Efficiency Study About the Effect of Acupunctur on Postoperative Pain After Total Knee Arthroplastry
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Medical University of Vienna
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Amount of morphines/day
Study Overview
Brief Summary
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 .
Detailed Description
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients with advanced osteoarthritis of the knee (primary and secondary reasons)
- •planned surgical procedure TKA
Exclusion Criteria
- •renal insufficiency
- •cardial insufficiency
- •coronary heart disease
- •regular therapeutic use of morphines, hydrocodones, benzodiazepines before surgery.
Arms & Interventions
PCA/NSAID
minimal intervention (included in every arm) standard boli of morphine by pressing a button of PCA availability in the postoperative period (day 0-4) readout once a day NSAID (non-steroid antiinflammatory drug) 2x i.v. (75mg diclofenac-sodium, 30 mg orphenadrine citrate) (day 0-4)
Intervention: PCA/NSAID (Other)
acupuncture/PCA/NSAID
standard program with defined points:
- Ear acupuncture needles bitten once (day 0-5)
- Body acupuncture, once a day 20 minutes (day -1/ 0/ 2/ 4), depth of the prick 0.5 - 1 cm, with DeQI feeling/sensation is released
Intervention: acupuncture/PCA/NSAID (Device)
sham acupuncture/PCA/NSAID
standard program with defined points:
- Ear sham-acupuncture needles bitten once (day 0-5)
- Body sham-acupuncture, once a day 20 minutes (day -1/ 0/ 2/ 4), depth of the prick 0.5
Intervention: sham acupuncture/PCA/NSAID (Device)
Outcomes
Primary Outcomes
Amount of morphines/day
Time Frame: 1.-4.day postoperative
Morphine PCRA (pain pump) administered to every patient
Secondary Outcomes
- Quality of Life (QOL)(day -1/day 5)
- movement abilities(1.-4.day postoperative)
- Pain intensity (VAS)(1.-4.day postoperative)
Investigators
Gerhard M Hobusch
Dr.
Medical University of Vienna