- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01088867
Using Diffuse Noxious Inhibitory Control (DNIC) to Predict Acupuncture Therapy Outcome: A Pilot Study
June 17, 2013 updated by: Ruth Landau, University of Washington
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98195
- University of Washington
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 58 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Acupuncture
14 weeks of electroacupuncture therapy.
|
Electroacupuncture
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Week 0, 2, 4, 6, and 12 of acupuncture therapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ruth Landau, MD, University of Washington
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
July 1, 2010
Study Completion (Actual)
July 1, 2010
Study Registration Dates
First Submitted
March 12, 2010
First Submitted That Met QC Criteria
March 16, 2010
First Posted (Estimate)
March 17, 2010
Study Record Updates
Last Update Posted (Estimate)
June 19, 2013
Last Update Submitted That Met QC Criteria
June 17, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 36255-A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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