Using Diffuse Noxious Inhibitory Control (DNIC) to Predict Acupuncture Therapy Outcome: A Pilot Study
Using DNIC to Predict Acupuncture Therapy Outcome: A Pilot Study
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable pain
Started Mar 2010
Shorter than P25 for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 12, 2010
CompletedFirst Posted
Study publicly available on registry
March 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedJune 19, 2013
June 1, 2013
4 months
March 12, 2010
June 17, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diffuse Noxious Inhibitory Control Efficiency
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.
Week 0, 2, 4, 6, and 12 of acupuncture therapy
Study Arms (1)
Acupuncture
OTHER14 weeks of electroacupuncture therapy.
Interventions
Eligibility Criteria
You may qualify if:
- Healthy women with a progesterone-coated intrauterine device (Mirena), and
- Men greater than or equal to 18 years old.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Washingtonlead
- Bastyr Universitycollaborator
Study Sites (1)
University of Washington
Seattle, Washington, 98195, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ruth Landau, MD
University of Washington
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Director of OB Anesthesia & Clinical Genetics Research
Study Record Dates
First Submitted
March 12, 2010
First Posted
March 17, 2010
Study Start
March 1, 2010
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
June 19, 2013
Record last verified: 2013-06