NCT02456116

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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 28, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

3 years

First QC Date

May 25, 2015

Last Update Submit

May 27, 2015

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • Amount of morphines/day

    Morphine PCRA (pain pump) administered to every patient

    1.-4.day postoperative

Secondary Outcomes (3)

  • movement abilities

    1.-4.day postoperative

  • Quality of Life (QOL)

    day -1/day 5

  • Pain intensity (VAS)

    1.-4.day postoperative

Study Arms (3)

acupuncture/PCA/NSAID

EXPERIMENTAL

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

sham acupuncture/PCA/NSAID

SHAM COMPARATOR

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

PCA/NSAID

OTHER

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

Interventions

acupuncture/PCA/NSAIDDEVICE

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

acupuncture/PCA/NSAID
sham acupuncture/PCA/NSAIDDEVICE

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

sham acupuncture/PCA/NSAID
PCA/NSAIDOTHER

standard boli of morphine by pressing a button of PCA

PCA/NSAID

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vienna General Hospital

Vienna, 1090, Austria

RECRUITING

Related Publications (3)

  • Lin JG, Chen WL. Review: acupuncture analgesia in clinical trials. Am J Chin Med. 2009;37(1):1-18. doi: 10.1142/S0192415X09006679.

    PMID: 19222107BACKGROUND

  • 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.

    PMID: 22712373BACKGROUND

  • 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.

    PMID: 17224599BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Gerhard M Hobusch, Dr.

    Medical University of Vienna, Department of Orthopaedics

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Reinhard Windhager, Prof. Dr.

CONTACT

+4314040040820reinhard.windhager@akhwien.at

Bernd Kubista, Prof. Dr.

CONTACT

+4314040040830bernd.kubista@meduniwien.ac.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

May 25, 2015

First Posted

May 28, 2015

Study Start

September 1, 2012

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

AU(1)