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

March 12, 2010
June 17, 2013
March 2010
July 2010   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01088867 on ClinicalTrials.gov Archive Site
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Using Diffuse Noxious Inhibitory Control (DNIC) to Predict Acupuncture Therapy Outcome: A Pilot Study
Using DNIC to Predict Acupuncture Therapy Outcome: A Pilot Study

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.

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Interventional
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Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Pain
Other: Acupuncture
Electroacupuncture
Other Name: Pantheon Electroacupuncture Device
Acupuncture
14 weeks of electroacupuncture therapy.
Intervention: Other: Acupuncture
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
July 2010
July 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01088867
36255-A
No
Ruth Landau, University of Washington
University of Washington
Bastyr University
Principal Investigator: Ruth Landau, MD University of Washington
University of Washington
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP