NCT00286390

Brief Summary

The purpose of this project is to conduct a scientifically rigorous investigation of the clinical outcomes, quality of life, and cost associated with the delivery of acupuncture in the treatment of acute and chronic pain in patients at Malcolm Grow Medical Center, Andrews Air Force Base. The specific aims of this study are to:

  1. 1.Gather outcomes and patient satisfaction data on patients receiving acupuncture treatment for acute and chronic pain.
  2. 2.Perform an analysis of costs, including any system cost savings, associated with providing acupuncture services to pain patients.
  3. 3.Serve as a model to expand the project to Scott AFB and Travis AFB as per the request of the Air Mobility Command Surgeon General. (AMC/SG).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2005

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, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2006

Completed
Last Updated

September 5, 2007

Status Verified

September 1, 2007

First QC Date

February 1, 2006

Last Update Submit

September 4, 2007

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

  • Level of Pain at Conclusion of Study, as measured by using a 0-10 Numerical Rating Scale (NRS)

    Baseline; Final assessment

Secondary Outcomes (1)

  • Pain Level, as measured by using a 0-10 Numerical Rating Scale (NRS) and Medication Use

    Baseline; Immediately after tx; 24 hours after tx

Interventions

AcupuncturePROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Western diagnosis of acute or chronic pain syndromes
  • Previously treated western standard of care
  • Written Informed Consent
  • Over the age of 18

You may not qualify if:

  • Unwilling or unable to participate in study treatment and follow-up
  • Unable to give informed consent for any reason
  • Allergic reaction to adhesive tape, gold or other components of the acupuncture needles
  • Pregnancy
  • Pacemaker
  • Electronic stimulator of any sort
  • Herbal preparations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malcolm Grow Medical Center (MGMC), Andrews Air Force Base

Andrews Air Force Base Census Designated Place, Maryland, 20762, United States

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • COL Richard C Niemtzow, MD, PhD, MPH

    United States Air Force

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 1, 2006

First Posted

February 3, 2006

Study Start

March 1, 2005

Study Completion

February 1, 2006

Last Updated

September 5, 2007

Record last verified: 2007-09

Locations

US(1)