Low-level Laser Acupuncture Reduces Postoperative Pain and Morphine-related Side Effects in Patients With Total Knee Arthroplasty: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- The Numerical Rating Scale (NRS)
研究概览
简要总结
Total knee arthroplasty is a common and effective surgical procedure for patients with end-stage knee osteoarthritis, and wound pain is still a problem for many of the patients.
详细描述
Therefore, the purpose of this study was to apply low level laser therapy Measured variables included postoperative pain intensity, patient-controlled analgesia requirements, side effects caused by morphine, knee stiffness and wound pain in the daily activities of patients undergoing total knee arthroplasty. Data were collected between April 2018 and January 2019. Eighty-two knee osteoarthritis patients receiving total knee arthroplasty were recruited from one hospital and randomly, equally assigned to the laser acupuncture or control group. The LA group received the low-level laser therapy with 3 joules at each acupuncture point at Hour 2, Hour 6, Hour 10, Hour 24, Hour 48, and Hour 72 after surgery; whereas the control group received the same manner except for joule.
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 (Participant)
入排标准
- 年龄范围
- 60 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 60 years or older
- •American Sociological Association (ASA) class I-III
- •spinal anesthesia, consent to patient-controlled analgesia (PCA) and peripheral nerve block (PNB)
- •return to the ward directly from the anesthesia recovery room.
排除标准
- •cutaneous lesions at the application sites
- •use of taking immunosuppressive agents
- •received intra-articular steroid treatment
- •opiate dependence
- •sensitive to light
- •clinically significant cardiovascular diseases
- •systemic lupus erythematosus.
研究组 & 干预措施
low-level laser therapy
808nM wavelength, power density of 300mW
干预措施: low-level laser (Device)
Sham laser acupuncture treatment
received the same manner except for joule.
干预措施: Sham laser (Device)
结局指标
主要结局
The Numerical Rating Scale (NRS)
时间窗: the first 72 hours after the surgery
NRS was assessed pain intensity, ranging from 0 (no pain) to 10 (worst pain imaginable).higher scores, higher pain.
Brief Pain Inventory (BPI)
时间窗: the first 72 hours after the surgery
The patients answered or pointed their pain on 0-to-10 scales (0=no pain, 10=extreme pain) at the time of responding to the BPI(current pain), and also at the items of "the most severe pain", "the least pain", and "the average pain" in the last 24 hours. Using the BPI, patients were also asked to rate pain-related interference in daily activities, including general activity, mood, walking ability, normal work, relations with other people, sleeping, and enjoyment of life. The anchor points, in each items of interference scale, were 11-point NRSs (0=no interference, 10=interferes completely).
次要结局
未报告次要终点