Battlefield Auricular Acupuncture for Control of Post-partum Pain

NCT02526186 | Completed Results

• 1 other identifier: FWH20150072H
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Who Achieved 50% Sustained Pain Reduction

  measured daily from days 0-11.

  12 days

Secondary Outcomes (1)

• Morphine Equivalent Use

  12 days

Study Arms (2)

Standard of Care

NO INTERVENTION

Standard of Care only

Battlefield Auricular Acupuncture

EXPERIMENTAL

Standard of Care plus Battlefield Auricular Acupuncture

Device: Battlefield Auricular Acupuncture

Interventions

Battlefield Auricular Acupuncture DEVICE

Battlefield Auricular Acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Post-partum female (DoD beneficiaries).
• Age 18 years or older
• Pain score rating post-delivery of greater or equal to 4/10.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mike O'Callaghan Military Hospital: lead

Study Sites (1)

Mike O'Callaghan Federal Medical Center

Nellis Air Force Base, Nevada, 89191, United States

Location

Related Publications (2)

• 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.

  PMID: 33078388 DERIVED

• 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.

  PMID: 32871021 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Amanda Crawford
• Organization: MOMH

amanda.j.crawford.ctr@health.mil

7025633583

Study Officials

• Michael J Kim, MD

  Mike O'Callaghan Federal Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2015
• First Posted: August 18, 2015
• Study Start: February 1, 2016
• Primary Completion: May 20, 2018
• Study Completion: May 20, 2018
• Last Updated: March 27, 2024
• Results First Posted: March 27, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)