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Low Back Pain, MechanicalNCT03996564

Battlefield Acupuncture for Acute/Subacute Back Pain in the Emergency Department

A study testing Battlefield Acupuncture, Acetaminophen and Diclofenac in people with Low Back Pain, Mechanical, run by San Antonio Military Medical Center.

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

The randomized controlled study aims was to investigate the pain control of Battle Field Acupuncture as Primary or Adjunctive Treatment in Back Pain (Acute Musculoskeletal pain) in the (acute pain setting) Emergency Department vs stand of care pain medications. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Low Back Pain, Mechanical
What is being tested?
Battlefield Acupuncture, Acetaminophen and Diclofenac
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
No sites listed yet
Study dates
22 Feb 2016to 12 Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

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 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Individuals to be enrolled the study will be:
  • 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

Who cannot join

  • The individuals eligible for the study will be in good health, as defined by the World Health Organization (WHO, 2006). "Health is a state of complete physical, mental, and social wellbeing and not merely the absence of disease or infirmity" (WHO, 2006). Specific exclusion criteria will include,
  • Participants presenting with open wound injuries
  • 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)
Show all 12Show fewer
  • 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.

About this study

The randomized controlled study aims was to investigate the pain control of Battle Field Acupuncture as Primary or Adjunctive Treatment in Back Pain (Acute Musculoskeletal pain) in the (acute pain setting) Emergency Department vs stand of care pain medications.

Read the detailed description

Purpose: To evaluate the effectiveness of Battlefield Acupuncture versus standard care (medicinal therapy) in an Emergency Room setting for acute/subacute back pain using the Visual Analog Scale (VAS) and Numeric Rating Scale (NRS) to determine changes in pain levels. Secondary outcomes will include performance using the back pain functional scale (BPFS), satisfaction of treatment, and the need for further pain medication after discharge from the emergency department.

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.

Being tested
Battlefield Acupuncture, Acetaminophen, Diclofenac, Diazepam, Hydrocodone
Keywords
Battlefield Acupuncture, Auricular Acupuncture, Complementary Alternative Medicine, Military, Service Members, Emergency Medicine, Back Pain, Acute Back Pain, Chronic Back Pain, Alternative Medicine,
Medical subject headings
Low Back Pain, Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Battlefield AcupunctureDevice

    1-10 needles inserted in systematic nature as described by Battlefield acupuncture protocol.

  • AcetaminophenDrug

    Also called Tylenol

    Acetaminophen 500mg-1000mg,

  • DiclofenacDrug

    Also called Voltaren

    Diclofenac 50mg-75 mg orally

  • DiazepamDrug

    Also called Valium

    Diazepam 5mg-10 mg intravenous or oral

  • HydrocodoneDrug

    Also called Norco

    Hydrocodone 5mg/325mg-10mg/650mg mg

  • KetorolacDrug

    Also called Toradol

    oral, or intramuscular Ketorolac 30mg-60 mg

Study groups in NCT03996564
Study groupRoleWhat they receive
Acupuncture GroupActive comparatorBattlefield 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.
Receives: Device: Battlefield Acupuncture
Standard Care GroupActive comparatorParticipants 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.
Receives: Drug: Acetaminophen; Drug: Diclofenac; Drug: Diazepam; Drug: Hydrocodone; Drug: Ketorolac

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. time-response of BFA, and the association with pain level using the Visual Analog scale (0-10 mm) scoring as well as the Numeric Rating Scale (0-10) scoring

    determine if there is any significant change in pain in the BFA treatment group at specific time points using the Visual Analog scale (0-10 mm) scoring as well as the Numeric Rating Scale (0-10) scoring

    Measured: before treatment, 30-40 minutes post-treatment, and 48 to 72 hours post-treatment

  2. Evaluate the change of pain on Visual Analog scale (0-10mm) scoring with BFA administered in the emergency department for persons presenting with non-pathologic back pain.

    Using the Visual Analog scale which is a 10mm line, the patient will place a mark on the graph which will be measured to determine if there is any significant difference between the BFA treatment group pain at specific timepoints using the VAS. The lower the score determined on the scale corresponds to a lower pain level for the patient and a higher score corresponds to a higher pain level.

    Measured: baseline and at 30-40 minutes post treatment

  3. Evaluate the change of pain on Numeric Rating Scale (0-10) scoring with BFA administered in the emergency department for persons presenting with non-pathologic back pain.

    The Numeric Rating scale which is a scale that is verbally asked to determine the patients pain response on a scale from 0 to 10 determine if there is any significant difference between the BFA treatment group pain at specific timepoints using the NRS. The lower the score determined on the scale corresponds to a lower pain level for the patient and a higher score corresponds to a higher pain level.

    Measured: baseline, 30-40 minutes, and 48-72 hours

Secondary outcomes (4)

  1. time-response

    Time response will determine change in pain associated with the Numeric Rating scale (measured 0-10, 0 being least, 10 being most) from baseline, at 30-40 minutes after treatment, and between 48-72 hours after discharge.

    Measured: 30-40 minutes after treatment, and between 48-72 hours after discharge

  2. Examine the functionality score changes at 3 time points using the Back Pain Functional Scale

    Stratford et al developed the Back Pain Function Scale (BPFS) (scored 0-60 with higher scores showing no difficulty and lower scores showing patient is unable to perform activity) to evaluation functional ability in patients with back pain. The authors are from McMaster University Appalachian Physical Therapy (Georgia) and Virginia Commonwealth University.

    Measured: baseline, at the time the patient is to be discharged from the Emergency Room (0-3 hrs post baseline assessment), and 48-72 hours after discharge

  3. Explore participant satisfaction of pain control in the BFA treatment group: 1 question

    1 question regarding overall pain control satisfaction, and 2 specifically addressing those in the acupuncture group

    Measured: At discharge from the Emergency Room (0-3 hours post baseline assessment) and between 48-72 hours after discharge

  4. The need for any additional pain medication outside of the treatment protocol

    Number of patients that required any additional pain medications either in the Emergency Room or at home to include over the counter or prescription

    Measured: recorded at the 48-72 hours from discharge for the follow up interview

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2019
  2. Study start22 Feb 2016
  3. Primary completion12 Dec 2016
  4. Study completion12 Dec 2016

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
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03996564
Sponsor's protocol ID
C.2016.017d
Status last verified
Jun 2019
First submitted
7 Sep 2018
Last updated
26 Jun 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Buckenmaier CC 3rd, Rupprecht C, McKnight G, McMillan B, White RL, Gallagher RM, Polomano R. Pain following battlefield injury and evacuation: a survey of 110 casualties from the wars in Iraq and Afghanistan. Pain Med. 2009 Nov;10(8):1487-96. doi: 10.1111/j.1526-4637.2009.00731.x. Epub 2009 Oct 14.

    PubMed 19843233

  • Butler FK Jr, Kotwal RS, Buckenmaier CC 3rd, Edgar EP, O'Connor KC, Montgomery HR, Shackelford SA, Gandy JV, Wedmore I, Timby JW, Gross K, Bailey JA. A Triple-Option Analgesia Plan for Tactical Combat Casualty Care: TCCC Guidelines Change 13-04. J Spec Oper Med. 2014 Spring;14(1):13-25. doi: 10.55460/CBRW-A2G1.

    PubMed 24604434

  • Burns, S., et al. (2013). "Moving Acupuncture to the Frontline of Military Medical Care: A Feasibility Study." Medical Acupuncture 25(1): 49-54.

  • Chang BH, Sommers E. Acupuncture and relaxation response for craving and anxiety reduction among military veterans in recovery from substance use disorder. Am J Addict. 2014 Mar-Apr;23(2):129-36. doi: 10.1111/j.1521-0391.2013.12079.x. Epub 2013 Aug 30.

    PubMed 25187049

  • Cohen SP, Griffith S, Larkin TM, Villena F, Larkin R. Presentation, diagnoses, mechanisms of injury, and treatment of soldiers injured in Operation Iraqi Freedom: an epidemiological study conducted at two military pain management centers. Anesth Analg. 2005 Oct;101(4):1098-1103. doi: 10.1213/01.ane.0000169332.45209.cf.

    PubMed 16192528

  • Corwell BN. The emergency department evaluation, management, and treatment of back pain. Emerg Med Clin North Am. 2010 Nov;28(4):811-39. doi: 10.1016/j.emc.2010.06.001. Epub 2010 Aug 4.

    PubMed 20971393

  • Delgado R, York A, Lee C, Crawford C, Buckenmaier C 3rd, Schoomaker E, Crawford P; Active Self-Care Therapies for Pain (PACT) Working Group. Assessing the quality, efficacy, and effectiveness of the current evidence base of active self-care complementary and integrative medicine therapies for the management of chronic pain: a rapid evidence assessment of the literature. Pain Med. 2014 Apr;15 Suppl 1:S9-20. doi: 10.1111/pme.12412.

    PubMed 24734865

  • Gawande A. Casualties of war--military care for the wounded from Iraq and Afghanistan. N Engl J Med. 2004 Dec 9;351(24):2471-5. doi: 10.1056/NEJMp048317. No abstract available.

    PubMed 15590948

  • Goertz CM, Niemtzow R, Burns SM, Fritts MJ, Crawford CC, Jonas WB. Auricular acupuncture in the treatment of acute pain syndromes: A pilot study. Mil Med. 2006 Oct;171(10):1010-4. doi: 10.7205/milmed.171.10.1010.

    PubMed 17076456

  • Gondusky JS, Reiter MP. Protecting military convoys in Iraq: an examination of battle injuries sustained by a mechanized battalion during Operation Iraqi Freedom II. Mil Med. 2005 Jun;170(6):546-9. doi: 10.7205/milmed.170.6.546.

    PubMed 16001610

  • Jones D, Shug S. Opioids in chronic pain of non-malignant origin: an interim consensus. N Z Med J. 1995 Nov 24;108(1012):492. No abstract available.

    PubMed 8538981

  • Kim KH, Lee BR, Ryu JH, Choi TY, Yang GY. The role of acupuncture in emergency department settings: a systematic review. Complement Ther Med. 2013 Feb;21(1):65-72. doi: 10.1016/j.ctim.2012.12.004. Epub 2012 Dec 29.

    PubMed 23374207

  • Lande RG. Sleep problems, posttraumatic stress, and mood disorders among active-duty service members. J Am Osteopath Assoc. 2014 Feb;114(2):83-9. doi: 10.7556/jaoa.2014.021.

    PubMed 24481800

  • Lazar SG. The mental health needs of military service members and veterans. Psychodyn Psychiatry. 2014 Sep;42(3):459-78. doi: 10.1521/pdps.2014.42.3.459.

    PubMed 25211433

  • Lew HL, Otis JD, Tun C, Kerns RD, Clark ME, Cifu DX. Prevalence of chronic pain, posttraumatic stress disorder, and persistent postconcussive symptoms in OIF/OEF veterans: polytrauma clinical triad. J Rehabil Res Dev. 2009;46(6):697-702. doi: 10.1682/jrrd.2009.01.0006.

    PubMed 20104399

Questions about this trial

What is this clinical trial studying?

A study testing Battlefield Acupuncture, Acetaminophen and Diclofenac in people with Low Back Pain, Mechanical, run by San Antonio Military Medical Center.

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 7 inclusion and 12 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 26 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

time-response of BFA, and the association with pain level using the Visual Analog scale (0-10 mm) scoring as well as the Numeric Rating Scale (0-10) scoring (time frame: before treatment, 30-40 minutes post-treatment, and 48 to 72 hours post-treatment). The study lists 3 primary outcomes in all. 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 NCT03996564, which also lists 27 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 26 Jun 2019.

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