Acute PainNCT00253994
Auricular Acupuncture for Acute Pain
A study testing Acupuncture in people with Acute Pain, run by Samueli Institute for Information Biology at 1 site in United States.
Trial summary
Auricular Acupuncture in the Treatment of Acute Pain Syndromes (AATAPS) Study Period: August 1, 2003 - December 31, 2004 Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Acute Pain
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to Dec 2004
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of acute pain syndrome
- Written Informed Consent
- Over the age of 18
Who cannot join
- Unwilling or unable to participate in study treatment and follow-up
- Require medical intervention other than pain management
- Pregnant or nursing
- Unable to give informed consent for any reason
- Extreme pain
- Allergic reaction to adhesive tape, gold or other components of the acupuncture needles
- Admitted to the hospital for care
Trial locations and contacts
1 site in 1 country.
United States1 site
Malcolm Grow Medical Center, Andrews Air Force Base
Andrews Air Force Base, Maryland, 20762
About this study
Official title: Auricular Acupuncture in the Treatment of Acute Pain Syndromes (AATAPS) Pilot
- Auricular Acupuncture in the Treatment of Acute Pain Syndromes (AATAPS)
- Study Period: August 1, 2003 - December 31, 2004
Read the detailed description
Although inroads in the study of acupuncture for acute pain conditions have been made, there are still critical gaps in the literature in both basic/mechanistic and clinical areas. Very little is know about what impact conservative, easily transportable and administered treatments, such as acupuncture, might have in preserving military battlefield readiness. The proposed research proposal is an incremental step with the ultimate goal to increase the knowledge base and expand clinical applications of acupuncture for acute pain conditions that are relevant to military personnel and operations.The purpose of this proposal is to conduct a scientifically rigorous investigation of auricular acupuncture for the treatment of acute pain in the emergency room setting at a military hospital using a two phase clinical trial design. This pragmatic investigation will provide a unique opportunity to develop clinically relevant questions that can be further evaluated in the context of basic science and more robust clinical trial designs. The specific aims of this study are to 1) Determine the feasibility of conducting a clinical trial of auricular acupuncture in the treatment of military personnel with acute pain who present to the emergency room at Andrews Air Force Base, using a pilot two phase clinical trial approach and 2) Gather data on the effect size of auricular acupuncture in treating acute pain conditions. Persons presenting to the emergency room at Malcolm Grow with acute pain syndromes that do not require medical attention beyond pain management strategies will be invited to participate in the study and asked for informed consent. The study will involve a preliminary pilot test period during which 20 persons are entered into a consecutive case series study to test the feasibility of collecting data and implementing the treatment procedures in the busy emergency room setting. Treatment will involve auricular acupuncture using SEDATELEC Aiguille Semi-Permanent (ASP) needles bilaterally at two acupuncture points - Cingulate Gyrus and Thalamic Nuclei. Baseline demographic and pain indicator information will be collected prior to treatment. Follow-up data on pain levels and medication use will occur prior to leaving the ER and 24 hours following treatment. The primary endpoint is change in pain levels at 24 hours, as measured by the verbal Numerical Rating Scale (NRS). 24 hour follow-up will occur via the telephone. Following successful completion of the preliminary study, a two arm, randomized clinical pilot trial of 100 participants (N = 50 per arm) will be conducted using the same protocol as the case series study. Patients will be randomized to either usual emergency medical care or acupuncture + medical co-management. Follow-up data will be collected on the schedule outlined above by assessors blinded to treatment assignment.
- 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.
The primary endpoint was current level of pain, as measured by the verbal Numerical Rating Scale (NRS
Measured: Before leaving the ER; 24 hours post-treatment
Secondary outcomes (1)
Change in Medication Use, if any
Measured: Baseline; 24 hours post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startAug 2003
- Study completionDec 2004
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
- 100 participants
Sponsor and investigators
- Lead sponsor
- Samueli Institute for Information Biology
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Investigators
- Christine Goertz, DC, PhD, Principal investigator, Samueli Institute for Information Biology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00253994
- Sponsor's protocol ID
- MIL-03-01
- Other IDs
- MGMC IRB #: FMG20030009H
- Status last verified
- Sep 2007
- First submitted
- 10 Nov 2005
- 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
- Auricular Acupuncture in the Treatment of Acute Pain Syndromes (AATAPS) Pilot
- ClinicalTrials.gov ID
- NCT00253994
- Acronym / sponsor ID
- MIL-03-01
- Conditions
- Acute Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Samueli Institute for Information BiologyUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Aug 2003
- Study completion
- Dec 2004 (actual)
- First posted
- 15 Nov 2005 (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.
- Auricular Acupuncture in the Treatment of Acute Pain Syndromes (AATAPS)
- Study Period: August 1, 2003 - December 31, 2004
Detailed description
Although inroads in the study of acupuncture for acute pain conditions have been made, there are still critical gaps in the literature in both basic/mechanistic and clinical areas. Very little is know about what impact conservative, easily transportable and administered treatments, such as acupuncture, might have in preserving military battlefield readiness. The proposed research proposal is an incremental step with the ultimate goal to increase the knowledge base and expand clinical applications of acupuncture for acute pain conditions that are relevant to military personnel and operations.The purpose of this proposal is to conduct a scientifically rigorous investigation of auricular acupuncture for the treatment of acute pain in the emergency room setting at a military hospital using a two phase clinical trial design. This pragmatic investigation will provide a unique opportunity to develop clinically relevant questions that can be further evaluated in the context of basic science and more robust clinical trial designs. The specific aims of this study are to 1) Determine the feasibility of conducting a clinical trial of auricular acupuncture in the treatment of military personnel with acute pain who present to the emergency room at Andrews Air Force Base, using a pilot two phase clinical trial approach and 2) Gather data on the effect size of auricular acupuncture in treating acute pain conditions. Persons presenting to the emergency room at Malcolm Grow with acute pain syndromes that do not require medical attention beyond pain management strategies will be invited to participate in the study and asked for informed consent. The study will involve a preliminary pilot test period during which 20 persons are entered into a consecutive case series study to test the feasibility of collecting data and implementing the treatment procedures in the busy emergency room setting. Treatment will involve auricular acupuncture using SEDATELEC Aiguille Semi-Permanent (ASP) needles bilaterally at two acupuncture points - Cingulate Gyrus and Thalamic Nuclei. Baseline demographic and pain indicator information will be collected prior to treatment. Follow-up data on pain levels and medication use will occur prior to leaving the ER and 24 hours following treatment. The primary endpoint is change in pain levels at 24 hours, as measured by the verbal Numerical Rating Scale (NRS). 24 hour follow-up will occur via the telephone. Following successful completion of the preliminary study, a two arm, randomized clinical pilot trial of 100 participants (N = 50 per arm) will be conducted using the same protocol as the case series study. Patients will be randomized to either usual emergency medical care or acupuncture + medical co-management. Follow-up data will be collected on the schedule outlined above by assessors blinded to treatment assignment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis of acute pain syndrome
- Written Informed Consent
- Over the age of 18
Key exclusion criteria (7 listed)
- Unwilling or unable to participate in study treatment and follow-up
- Require medical intervention other than pain management
- Pregnant or nursing
- Unable to give informed consent for any reason
- Extreme pain
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
The primary endpoint was current level of pain, as measured by the verbal Numerical Rating Scale (NRS
Time frame: Before leaving the ER; 24 hours post-treatment
1 secondary outcome
Change in Medication Use, if any
Time frame: Baseline; 24 hours post-treatment
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.
Christine Goertz, DC, PhD principal investigator
Samueli Institute for Information Biology
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 3 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?
The primary endpoint was current level of pain, as measured by the verbal Numerical Rating Scale (NRS (time frame: Before leaving the ER; 24 hours post-treatment). 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.