AzTrials
AzTrials

Acute PainNCT00286390

Acupuncture for Acute and Chronic Pain in Air Force Personnel

A study testing Acupuncture in people with Acute Pain, run by Samueli Institute for Information Biology at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Pain
What is being tested?
Acupuncture
Type of treatment
Surgery or procedure
How many people
200 participants
Where
1 siteUnited States
Study dates
Mar 2005to Feb 2006
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Malcolm Grow Medical Center (MGMC), Andrews Air Force Base

    Andrews Air Force Base, Maryland, 20762

Other trials in United States

About this study

Official title: Outcomes and Cost Assessment of Acupuncture in the Treatment (OCAT) of Pain Patients at Malcolm Grow USAF Medical Center

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. Gather outcomes and patient satisfaction data on patients receiving acupuncture treatment for acute and chronic pain.
  2. Perform an analysis of costs, including any system cost savings, associated with providing acupuncture services to pain patients.
  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).
Read the detailed description

Adult patients referred to the MGMC Acupuncture Clinic for this study must have an established Western medical diagnosis, have exhausted all standards of care for the reduction and/or resolution of pain, meet the inclusion and exclusion criteria and be clinically evaluated prior to entry in the study. 1000 patients will be entered into the study; no male and female patient ratios will be required. Patients under 18 years of age will be excluded. There are no upper age limits.

Acupuncture point(s) selection and acupuncture techniques will be individualized for each patient. All treatments will be approved by the physician principal investigator. Treatment will generally be administered with the patient either prone, supine, or seated position. Standards of reporting interventions in controlled trials of acupuncture, based on STRICTA requirements, will be followed. The following acupuncture data will be collected:

  • Acupuncture point locations (palpation or electronic detection)
  • Techniques employed: (e.g. dry needling, acupuncture, electro-acupuncture , auriculotherapy, electro-auriculotherapy, laser, piezo-electrical stimulation micro-current techniques, E-field)
  • Types of needles employed (e.g. ASP gold/stainless steel, needle tacks, Seirin needles, etc.)

Baseline demographic data and information on pain levels (using the Numerical Rating Scale), patient satisfaction (using the Patient Satisfaction Questionnaire), functional health status (using the SF-8), and concomitant medical care (including medication use) will be collected prior to treatment. Follow-up data on pain levels and concomitant medical care will be collected via telephone 24 hours, 1 week, 2 weeks, and 4 weeks post-therapy. Patient satisfaction and functional health status data will be collecetd again at 4 weeks post-treatment. Relapses of pain will be noted and appropriately evaluated. In addition, the following clinical data will be collected:

  • Subjective, Objective, Assessment, and Treatment(SOAP) parameters
  • Medication use
  • Range of motion

A cost analysis will be performed by comparing patients who seek acupuncture treatment to those who receive only conventional medical care during the same time period, by matching cohorts based on ICD-9 diagnostic codes and basic demographic information.

A series of appropriate parametric and nonparametric tests will be performed to look for pre-post differences in patient outcomes on a number of relevant baseline variables; including demographic information, intensity and duration of pain, SF-8 scores, patient satisfaction, and utilization of concomitant medical services.

An ancillary study will be conducted to investigate personality factors and pretreatment expectations as predictors of treatment outcome of medical acupuncture. Specific Aims of this ancillary study include:

  1. To assess perceived health outcomes after acupuncture treatment by military medical acupuncturists.
  2. To identify psychosocial and demographic predictors of perceived health outcomes from acupuncture treatment by military medical acupuncturists.
  3. To help clarify which patients are more likely to respond to acupuncture and hence more likely to benefit from a referral to a trained medical acupuncturist.
Conditions
Acute Pain
Being tested
Acupuncture
Medical subject headings
Acute Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Baseline; Final assessment

Secondary outcomes (1)
  1. Pain Level, as measured by using a 0-10 Numerical Rating Scale (NRS) and Medication Use

    Measured: Baseline; Immediately after tx; 24 hours after tx

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2006 (estimated)
  2. Study startMar 2005
  3. Study completionFeb 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
200 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00286390
Sponsor's protocol ID
CRO-04-01
Other IDs
FMG2005-0002H
Status last verified
Sep 2007
First submitted
1 Feb 2006
Last updated
5 Sep 2007
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing Acupuncture in people with Acute Pain, run by Samueli Institute for Information Biology at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Level of Pain at Conclusion of Study, as measured by using a 0-10 Numerical Rating Scale (NRS) (time frame: Baseline; Final assessment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2007.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in