NCT01088867

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Mar 2010

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 17, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

June 19, 2013

Status Verified

June 1, 2013

Enrollment Period

4 months

First QC Date

March 12, 2010

Last Update Submit

June 17, 2013

Conditions

Keywords

PainAcupunctureDNICElectroacupuncture

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

OTHER

14 weeks of electroacupuncture therapy.

Other: Acupuncture

Interventions

Electroacupuncture

Also known as: Pantheon Electroacupuncture Device
Acupuncture

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Ruth Landau, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

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

Locations