Pain
Conditions
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.
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.
Interventions
DEVICEBattlefield Auricular Acupuncture
Sponsors
Mike O'Callaghan Military Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY. Inclusion: * Post-partum female (DoD beneficiaries). * Age 18 years or older * Pain score rating post-delivery of greater or equal to 4/10. Exclusion: * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Who Achieved 50% Sustained Pain Reduction | 12 days | measured daily from days 0-11. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morphine Equivalent Use | 12 days | morphine equivalent units (total mg) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care Standard of Care only | 33 |
| Battlefield Auricular Acupuncture Standard of Care plus Battlefield Auricular Acupuncture
Battlefield Auricular Acupuncture | 37 |
| Total | 70 |
Baseline characteristics
| Characteristic | Standard of Care | Battlefield Auricular Acupuncture | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 33 Participants | 37 Participants | 70 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 5 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 4 Participants | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 25 Participants | 23 Participants | 48 Participants |
| Region of Enrollment United States | 33 participants | 37 participants | 70 participants |
| Sex: Female, Male Female | 33 Participants | 37 Participants | 70 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 37 |
| other Total, other adverse events | 0 / 33 | 0 / 37 |
| serious Total, serious adverse events | 0 / 33 | 0 / 37 |
Outcome results
Primary
Number of Subjects Who Achieved 50% Sustained Pain Reduction
measured daily from days 0-11.
Time frame: 12 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard of Care | Number of Subjects Who Achieved 50% Sustained Pain Reduction | day 2 | 3 # of subjects with 50% pain reduction |
| Standard of Care | Number of Subjects Who Achieved 50% Sustained Pain Reduction | day 0 | 0 # of subjects with 50% pain reduction |
| Standard of Care | Number of Subjects Who Achieved 50% Sustained Pain Reduction | day 1 | 2 # of subjects with 50% pain reduction |
| Standard of Care | Number of Subjects Who Achieved 50% Sustained Pain Reduction | day 3 | 4 # of subjects with 50% pain reduction |
| Standard of Care | Number of Subjects Who Achieved 50% Sustained Pain Reduction | day 4 | 8 # of subjects with 50% pain reduction |
| Standard of Care | Number of Subjects Who Achieved 50% Sustained Pain Reduction | day 5 | 12 # of subjects with 50% pain reduction |
| Standard of Care | Number of Subjects Who Achieved 50% Sustained Pain Reduction | day 6 | 16 # of subjects with 50% pain reduction |
| Standard of Care | Number of Subjects Who Achieved 50% Sustained Pain Reduction | day 7 | 17 # of subjects with 50% pain reduction |
| Standard of Care | Number of Subjects Who Achieved 50% Sustained Pain Reduction | day 8 | 20 # of subjects with 50% pain reduction |
| Standard of Care | Number of Subjects Who Achieved 50% Sustained Pain Reduction | day 9 | 24 # of subjects with 50% pain reduction |
| Standard of Care | Number of Subjects Who Achieved 50% Sustained Pain Reduction | day 10 | 25 # of subjects with 50% pain reduction |
| Standard of Care | Number of Subjects Who Achieved 50% Sustained Pain Reduction | day 11 | 28 # of subjects with 50% pain reduction |
| Battlefield Auricular Acupuncture | Number of Subjects Who Achieved 50% Sustained Pain Reduction | day 10 | 26 # of subjects with 50% pain reduction |
| Battlefield Auricular Acupuncture | Number of Subjects Who Achieved 50% Sustained Pain Reduction | day 6 | 17 # of subjects with 50% pain reduction |
| Battlefield Auricular Acupuncture | Number of Subjects Who Achieved 50% Sustained Pain Reduction | day 0 | 0 # of subjects with 50% pain reduction |
| Battlefield Auricular Acupuncture | Number of Subjects Who Achieved 50% Sustained Pain Reduction | day 9 | 26 # of subjects with 50% pain reduction |
| Battlefield Auricular Acupuncture | Number of Subjects Who Achieved 50% Sustained Pain Reduction | day 1 | 6 # of subjects with 50% pain reduction |
| Battlefield Auricular Acupuncture | Number of Subjects Who Achieved 50% Sustained Pain Reduction | day 2 | 9 # of subjects with 50% pain reduction |
| Battlefield Auricular Acupuncture | Number of Subjects Who Achieved 50% Sustained Pain Reduction | day 7 | 21 # of subjects with 50% pain reduction |
| Battlefield Auricular Acupuncture | Number of Subjects Who Achieved 50% Sustained Pain Reduction | day 3 | 11 # of subjects with 50% pain reduction |
| Battlefield Auricular Acupuncture | Number of Subjects Who Achieved 50% Sustained Pain Reduction | day 11 | 27 # of subjects with 50% pain reduction |
| Battlefield Auricular Acupuncture | Number of Subjects Who Achieved 50% Sustained Pain Reduction | day 4 | 12 # of subjects with 50% pain reduction |
| Battlefield Auricular Acupuncture | Number of Subjects Who Achieved 50% Sustained Pain Reduction | day 8 | 22 # of subjects with 50% pain reduction |
| Battlefield Auricular Acupuncture | Number of Subjects Who Achieved 50% Sustained Pain Reduction | day 5 | 15 # of subjects with 50% pain reduction |
Secondary
Morphine Equivalent Use
morphine equivalent units (total mg)
Time frame: 12 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care | Morphine Equivalent Use | 88 total mg | Standard Deviation 58 |
| Battlefield Auricular Acupuncture | Morphine Equivalent Use | 82 total mg | Standard Deviation 113 |