Auricular Acupuncture in Postoperative Pain

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT01030029
Collaborator
Department of Anesthesiology, General Intensive Care Medicine and Pain Control (Other)
40
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2
25
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Study Details

Study Description

Brief Summary

The effect of acupuncture for postoperative pain control remains controversial. We therefore studied the effects of electrical auricular acupuncture (AA) on postoperative opioid consumption in a randomized, patient-blinded clinical trial.

40 female patients undergoing laparoscopy were included. Anaesthetized patients were randomly assigned to receive AA (shen men, thalamus and one segmental organ-specific point) or electrodes and electrical stimulation for 72 hours. Postoperatively patients received 1 g paracetamol every 6 hours and additional piritramide on demand. A blinded observer obtained the doses of piritramide and the visual analogue pain scores (VAS) at 0, 2, 24, 48, and 72 hours.

It was the aim of our study to find out, whether auricular acupuncture reduces postoperative pain.

Condition or Disease Intervention/Treatment Phase
  • Device: electrical auricular acupuncture
  • Device: P-Stim™ devices were applied without electrical stimulation and acupuncture.
Phase 4

Detailed Description

Postoperative pain treatment is a major issue in management of surgical patients. Goal of the treatment is a maximal effect with minimal side effects. There are various treatment options, including conventional pharmacological and complementary approaches. Acupuncture is a system with an empirical basis, which has been used in the treatment for centuries. The mechanisms can be partly explained in terms of endogenous pain inhibitory systems. Its use for pain relief has been supported by clinical trials and this has facilitated its use in pain clinics in most countries. Needle acupuncture and other forms of sensory stimulation produce similar physiological changes in humans and mammals, e.g. rhythmic discharges in nerve fibres, and the release of endogenous opioids. Besides acupuncture points located on "meridians" all over the body acupuncture points are also described on the ear. The stimulation of acupuncture points can be achieved by pressure, a mechanical action of needling, or electrical point stimulation. In chronic pain treatment acupuncture has been found to be more effective than other non-pharmacological therapies. Furthermore, continuous electrical stimulation of auricular acupuncture points improves the treatment of chronic cervical pain patients. Finally, acupuncture represents not only a therapeutically beneficial, but also a cost-effective treatment option. Auricular acupuncture is also known to be effective in treatment of acute postoperative pain.

The aim of our study is to investigate in a randomized, prospective, double - blind, and controlled design whether continuous electrical stimulation of auricular acupuncture points results in reduction of postoperative pain.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Auricular Acupuncture in Postoperative Pain: a Randomized Controlled Trail
Study Start Date :
Jan 1, 2006
Actual Primary Completion Date :
Dec 1, 2007
Actual Study Completion Date :
Feb 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: electrical auricular acupuncture

Patients in the acupuncture group received titan disposable needles (27-gauge, 3 mm length; Biegler GmbH, Mauerbach, Austria), which were inserted in the dominant ear at the following acupuncture points: shen men, thalamus and one segmental organ-specific point. Acupuncture points were identified by measuring skin resistance, using an electrical conductance meter (multipoint selection pen™, Biegler GmbH, Mauerbach, Austria). The needles were connected to the P-Stim™ device and received continuous low frequency electro acupuncture using P-Stim™ (constant current: 1 Hz biphasic, 2 mA) for 72 hours postoperatively. Acupuncture was performed by a specialist with 15 years experience in this technique.

Device: electrical auricular acupuncture
Patients in the acupuncture group received titan disposable needles (27-gauge, 3 mm length; Biegler GmbH, Mauerbach, Austria), which were inserted in the dominant ear at the following acupuncture points: shen men, thalamus and one segmental organ-specific point [2]. Acupuncture points were identified by measuring skin resistance, using an electrical conductance meter (multipoint selection pen™, Biegler GmbH, Mauerbach, Austria). The needles were connected to the P-Stim™ device and received continuous low frequency electro acupuncture using P-Stim™ (constant current: 1 Hz biphasic, 2 mA) for 72 hours postoperatively. Acupuncture was performed by a specialist with 15 years experience in this technique.
Other Names:
  • P-Stim® The stimulator consists of a microcontroller and a bit-coded ST62T60BM6 interface, which produce defined waves of electrical stimuli
  • Placebo Comparator: pstim device without acupuncture

    Patients in the control group received electrodes without needles and the P-Stim™ devices were applied without electrical stimulation.

    Device: P-Stim™ devices were applied without electrical stimulation and acupuncture.
    Patients in the control group received electrodes without needles and the P-Stim™ devices were applied without electrical stimulation.

    Outcome Measures

    Primary Outcome Measures

    1. mean postoperative pain (VAS score) [0,2,24,48,72 hours]

    Secondary Outcome Measures

    1. consumption of piritramide postoperatively [0,2,24,48,72 hours postoperatively]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • female ASA physical status I-III patients undergoing elective gynaecological laparoscopy

    • (surgery in cases of infertility, ovarian cyst removal, adhesiolysis, adnexal surgery,endometriosis, or hysterectomy),

    • aged from 18-60 years.

    Exclusion Criteria:
    • patients with a history of drug abuse,

    • regular use of sedatives,

    • chronic analgesic medication,

    • neurological or psychiatric diseases,

    • adverse reaction to sevoflurane or paracetamol,

    • ASA physical status > III,

    • pacemaker, or a history of acupuncture treatment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical University Vienna Vienna Austria 1090

    Sponsors and Collaborators

    • Medical University of Vienna
    • Department of Anesthesiology, General Intensive Care Medicine and Pain Control

    Investigators

    • Principal Investigator: Andrea Holzer, MD, Medical University Vienna, Department of Anesthesiology and General Intensive Care Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01030029
    Other Study ID Numbers:
    • 08/2009
    • 262/2005
    First Posted:
    Dec 10, 2009
    Last Update Posted:
    Apr 8, 2015
    Last Verified:
    Jan 1, 2006

    Study Results

    No Results Posted as of Apr 8, 2015