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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.

Completed

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

Official record
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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

Other trials in United States

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 groups in NCT02526186
Study groupRoleWhat they receive
Standard of CareNo interventionStandard of Care only
Battlefield Auricular AcupunctureExperimentalStandard 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.

  1. Number of Subjects Who Achieved 50% Sustained Pain Reduction

    measured daily from days 0-11.

    Measured: 12 days

Secondary outcomes (1)
  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.

  1. First posted18 Aug 2015 (estimated)
  2. Study startFeb 2016
  3. Primary completion20 May 2018
  4. Study completion20 May 2018

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
70 participants (actual)
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
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 33078388
  • Zimpel 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

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.

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