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

May 27, 2015 updated by: Gerhard M Hobusch, Medical University of Vienna

Efficiency Study About the Effect of Acupunctur on Postoperative Pain After Total Knee Arthroplastry

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 .

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

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Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Device: 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 Comparator: 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
Device: sham 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
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)
Other: PCA/NSAID
standard boli of morphine by pressing a button of PCA

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Vienna

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medical Scientific Fund of the Mayor of Vienna

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gerhard M Hobusch, Dr., Medical University of Vienna, Department of Orthopaedics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 25, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 28, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 28, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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