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

Pain Clinical Trial

Official title:

Using DNIC to Predict Acupuncture Therapy Outcome: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01088867
• Other study ID #: 36255-A
• Status: Completed
• Phase: N/A
• First received: March 12, 2010
• Last updated: June 17, 2013
• Start date: March 2010
• Est. completion date: July 2010

Study information

• Verified date: June 2013
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• Acupuncture
Electroacupuncture

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Bastyr University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No