Combined Effect of Laser Acupuncture and Electroacupuncture in Knee Osteoarthritis Patients: a Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change of Visual Analog Score
研究概览
简要总结
Background:
Knee osteoarthritis (KOA) is a common degenerative joint disorder affected 250 million people globally. It can not only result in disability, but also associated with cardiovascular disease and mortality. The most common treatment for KOA is non-steroidal anti-inflammatory drug. However, the effect of analgesic is limited and may complicate with side effect. Hence, many patients search for complementary and alternative medicine. Acupuncture is one of the most popular complementary treatment with good analgesic effect and less side effect. Electroacupuncture (EA) or laser acupuncture (LA) was reported effective in pain control in knee osteoarthritis patients. However, there is no study about combination effect of EA and LA.
Methods:
This protocol is a randomized controlled trial investigating the combination effect of EA and LA on KOA. Fifty participants diagnosed KOA with aged more than 50 years old and knee pain more than 3 months were recruited and randomly assigned to the experimental group (EA plus LA) or sham group (EA plus LA without laser output) in clinical research center. The subjects will undergo EA plus LA treatment thrice a weeks for 4 weeks. The experimental group will receive acupuncture at GB33, GB34, SP9, SP10, and ST36 with transcutaneous electrical nerve stimulator on the GB34+33 and SP9+10., and the LA deliver 6 Joule of energy at EX-LE5, ST35, and BL40. The subjects in sham group will receive the same way but the LA is without any laser output. Outcome measurement will include visual analogue scale (VAS), Western Ontario McMaster Universities Osteoarthritis Index (WOMAC), Knee injury and osteoarthritis outcome (KOOS), body composition analysis, knee range of motion test, muscle stiffness test, standing on one foot test, and the 30-second chair stand test before intervention and after 4 weeks intervention. The result will be analyze and compared between the experimental group and sham group using the paired t test and one-way analysis of variance.
Objectives:
The aim of this protocol is to investigate the combination effect of EA and LA in KOA patients.
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, Investigator)
盲法说明
Sham LA is using the same appearance of LaserPen without energy output to perform the same acupoint as above description
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •VAS more than 3 point when daily activity
- •Kellgren-Lawrence Grading Scale grade 1 to 3 on knee X-ray
- •Provided informed consent
排除标准
- •History of knee arthroplasty, traumatic injury related joint deformity,
- •Body mass index more than 35
- •pacemaker insertion, photosensitivity
- •who had undergone intra-articular injection or acupuncture in recent one month
- •other factors that may affect the evaluation of the outcome, such as psychiatric disorder or moderate mental retardation etc.
结局指标
主要结局
Change of Visual Analog Score
时间窗: Through study completion, an average of 4 weeks
Visual Analog Score for pain during activity; change from baseline at 4 weeks; scoring from 0 to 10, and the higher scores indicate the worse condition
Use of analgesics
时间窗: Through study completion, an average of 4 weeks
Frequency of analgesics
次要结局
- Change of the score of Western Ontario and McMaster Universities Arthritis Index(Through study completion, an average of 4 weeks)
- Change of the minutes of standing on one foot test(Through study completion, an average of 4 weeks)
- Change of the times of 30-second chair stand test(Through study completion, an average of 4 weeks)
- Change of the percentage of Knee Injury and Osteoarthritis Outcome Score(Through study completion, an average of 4 weeks)
- Change of the angle of knee range of motion(Through study completion, an average of 4 weeks)
- Change of the muscle stiffness of quadriceps(Through study completion, an average of 4 weeks)