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.
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
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:
- Gather outcomes and patient satisfaction data on patients receiving acupuncture treatment for acute and chronic pain.
- Perform an analysis of costs, including any system cost savings, associated with providing acupuncture services to pain patients.
- 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:
- To assess perceived health outcomes after acupuncture treatment by military medical acupuncturists.
- To identify psychosocial and demographic predictors of perceived health outcomes from acupuncture treatment by military medical acupuncturists.
- 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.
AcupunctureProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted3 Feb 2006 (estimated)
- Study startMar 2005
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Samueli Institute for Information Biology
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Investigators
- COL Richard C Niemtzow, MD, PhD, MPH, Principal investigator, United States Air Force
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes and Cost Assessment of Acupuncture in the Treatment (OCAT) of Pain Patients at Malcolm Grow USAF Medical Center
- ClinicalTrials.gov ID
- NCT00286390
- Acronym / sponsor ID
- CRO-04-01
- Conditions
- Acute Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Samueli Institute for Information BiologyUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Mar 2005
- Study completion
- Feb 2006 (actual)
- First posted
- 3 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Gather outcomes and patient satisfaction data on patients receiving acupuncture treatment for acute and chronic pain.
- Perform an analysis of costs, including any system cost savings, associated with providing acupuncture services to pain patients.
- 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).
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:
- To assess perceived health outcomes after acupuncture treatment by military medical acupuncturists.
- To identify psychosocial and demographic predictors of perceived health outcomes from acupuncture treatment by military medical acupuncturists.
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Western diagnosis of acute or chronic pain syndromes
- Previously treated western standard of care
- Written Informed Consent
- Over the age of 18
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture | Procedure or surgery | – |
Primary outcome
Level of Pain at Conclusion of Study, as measured by using a 0-10 Numerical Rating Scale (NRS)
Time frame: Baseline; Final assessment
1 secondary outcome
Pain Level, as measured by using a 0-10 Numerical Rating Scale (NRS) and Medication Use
Time frame: Baseline; Immediately after tx; 24 hours after tx
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
COL Richard C Niemtzow, MD, PhD, MPH principal investigator
United States Air Force
1 site in 1 country: see every site and its status.
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.