Double Blind Placebo-controlled Clinical Trial to Assess Pulsed Shortwave Therapy as an Adjunct Pain Therapy & Knee Recovery for Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Visual Analogue Pain
研究概览
简要总结
This clinical study is designed to assesses the benefit of adding pulsed shortwave therapy to the postoperative pain and recovery protocol following total knee replacement. Pulsed shortwave therapy is a safe adjunct pain therapy for acute and chronic pain.
详细描述
Despite the recent advances in the understanding of pain mechanisms and the introduction of new drugs and new techniques in the postoperative management, pain after total knee arthroplasty (TKA) is still an unresolved issue. It affects the quality of life and rehabilitation of an important percentage of patients undergoing TKA. A recent study looked at the percentage of patients with chronic knee pain after knee replacement at a minimum of one year following surgery in 272 patients, 107 patients (nearly 40%) reported that they still had persistent pain at one-plus year following surgery. Central sensitization is now well established as an integral factor in many chronic pain states, including the commonly occurring knee and back pain. Many patients undergoing TKA are likely to have a significant degree of Central Sensitization, therefore the likely hood of high pain levels postoperative and persistent long standing pain after TKA is increased in this patient population.
Pulsed shortwave therapy negates central sensitization by imputing new
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria for knee osteoarthritis;
- •Planned spinal anesthesia; American Society of Anesthesiologists (ASA) physical status I-II;
- •Scheduled for unilateral TKA;
- •Patients aged 50 to 80 years old.
- •Willingness to give written informed consent and willingness to participate in and comply with the study.
排除标准
- •Unwillingness of the patient;
- •Presence of neuropathic pain or sensory disorders in the leg to be operated on;
- •Intolerance to the study drugs;
- •Failure of spinal anesthesia;
- •Previous major knee surgery, re-operation or trauma to the knee within the study period.
研究组 & 干预措施
Study Group
Pulsed shortwave therapy device used as an adjunct therapy immediately on the completion of the operation
干预措施: pulsed shortwave therapy (Device)
Control Group
Sham pulsed shortwave therapy device used as an adjunct therapy immediately on the completion of the operation
干预措施: pulsed shortwave therapy (Device)
结局指标
主要结局
Change in Visual Analogue Pain
时间窗: Change in pain levels over 3 months
The visual analog scale (VAS) has been used extensively for rating pain intensity in previous studies. Postoperative pain at 2, 6, 10, 18, 26, 34, 42, 50, 58, 64, and 72 hours after surgery will be recorded using a 10-cm horizontal line with 1-cm vertical lines at each end labeled "no pain" (left side) and "worst possible pain" (right side). VAS scores will also be recorded also at day 4, 7, 14 and 28 and finally at three months. Different time point assessments are being conducted to look at the change in pain level from baseline through recovery.
次要结局
- The Oxford Knee Score(3 months)
- Pain Pressure Threshold(3 months)
- The Knee Injury and Osteoarthritis Outcome Score(3 months)
- The Pain and Sleep Questionnaire three-item index(3 months)
- Active Range of Motion(3 months)
- Analgesic medication use(28 days)