Efficiency Study About the Effect of Acupunctur on Postoperative Pain After Total Knee Arthroplastry
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Amount of morphines/day
研究概览
简要总结
The purpose of this study is to evaluate the use of needle acupuncture in comparison to a conventional postoperative pain management in terms of reducing pain and pain medication use in an interdisciplinary setting in a controlled, randomized study design after implantation of total knee arthroplasty .
详细描述
- Patients and Methods
1.1 All patients will be treated at the Medical University of Vienna and receive a TKA due to advanced gonarthrosis. The study includes male and female patients. Every patient who is admitted for a TKA ( Total knee arthroplasty) implant is invited to take part in the study. Exclusion criteria: renal insufficiency, cardial insufficiency, coronary heart disease, use of morphines, hydrocodones, benzodiazepines before surgery.
1.2 The acupuncture is carried out using sterile disposable acupuncture needles, steel with a copper coil, size 0.25 x 30 mm by experienced acupuncturists and students in their third training year of the post graduate TCM (traditionel chinese medicine) training course of the Medical University of Vienna. The standard acupuncture was compiled as a traditional Chinese conventional body and ear/auricular acupuncture by a consortium of acupuncture professors as follows: Body acupuncture, pricked from both sides, the depth of the prick 0.5 - 1 cm, according to the technique of traditional Chinese acupuncture a DeQI (a sensation in the area of the acupuncture or in the course of the corresponding meridian) released. Regarding the frequency: ear acupuncture needles are bitten only postoperatively and can be left for a period of 4 until 7 postoperative days . The body acupuncture needling is carried out at the points of question once a day for a period of about 20 minutes , starting at the first preoperative day, continuating the day of surgery and 2nd and 4th postoperative day.
In sham acupuncture the given acupuncture points are pricked 2-3 centimetres from the defined point.
The group of patients who is not receiving any acupuncture and only used the PCA (Patient Controlled Analgesia) pain pump therapy is chosen as a control group. The pain pump therapy is not the subject of this clinical study and is routinely used for postoperative pain in TKA operations and does not need any evaluation.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with advanced osteoarthritis of the knee (primary and secondary reasons)
- •planned surgical procedure TKA
排除标准
- •renal insufficiency
- •cardial insufficiency
- •coronary heart disease
- •regular therapeutic use of morphines, hydrocodones, benzodiazepines before surgery.
结局指标
主要结局
Amount of morphines/day
时间窗: 1.-4.day postoperative
Morphine PCRA (pain pump) administered to every patient
次要结局
- movement abilities(1.-4.day postoperative)
- Pain intensity (VAS)(1.-4.day postoperative)
- Quality of Life (QOL)(day -1/day 5)
研究者
Gerhard M Hobusch
Dr.
Medical University of Vienna