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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 22, 2014