- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02456116
Efficiency Study About the Effect of Acupuncture on Postoperative Pain After Total Knee Arthroplasty (APOPKA)
Efficiency Study About the Effect of Acupunctur on Postoperative Pain After Total Knee Arthroplastry
Study Overview
Status
Conditions
Intervention / Treatment
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.
1.3 Randomising
Patients who agree to take part in the study are randomised and blinded for the surgeon into 3 groups regarding the planned pain therapy.
For postoperative pain therapy all patients receive, an on demand pain pump with morphine with controlled amounts of analgesics. The groups were formed on the assumption of a 30% reduction of pain using acupuncture in a power analysis with α=…… assuming 3 groups with 30 people each.: The method of randomising occurs as a sequence.
The blinding applied especially to the surgeon and the patients who received real and sham acupuncture.
- Outcome measures:
The primary aim is to find out if additive pain therapy in the form of body and ear/auricular acupuncture can effectively prove pain reduction after TKA implantation.
The amount of applied analgesics on every postoperative day (1.-5.) defines the command variable. The efficiency of acupuncture should be measured accordingly to the reduction of the on demand pain pump therapy.
Secondary objectives are the VAS of every postoperative day (1.-5.), the assessment of the operated leg's mobility as well as peri-operative nausea.
The intensity of pain is recorded as follows:
A) indirectly using the protocol of the amount of morphine administered by the PCA pump B) measuring pain by VAS (routinely 3 x daily)
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Reinhard Windhager, Prof. Dr.
- Phone Number: +4314040040820
- Email: reinhard.windhager@akhwien.at
Study Contact Backup
- Name: Bernd Kubista, Prof. Dr.
- Phone Number: +4314040040830
- Email: bernd.kubista@meduniwien.ac.at
Study Locations
-
-
-
Vienna, Austria, 1090
- Recruiting
- Vienna General Hospital
-
Contact:
- Bernd Kubista, Prof. Dr.
- Phone Number: +4314040040830
- Email: bernd.kubista@meduniwien.ac.at
-
Contact:
- Gerhard M Hobusch, Dr.
- Phone Number: +4314040040830
- Email: gerhard.hobusch@meduniwien.ac.at
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: acupuncture/PCA/NSAID
standard program with defined points:
|
standard program with defined points:
|
Sham Comparator: sham acupuncture/PCA/NSAID
standard program with defined points:
|
standard program with defined points:
|
Other: 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)
|
standard boli of morphine by pressing a button of PCA
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Amount of morphines/day
Time Frame: 1.-4.day postoperative
|
Morphine PCRA (pain pump) administered to every patient
|
1.-4.day postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
movement abilities
Time Frame: 1.-4.day postoperative
|
range of motion/Knee society score
|
1.-4.day postoperative
|
Quality of Life (QOL)
Time Frame: day -1/day 5
|
SF36 (short form 36)
|
day -1/day 5
|
Pain intensity (VAS)
Time Frame: 1.-4.day postoperative
|
1.-4.day postoperative
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Gerhard M Hobusch, Dr., Medical University of Vienna, Department of Orthopaedics
Publications and helpful links
General Publications
- Lin JG, Chen WL. Review: acupuncture analgesia in clinical trials. Am J Chin Med. 2009;37(1):1-18. doi: 10.1142/S0192415X09006679.
- Wang JF, Bao HX, Cai YH, Zhang JH, Tong PJ. [Case-control study on application of auricular acupuncture for the treatment of analgesia during perioperative period in total hip arthroplasty]. Zhongguo Gu Shang. 2012 Mar;25(3):220-3. Chinese.
- Usichenko TI, Kuchling S, Witstruck T, Pavlovic D, Zach M, Hofer A, Merk H, Lehmann C, Wendt M. Auricular acupuncture for pain relief after ambulatory knee surgery: a randomized trial. CMAJ. 2007 Jan 16;176(2):179-83. doi: 10.1503/cmaj.060875.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Anti-Inflammatory Agents, Non-Steroidal
Other Study ID Numbers
- KP13067BGMPOA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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