drugset / Trial / NCT03996564
Battlefield Acupuncture for Acute/Subacute Back Pain in the Emergency Department
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2016-02-22
- Primary completion
- 2016-12-12
- Completion
- 2016-12-12
Publications
- Background 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.
- Background 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.
- Background Burns, S., et al. (2013). "Moving Acupuncture to the Frontline of Military Medical Care: A Feasibility Study." Medical Acupuncture 25(1): 49-54.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Acetaminophen | Small molecule | 500 mg | Oral |
| Comparator | Acetaminophen | Small molecule | 1000 mg | Oral |
| Comparator | Diazepam | Small molecule | 5 mg | — |
| Comparator | Diazepam | Small molecule | 10 mg | — |
| Comparator | Diclofenac | Other / unclassified | 50 mg | Oral |
| Comparator | Diclofenac | Other / unclassified | 75 mg | Oral |
| Comparator | Hydrocodone | Unknown | 5 mg | Oral |
| Comparator | Hydrocodone | Unknown | 10 mg | Oral |
| Comparator | Ketorolac | Other / unclassified | 30 mg | Oral |
| Comparator | Ketorolac | Other / unclassified | 60 mg | Oral |
Indications
No indication recorded.