Efficiency Study About the Effect of Acupuncture on Postoperative Pain After Total Knee Arthroplasty

Not Applicable

• Conditions: Pain, Postoperative
• Interventions: Device: acupuncture/PCA/NSAID; Device: sham acupuncture/PCA/NSAID; Other: PCA/NSAID

• Registration Number: NCT02456116
• Lead Sponsor: Medical University of Vienna

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

1. 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.

2. 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 Timeline

• Study Start: 2012-09
• Status Verified: 2015-05
• Study First Submitted: 2015-05-25
• Study First Submitted QC: 2015-05-27
• Last Update Submitted: 2015-05-27
• Study First Posted: 2015-05-28
• Last Update Posted: 2015-05-28
• Primary Completion: 2015-09
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• patients with advanced osteoarthritis of the knee (primary and secondary reasons)
• planned surgical procedure TKA

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Exclusion Criteria

• renal insufficiency
• cardial insufficiency
• coronary heart disease
• regular therapeutic use of morphines, hydrocodones, benzodiazepines before surgery.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
acupuncture/PCA/NSAID	acupuncture/PCA/NSAID	standard program with defined points: 1. Ear acupuncture needles bitten once (day 0-5) 2. 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
sham acupuncture/PCA/NSAID	sham acupuncture/PCA/NSAID	standard program with defined points: 1. Ear sham-acupuncture needles bitten once (day 0-5) 2. Body sham-acupuncture, once a day 20 minutes (day -1/ 0/ 2/ 4), depth of the prick 0.5
PCA/NSAID	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)

Primary Outcome Measures

Name	Time	Method
Amount of morphines/day	1.-4.day postoperative	Morphine PCRA (pain pump) administered to every patient

Secondary Outcome Measures

Name	Time	Method
Quality of Life (QOL)	day -1/day 5	SF36 (short form 36)
movement abilities	1.-4.day postoperative	range of motion/Knee society score
Pain intensity (VAS)	1.-4.day postoperative

Trial Locations

Locations (1)

Vienna General Hospital; 🇦🇹 Vienna, Austria