Using Diffuse Noxious Inhibitory Control (DNIC) to Predict Acupuncture Therapy Outcome: A Pilot Study

This study has been completed.
Sponsor:
Collaborator:
Bastyr University
Information provided by (Responsible Party):
Ruth Landau, University of Washington
ClinicalTrials.gov Identifier:
NCT01088867
First received: March 12, 2010
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

The investigators hypothesize that acupuncture modifies the DNIC efficiency and that DNIC can serve as a predictor to identify 'good responders' to acupuncture early in therapy.


Condition Intervention
Pain
Other: Acupuncture

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Using DNIC to Predict Acupuncture Therapy Outcome: A Pilot Study

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Diffuse Noxious Inhibitory Control Efficiency [ Time Frame: Week 0, 2, 4, 6, and 12 of acupuncture therapy ] [ Designated as safety issue: No ]
    The efficiency of diffuse noxious inhibitory control (DNIC) is a measure of one's ability to inhibit pain perception. DNIC efficiency is assessed by a psychophysical test that involves a heat thermode as the "test stimulus" and a warm water bath as the "conditioning stimulus". The results of this test will be used as the primary outcome measure.


Enrollment: 10
Study Start Date: March 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Acupuncture
14 weeks of electroacupuncture therapy.
Other: Acupuncture
Electroacupuncture
Other Name: Pantheon Electroacupuncture Device

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy women with a progesterone-coated intrauterine device (Mirena), and
  • Men greater than or equal to 18 years old.

Exclusion Criteria:

  • Acupuncture treatment in the previous six weeks, to discount any persisting effect of acupuncture.
  • Treatment of a pain condition with pain medication.
  • Regular use of benzodiazepines.
  • Skin diseases, such as scleroderma, psoriasis or eczema.
  • An adverse event due to acupuncture therapy.
  • Pregnant women.
  • Women without a progesterone-coated intrauterine device (Mirena).
  • Anyone older than 60 years of age, fatigued, with a pacemaker ICD, artificial joint, prolonged bleeding time/hemophilia, open wounds, or a known susceptibility to profound analgesia after acupuncture treatment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01088867

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Bastyr University
Investigators
Principal Investigator: Ruth Landau, MD University of Washington
  More Information

No publications provided

Responsible Party: Ruth Landau, Professor, Director of OB Anesthesia & Clinical Genetics Research, University of Washington
ClinicalTrials.gov Identifier: NCT01088867     History of Changes
Other Study ID Numbers: 36255-A
Study First Received: March 12, 2010
Last Updated: June 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Pain
Acupuncture
DNIC
Electroacupuncture

ClinicalTrials.gov processed this record on April 15, 2014