Clinical trial NCT03996564: Battlefield Acupuncture for Acute/Subacute Back Pain in the Emergency Department
Official title: Battlefield Acupuncture for Acute/Subacute Back Pain in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain, Mechanical
Keywords: Battlefield Acupuncture
Auricular Acupuncture
Complementary Alternative Medicine
Military, Service Members
Emergency Medicine
Back Pain
Acute Back Pain
Chronic Back Pain
Alternative Medicine,
Lead sponsor: San Antonio Military Medical Center
Sponsor class: FED
First posted: 2019-06-25
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)
  * 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.

Primary outcomes:
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
timeFrame: before treatment, 30-40 minutes post-treatment, and 48 to 72 hours post-treatment
measure: 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.
timeFrame: baseline and at 30-40 minutes post treatment
measure: 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.
timeFrame: baseline, 30-40 minutes, and 48-72 hours
Secondary outcomes:
measure: time-response
timeFrame: 30-40 minutes after treatment, and between 48-72 hours after discharge
measure: Examine the functionality score changes at 3 time points using the Back Pain Functional Scale
timeFrame: 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
measure: Explore participant satisfaction of pain control in the BFA treatment group: 1 question
timeFrame: At discharge from the Emergency Room (0-3 hours post baseline assessment) and between 48-72 hours after discharge
measure: The need for any additional pain medication outside of the treatment protocol
timeFrame: recorded at the 48-72 hours from discharge for the follow up interview
Other outcomes:
Locations:
Study officials:
affiliation: Program Director
name: Timothy Bonjour, DSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Burns, S., et al. (2013). "Moving Acupuncture to the Frontline of Military Medical Care: A Feasibility Study." Medical Acupuncture 25(1): 49-54.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Outcalt SD, Ang DC, Wu J, Sargent C, Yu Z, Bair MJ. Pain experience of Iraq and Afghanistan Veterans with comorbid chronic pain and posttraumatic stress. J Rehabil Res Dev. 2014;51(4):559-70. doi: 10.1682/JRRD.2013.06.0134.
citation: Patel TH, Wenner KA, Price SA, Weber MA, Leveridge A, McAtee SJ. A U.S. Army Forward Surgical Team's experience in Operation Iraqi Freedom. J Trauma. 2004 Aug;57(2):201-7. doi: 10.1097/01.ta.0000133638.30269.38.
citation: Pennick V, Liddle SD. Interventions for preventing and treating pelvic and back pain in pregnancy. Cochrane Database Syst Rev. 2013 Aug 1;(8):CD001139. doi: 10.1002/14651858.CD001139.pub3.
citation: Pilkington K, Kirkwood G, Rampes H, Cummings M, Richardson J. Acupuncture for anxiety and anxiety disorders--a systematic literature review. Acupunct Med. 2007 Jun;25(1-2):1-10. doi: 10.1136/aim.25.1-2.1.
citation: Schug SA, Zech D, Grond S, Jung H, Meuser T, Stobbe B. A long-term survey of morphine in cancer pain patients. J Pain Symptom Manage. 1992 Jul;7(5):259-66. doi: 10.1016/0885-3924(92)90059-q.
citation: Seal KH, Shi Y, Cohen G, Cohen BE, Maguen S, Krebs EE, Neylan TC. Association of mental health disorders with prescription opioids and high-risk opioid use in US veterans of Iraq and Afghanistan. JAMA. 2012 Mar 7;307(9):940-7. doi: 10.1001/jama.2012.234.
citation: Seal KH, Metzler TJ, Gima KS, Bertenthal D, Maguen S, Marmar CR. Trends and risk factors for mental health diagnoses among Iraq and Afghanistan veterans using Department of Veterans Affairs health care, 2002-2008. Am J Public Health. 2009 Sep;99(9):1651-8. doi: 10.2105/AJPH.2008.150284. Epub 2009 Jul 16.
citation: Sharpe Potter J, Bebarta VS, Marino EN, Ramos RG, Turner BJ. Pain management and opioid risk mitigation in the military. Mil Med. 2014 May;179(5):553-8. doi: 10.7205/MILMED-D-13-00109.
citation: Tan HJ, Lan Y, Wu FS, Zhang HD, Wu L, Wu X, Liang FR. [Auricular acupuncture for primary insomnia: a systematic review based on GRADE system]. Zhongguo Zhen Jiu. 2014 Jul;34(7):726-30. Chinese.
citation: Vas J, Aranda-Regules JM, Modesto M, Aguilar I, Baron-Crespo M, Ramos-Monserrat M, Quevedo-Carrasco M, Rivas-Ruiz F. Auricular acupuncture for primary care treatment of low back pain and posterior pelvic pain in pregnancy: study protocol for a multicentre randomised placebo-controlled trial. Trials. 2014 Jul 16;15:288. doi: 10.1186/1745-6215-15-288.
citation: Vas J, Aguilar I, Perea-Milla E, Mendez C. Effectiveness of acupuncture and related techniques in treating non-oncological pain in primary healthcare--an audit. Acupunct Med. 2007 Jun;25(1-2):41-6. doi: 10.1136/aim.25.1-2.41.
citation: Vickers AJ, Cronin AM, Maschino AC, Lewith G, MacPherson H, Foster NE, Sherman KJ, Witt CM, Linde K; Acupuncture Trialists' Collaboration. Acupuncture for chronic pain: individual patient data meta-analysis. Arch Intern Med. 2012 Oct 22;172(19):1444-53. doi: 10.1001/archinternmed.2012.3654.