Battlefield Acupuncture for Acute/Subacute Back Pain in the Emergency Department
NCT ID: NCT03996564
Last Updated: 2019-06-26
Study Results
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Basic Information
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COMPLETED
NA
26 participants
INTERVENTIONAL
2016-02-22
2016-12-12
Brief Summary
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Detailed Description
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Design and Methods: A prospective, randomized control trial, (un-blinded, non-placebo controlled) with convenience sampling based on scheduled clinical shifts in the Emergency Department.
The population consisted of active duty service members and Department of Defense beneficiaries (dependents and retirees) at the DoD's sole Level I trauma center, San Antonio Military Medical Center Emergency Department with acute/subacute, or acute/subacute on chronic back pain as the chief complaint. The participants studied age range was from 18-55 years old without concern for pathological back pain.
Subjects were selected based on their chief complaint identified by the triage nurse. A randomized convenience sampling method was used while members of the research team were on shift. Subjects were informed of the study once they were triaged at the Emergency Department treatment area. Members were screened for pathological back pain by history and physical, and if negative were offered enrollment into the study. After informed consent and Health Insurance Portability and Accountability Act (HIPPA), demographics were collected as well as an initial Visual Analog Score (VAS) score, Numeric Rating Scale (NRS) score, and back pain functional scale (BPFS). Participants were randomly assigned to either the treatment or control group based on a random number generator. Subjects then received either BFA or the standard care, which was a pre-determined medicinal treatment. Participants were reassessed at 30-40 minutes post intervention for effectiveness of intervention for both pain and satisfaction. After initial pain control was achieved subjects completed a questionnaire on their perceived effectiveness of BFA as well as if they would repeat BFA in the future. If participants did not feel pain was adequately controlled in the either treatment arm they were provided rescue pain medications based on the preference of the treating provider. At discharge, participants were given further instructions including a follow-up telephone interview between 48-72 hours. In the telephone follow-up, participants were assessed on a Numerical Rating Scale (NRS), repeat functionality questionnaire, and if they used any other pain medications since discharge to help improve their pain (either pain medications given at discharge from the emergency department or their regularly prescribed pain medications).
Data Analysis: In this study, the independent variables were treatment for musculoskeletal pain in the emergency department (standard care, battlefield acupuncture) and time (before treatment, 30 to 40 minutes post-treatment and 48 to 72 hours post-treatment). The dependent variable is pain measured on a VAS or NRS at 48-72 hours post-treatment. The null hypothesis is that there is no statistically significant difference in pain related to treatment or time between treatment groups. With 26 subjects per group (52 total), the investigator was able to detect a 1.0 standard deviation (SD) difference measured by a 13mm change in the VAS or a 2 point change in the NRS.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Acupuncture Group
Battlefield Acupuncture (BFA) has a structured administration sequence that was utilized to limit any variability between investigators administering the treatment. The BFA technique has been suggested that the needles are placed not just in an acupoint but actually "acupoint zones." BFA utilizes one to ten (maximum five points per ear) ASP semi-permanent gold needles® placed in one or both ears. The ASP Gold needle® is a sterile device which inserts a small 2 mm needle into the auricle. It is comprised in single-needle applicator ensuring ease of insertion combined with excellent precision. The needles remain in the ear and fall out spontaneously as early as two hours and up to seven days. After administration of the BFA, if subjects felt that their pain was not controlled based on verbal response, rescue medication could be administered to control pain to a tolerable level for discharge.
Battlefield Acupuncture
1-10 needles inserted in systematic nature as described by Battlefield acupuncture protocol.
Standard Care Group
Participants randomized to the standard care group were treated with one, or a combination of selected medications to include oral Acetaminophen 500mg-1000mg, Diclofenac 50mg-75 mg orally, Diazepam 5mg-10 mg intravenous or oral, Hydrocodone 5mg/325mg-10mg/650mg mg oral, or intramuscular Ketorolac 30mg-60 mg, as deemed appropriate by the treating investigator (medical provider). Standard treatment was administered by the investigators based on the patient's presentation and driving status as many of the medications cannot be administered if the subject would operate a vehicle. No standardized algorithm was specified and the route and dose of medications was administered at the provider's discretion. After administration of the traditional standard care medications, if subjects felt their pain was not controlled based on verbal responses, rescue medication would be given to control pain to a more tolerable level for discharge.
Acetaminophen
Acetaminophen 500mg-1000mg,
Diclofenac
Diclofenac 50mg-75 mg orally
Diazepam
Diazepam 5mg-10 mg intravenous or oral
Hydrocodone
Hydrocodone 5mg/325mg-10mg/650mg mg
Ketorolac
oral, or intramuscular Ketorolac 30mg-60 mg
Interventions
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Battlefield Acupuncture
1-10 needles inserted in systematic nature as described by Battlefield acupuncture protocol.
Acetaminophen
Acetaminophen 500mg-1000mg,
Diclofenac
Diclofenac 50mg-75 mg orally
Diazepam
Diazepam 5mg-10 mg intravenous or oral
Hydrocodone
Hydrocodone 5mg/325mg-10mg/650mg mg
Ketorolac
oral, or intramuscular Ketorolac 30mg-60 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Emergency Room patient
* Able to provide informed consent (of sound mind)
* acute defined as less than 3 months, or acute on chronic musculoskeletal pain
* Individuals will be between 18-55 years of age and include Active Duty (AD) service members and beneficiaries
* Pain at prescreening will be greater than or equal to 3 based on the Visual Analogue Scale (VAS).
* Non-pathological acute back pain
Exclusion Criteria
* temperature \>38.0 Celsius
* suspected fractures
* pain associated with diseases (flank/kidney pain)
* concern for other than back pain (pyelonephritis, kidney stones, pathologic signs and symptoms)
* bowel/bladder incontinence or retention
* foot drop
* known current/history of cancer
* known bleeding disorders
* active infection at the needled insertion site
* If member is found to be pregnant at any time during screening process they will be removed from consideration before any treatment options are offered.
18 Years
55 Years
ALL
Yes
Sponsors
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San Antonio Military Medical Center
FED
Responsible Party
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Kyle Johnston
Principal Investigator
Principal Investigators
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Timothy Bonjour, DSc
Role: PRINCIPAL_INVESTIGATOR
Program Director
References
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Other Identifiers
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C.2016.017d
Identifier Type: -
Identifier Source: org_study_id
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