PainNCT02526186
Battlefield Auricular Acupuncture for Control of Post-partum Pain
A study testing Battlefield Auricular Acupuncture in people with Pain, run by Mike O'Callaghan Military Hospital at 1 site in United States.
Trial summary
We will conduct a randomized controlled trial to determine whether the addition of battlefield auricular acupuncture to standard of care is effective for control of postpartum pain for mothers in the immediate post-partum period. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Battlefield Auricular Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 20 May 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Post-partum female (DoD beneficiaries).
- Age 18 years or older
- Pain score rating post-delivery of greater or equal to 4/10.
Who cannot join
- Absence of one or more ears
- Active cellulitis of ear
- Ear anatomy precluding identification of acupuncture landmarks
- Non-English speaking
- Use of Hearing Aids that preclude the use of ear acupuncture
- Known allergy to gold
Trial locations and contacts
1 site in 1 country.
United States1 site
Mike O'Callaghan Federal Medical Center
Nellis Air Force Base, Nevada, 89191
About this study
We will conduct a randomized controlled trial to determine whether the addition of battlefield auricular acupuncture to standard of care is effective for control of postpartum pain for mothers in the immediate post-partum period. Post-partum patients (DoD beneficiaries) 18 years or older, regardless of gravida/parity, who plan to have a childbirth in a hospital setting will be offered the opportunity to participate in the study through PCM referrals and posted advertisements. After a minimum of 6 hours post-vaginal delivery or 24 hours post caesarean section subjects will be given treatment according to their randomization group. Subjects will be assessed on pain control, overall satisfaction with pain management, and the amount of pharmacological pain medications used. Safety of measures will also be assessed to include infection rates, syncope, vertigo, and hypotension.
Read the detailed description
Screening Visit:
- Obtain signed Informed Consent document and HIPAA Authorization.
- Review past medical history in Armed Forces Health Longitudinal Technology Application (AHLTA) to verify the inclusion/exclusion criteria and including previous encounter, vital signs review, medication list, co-morbidities, demographics, problems list, prior obstetric history, and note any prior acupuncture received.
- Record: Date of birth, age, gender, race, ethnicity, last 4 of social security number, current email address.
Randomization: Subjects will then be randomized into one of two groups by one of the Research Coordinators using a random number generator:
- Group 1: Standard of care only.
- Group 2: Standard of care plus Battlefield acupuncture at treatment sites Cingulate gyrus, thalamus, omega 2, shen-men, point zero in both ears (see figures 1-5). The 5 needles will remain in each ear for up to 7 days or allowed to fall out on their own (the patient will be instructed not to remove the needles).
- Subject's ears will be cleansed with an alcohol swab
- Subjects will be given a handout of standard BFA Discharge Instructions including what an infection looks like and what to do in the event of an infection (see attached).
Visit 1: Will occur after a minimum of 6 hours post vaginal birth (up until hospital discharge) to avoid disturbing maternal infant bonding or a minimum of 24 hours post caesarean section to avoid confounding with the anesthesia:
- Subject will be given treatment according to their randomization group.
- All subjects, regardless of randomization group, will be instructed to have no heavy meals, no excessive hot or cold foods, no heavy exercise or intercourse, and no alcohol for 6 hours.
- Satisfaction with post-partum pain management will be assessed with the following questions:
- On a scale of 0 to 10, how satisfied were you with your pain management after delivery? (dissatisfied 0 - 10 very satisfied)
- Would you use auricular acupuncture for future pain management? (Yes or no) (for those in the acupuncture group only)
- On a scale of 0-10, with 10 being the worst pain, what is your level of pain?
In hospital data collection: Data will be collected each day until the patient has been discharged from the hospital. Subjects will be contacted either in person or via phone and the hospital stay will vary from patient to patient:
- We will review the subject's medical record and record RN Recorded Pain assessments, Delivery method (either Caesarean section or spontaneous vaginal delivery), Delivery complications (vaginal lacerations, use of episiotomy, operative vaginal delivery, shoulder dystocia, post-partum hemorrhage), Birth weight, Maternal Parity, and record what pain medications they are taking.
- We will ask subjects if they prefer to be contacted in-person or via telephone while in the hospital.
- Satisfaction with post-partum pain management will be assessed with the following questions:
- On a scale of 0 to 10, how satisfied were you with your pain management after delivery? (dissatisfied 0 - 10 very satisfied)
- Would you use auricular acupuncture for future pain management? (Yes or no) (for those in the acupuncture group only)
- On a scale of 0-10, with 10 being the worst pain, what is your level of pain?
- Are the needles still in place? If yes, how many in each ear?
Post hospital discharge: Each day up until 10 days post Visit 1. Subjects will be contacted phone and the following information will be collected:
- Satisfaction with post-partum pain management will be assessed with the following questions:
- On a scale of 0 to 10, how satisfied were you with your pain management after delivery? (dissatisfied 0-10 very satisfied)
- Would you use auricular acupuncture for future pain management? (Yes or no) (for those in the acupuncture group only)
- On a scale of 0-10, with 10 being the worst pain, what is your level of pain? • We will record what pain medications they are taking including drug name, strength, and total doses since discharge from the hospital.
- Conditions
- Pain
- Being tested
- Battlefield Auricular Acupuncture
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Battlefield Auricular AcupunctureDevice
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Standard of Care only |
| Battlefield Auricular Acupuncture | Experimental | Standard of Care plus Battlefield Auricular Acupuncture Receives: Device: Battlefield Auricular Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Who Achieved 50% Sustained Pain Reduction
measured daily from days 0-11.
Measured: 12 days
Secondary outcomes (1)
Morphine Equivalent Use
morphine equivalent units (total mg)
Measured: 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study startFeb 2016
- Primary completion20 May 2018
- Study completion20 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mike O'Callaghan Military Hospital
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Michael J Kim, MD, Principal investigator, Mike O'Callaghan Federal Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02526186
- Sponsor's protocol ID
- FWH20150072H
- Status last verified
- Feb 2024
- First submitted
- 14 Aug 2015
- Last updated
- 27 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Deussen AR, Ashwood P, Martis R, Stewart F, Grzeskowiak LE. Relief of pain due to uterine cramping/involution after birth. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD004908. doi: 10.1002/14651858.CD004908.pub3.
PubMed 33078388Zimpel SA, Torloni MR, Porfirio GJ, Flumignan RL, da Silva EM. Complementary and alternative therapies for post-caesarean pain. Cochrane Database Syst Rev. 2020 Sep 1;9(9):CD011216. doi: 10.1002/14651858.CD011216.pub2.
PubMed 32871021
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Battlefield Auricular Acupuncture for Control of Post-partum Pain
- ClinicalTrials.gov ID
- NCT02526186
- Acronym / sponsor ID
- FWH20150072H
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Mike O'Callaghan Military HospitalUS federal agency
- Study start
- Feb 2016 (actual)
- Primary completion
- 20 May 2018 (actual)
- Study completion
- 20 May 2018 (actual)
- First posted
- 18 Aug 2015 (estimated)
- Results
- Posted 27 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We will conduct a randomized controlled trial to determine whether the addition of battlefield auricular acupuncture to standard of care is effective for control of postpartum pain for mothers in the immediate post-partum period. Post-partum patients (DoD beneficiaries) 18 years or older, regardless of gravida/parity, who plan to have a childbirth in a hospital setting will be offered the opportunity to participate in the study through PCM referrals and posted advertisements. After a minimum of 6 hours post-vaginal delivery or 24 hours post caesarean section subjects will be given treatment according to their randomization group. Subjects will be assessed on pain control, overall satisfaction with pain management, and the amount of pharmacological pain medications used. Safety of measures will also be assessed to include infection rates, syncope, vertigo, and hypotension.
Detailed description
Screening Visit:
- Obtain signed Informed Consent document and HIPAA Authorization.
- Review past medical history in Armed Forces Health Longitudinal Technology Application (AHLTA) to verify the inclusion/exclusion criteria and including previous encounter, vital signs review, medication list, co-morbidities, demographics, problems list, prior obstetric history, and note any prior acupuncture received.
- Record: Date of birth, age, gender, race, ethnicity, last 4 of social security number, current email address.
Randomization: Subjects will then be randomized into one of two groups by one of the Research Coordinators using a random number generator:
- Group 1: Standard of care only.
- Group 2: Standard of care plus Battlefield acupuncture at treatment sites Cingulate gyrus, thalamus, omega 2, shen-men, point zero in both ears (see figures 1-5). The 5 needles will remain in each ear for up to 7 days or allowed to fall out on their own (the patient will be instructed not to remove the needles).
- Subject's ears will be cleansed with an alcohol swab
- Subjects will be given a handout of standard BFA Discharge Instructions including what an infection looks like and what to do in the event of an infection (see attached).
Visit 1: Will occur after a minimum of 6 hours post vaginal birth (up until hospital discharge) to avoid disturbing maternal infant bonding or a minimum of 24 hours post caesarean section to avoid confounding with the anesthesia:
- Subject will be given treatment according to their randomization group.
- All subjects, regardless of randomization group, will be instructed to have no heavy meals, no excessive hot or cold foods, no heavy exercise or intercourse, and no alcohol for 6 hours.
- Satisfaction with post-partum pain management will be assessed with the following questions:
- On a scale of 0 to 10, how satisfied were you with your pain management after delivery? (dissatisfied 0 - 10 very satisfied)
- Would you use auricular acupuncture for future pain management? (Yes or no) (for those in the acupuncture group only)
- On a scale of 0-10, with 10 being the worst pain, what is your level of pain?
In hospital data collection: Data will be collected each day until the patient has been discharged from the hospital. Subjects will be contacted either in person or via phone and the hospital stay will vary from patient to patient:
- We will review the subject's medical record and record RN Recorded Pain assessments, Delivery method (either Caesarean section or spontaneous vaginal delivery), Delivery complications (vaginal lacerations, use of episiotomy, operative vaginal delivery, shoulder dystocia, post-partum hemorrhage), Birth weight, Maternal Parity, and record what pain medications they are taking.
- We will ask subjects if they prefer to be contacted in-person or via telephone while in the hospital.
- Satisfaction with post-partum pain management will be assessed with the following questions:
- On a scale of 0 to 10, how satisfied were you with your pain management after delivery? (dissatisfied 0 - 10 very satisfied)
- Would you use auricular acupuncture for future pain management? (Yes or no) (for those in the acupuncture group only)
- On a scale of 0-10, with 10 being the worst pain, what is your level of pain?
- Are the needles still in place? If yes, how many in each ear?
Post hospital discharge: Each day up until 10 days post Visit 1. Subjects will be contacted phone and the following information will be collected:
- Satisfaction with post-partum pain management will be assessed with the following questions:
- On a scale of 0 to 10, how satisfied were you with your pain management after delivery? (dissatisfied 0-10 very satisfied)
- Would you use auricular acupuncture for future pain management? (Yes or no) (for those in the acupuncture group only)
- On a scale of 0-10, with 10 being the worst pain, what is your level of pain? • We will record what pain medications they are taking including drug name, strength, and total doses since discharge from the hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Standard of Care only |
| Battlefield Auricular Acupuncture | Experimental | Device: Battlefield Auricular AcupunctureStandard of Care plus Battlefield Auricular Acupuncture |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Post-partum female (DoD beneficiaries).
- Age 18 years or older
- Pain score rating post-delivery of greater or equal to 4/10.
Key exclusion criteria (6 listed)
- Absence of one or more ears
- Active cellulitis of ear
- Ear anatomy precluding identification of acupuncture landmarks
- Non-English speaking
- Use of Hearing Aids that preclude the use of ear acupuncture
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 |
|---|---|---|
| Battlefield Auricular Acupuncture | Device | Battlefield Auricular Acupuncture |
Primary outcome
Number of Subjects Who Achieved 50% Sustained Pain Reduction
Time frame: 12 days
measured daily from days 0-11.
1 secondary outcome
Morphine Equivalent Use
Time frame: 12 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33078388Deussen AR, Ashwood P, Martis R, Stewart F, Grzeskowiak LE. Relief of pain due to uterine cramping/involution after birth. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD004908. doi: 10.1002/14651858.CD004908.pub3.
- Derived from this study: PubMed 32871021Zimpel SA, Torloni MR, Porfirio GJ, Flumignan RL, da Silva EM. Complementary and alternative therapies for post-caesarean pain. Cochrane Database Syst Rev. 2020 Sep 1;9(9):CD011216. doi: 10.1002/14651858.CD011216.pub2.
- Individual participant dataSharing planned: No
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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.
Michael J Kim, MD principal investigator
Mike O'Callaghan Federal Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Battlefield Auricular Acupuncture in people with Pain, run by Mike O'Callaghan Military Hospital 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 6 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 27 Mar 2024. 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?
Yes. Results are posted in the registry (first posted 27 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects Who Achieved 50% Sustained Pain Reduction (time frame: 12 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02526186, which also lists 2 linked publications.
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 27 Mar 2024.