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

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ClinicalTrials.gov Identifier: NCT01088867
Recruitment Status : Completed
First Posted : March 17, 2010
Last Update Posted : June 19, 2013
Sponsor:
Collaborator:
Bastyr University
Information provided by (Responsible Party):
Ruth Landau, University of Washington

Brief Summary:
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 or disease Intervention/treatment Phase
Pain Other: Acupuncture Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Using DNIC to Predict Acupuncture Therapy Outcome: A Pilot Study
Study Start Date : March 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture
U.S. FDA Resources

Arm Intervention/treatment
Acupuncture
14 weeks of electroacupuncture therapy.
Other: Acupuncture
Electroacupuncture
Other Name: Pantheon Electroacupuncture Device



Primary Outcome Measures :
  1. Diffuse Noxious Inhibitory Control Efficiency [ Time Frame: Week 0, 2, 4, 6, and 12 of acupuncture therapy ]
    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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: March 17, 2010    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: June 2013

Keywords provided by Ruth Landau, University of Washington:
Pain
Acupuncture
DNIC
Electroacupuncture