结局指标
主要结局
Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy.
时间窗: Two weeks postoperatively.
The patient participant will record pain levels during the immediate post-op 2-week time period every day. Day 0 is pain level before surgery. Pain perception measured on a scale from 0-10 with 0 representing no or lowest level pain and 10 representing the highest level of pain
次要结局
未报告次要终点