Using Diffuse Noxious Inhibitory Control (DNIC) to Predict Acupuncture Therapy Outcome: A Pilot Study
This study has been completed.
Sponsor:
University of Washington
Collaborator:
Bastyr University
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT01088867
First received: March 12, 2010
Last updated: September 13, 2010
Last verified: September 2010
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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
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, MD, University of Washington |
| ClinicalTrials.gov Identifier: | NCT01088867 History of Changes |
| Other Study ID Numbers: | 36255-A |
| Study First Received: | March 12, 2010 |
| Last Updated: | September 13, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Washington:
|
Pain Acupuncture DNIC Electroacupuncture |
ClinicalTrials.gov processed this record on May 16, 2013