Assessment of chiropractic treatment for active duty, U.S. military personnel with low back pain: study protocol for a randomized controlled trial

Christine M Goertz, Cynthia R Long, Robert D Vining, Katherine A Pohlman, Bridget Kane, Lance Corber, Joan Walter, Ian Coulter, Christine M Goertz, Cynthia R Long, Robert D Vining, Katherine A Pohlman, Bridget Kane, Lance Corber, Joan Walter, Ian Coulter

Abstract

Background: Low back pain is highly prevalent and one of the most common causes of disability in U.S. armed forces personnel. Currently, no single therapeutic method has been established as a gold standard treatment for this increasingly prevalent condition. One commonly used treatment, which has demonstrated consistent positive outcomes in terms of pain and function within a civilian population is spinal manipulative therapy provided by doctors of chiropractic. Chiropractic care, delivered within a multidisciplinary framework in military healthcare settings, has the potential to help improve clinical outcomes for military personnel with low back pain. However, its effectiveness in a military setting has not been well established. The primary objective of this study is to evaluate changes in pain and disability in active duty service members with low back pain who are allocated to receive usual medical care plus chiropractic care versus treatment with usual medical care alone.

Methods/design: This pragmatic comparative effectiveness trial will enroll 750 active duty service members with low back pain at three military treatment facilities within the United States (250 from each site) who will be allocated to receive usual medical care plus chiropractic care or usual medical care alone for 6 weeks. Primary outcomes will include the numerical rating scale for pain intensity and the Roland-Morris Disability Questionnaire at week 6. Patient reported outcomes of pain, disability, bothersomeness, and back pain function will be collected at 2, 4, 6, and 12 weeks from allocation.

Discussion: Because low back pain is one of the leading causes of disability among U.S. military personnel, it is important to find pragmatic and conservative treatments that will treat low back pain and preserve low back function so that military readiness is maintained. Thus, it is important to evaluate the effects of the addition of chiropractic care to usual medical care on low back pain and disability.

Trial registration: The trial discussed in this article was registered in ClinicalTrials.gov with the NCT01692275 Date of registration: 6 September 2012.

Figures

Fig. 1
Fig. 1
ACT 1 study flow chart

References

    1. Dagenais S, Caro J, Haldeman S. A systematic review of low back pain cost of illness studies in the United States and internationally. Spine J. 2008;8:8–20. doi: 10.1016/j.spinee.2007.10.005.
    1. Cohen SP, Nguyen C, Kapoor SG, Anderson-Barnes VC, Foster L, Shields C, et al. Back pain during war: an analysis of factors affecting outcome. Arch Intern Med. 2009;169:1916–23. doi: 10.1001/archinternmed.2009.380.
    1. Medical Surveillance Monthly Report (MSMR). Armed Forces Health Surveillance Center. Absolute and relative morbidity burdens attributable to various illness and injuries, U.S. Armed Forces. 14, 18–23. 2007.
    1. Low back pain, active component, U.S. Armed Forces, 2000–2009. 07, 2–13. 2010.
    1. Knox J, Orchowski J, Scher DL, Owens BD, Burks R, Belmont PJ. The incidence of low back pain in active duty United States military service members. Spine. 2011;36:1492–500. doi: 10.1097/BRS.0b013e3181f40ddd.
    1. Cohen SP, Gallagher RM, Davis SA, Griffith SR, Carragee EJ. Spine-area pain in military personnel: a review of epidemiology, etiology, diagnosis, and treatment. Spine J. 2012;12:833–42. doi: 10.1016/j.spinee.2011.10.010.
    1. Lincoln AE, Smith GS, Amoroso PJ, Bell NS. The natural history and risk factors of musculoskeletal conditions resulting in disability among US Army personnel. Work. 2002;18:99–113.
    1. Aldington DJ. Back pain: the silent military threat: comment on “back pain during war”. Arch Intern Med. 2009;169:1923–4. doi: 10.1001/archinternmed.2009.385.
    1. Jones BH, Canham-Chervak M, Canada S, Mitchener TA, Moore S. Medical surveillance of injuries in the U.S. military. Descriptive epidemiology and recommendations for improvement. Am J Prev Med. 2010;38:S42–60. doi: 10.1016/j.amepre.2009.10.014.
    1. National Board of Chiropractic Examiners. Practice analysis of chiropractic 2015. 2015. .
    1. Murphy DR, Justice BD, Paskowski IC, Perle SM, Schneider MJ. The establishment of a primary spine care practitioner and its benefits to health care reform in the United States. Chiropr Man Therap. 2011;19:17. doi: 10.1186/2045-709X-19-17.
    1. Barnes PM, Powell-Griner E, McFann K, Nahin RL. Complementary and alternative medicine use among adults: United States. Adv Data. 2004;2002:1–19.
    1. Barnes PM, Bloom B, Nahin RL. Complementary and alternative medicine use among adults and children: United States. Natl Health Stat Report. 2008;2007:1–23.
    1. Carey TS, Garrett J, Jackman A, McLaughlin C, Fryer J, Smucker DR. The outcomes and costs of care for acute low back pain among patients seen by primary care practitioners, chiropractors, and orthopedic surgeons. The North Carolina Back Pain Project. N Engl J Med. 1995;333:913–7. doi: 10.1056/NEJM199510053331406.
    1. Cherkin DC, MacCornack FA. Patient evaluations of low back pain care from family physicians and chiropractors. West J Med. 1989;150:351–5.
    1. Weigel PA, Hockenberry JM, Wolinsky FD. Chiropractic use in the medicare population: prevalence, patterns, and associations with 1-year changes in health and satisfaction with care. J Manipulative Physiol Ther. 2014;37:542–51. doi: 10.1016/j.jmpt.2014.08.003.
    1. Leininger BD, Evans R, Bronfort G. Exploring patient satisfaction: a secondary analysis of a randomized clinical trial of spinal manipulation, home exercise, and medication for acute and subacute neck pain. J Manipulative Physiol Ther. 2014;37:593–601. doi: 10.1016/j.jmpt.2014.08.005.
    1. Bronfort G, Haas M, Evans RL, Bouter LM. Efficacy of spinal manipulation and mobilization for low back pain and neck pain: a systematic review and best evidence synthesis. Spine J. 2004;4:335–56. doi: 10.1016/j.spinee.2003.06.002.
    1. Rubinstein SM, Terwee CB, Assendelft WJ, de Boer MR, van Tulder MW. Spinal manipulative therapy for acute low back pain: an update of the cochrane review. Spine. 2013;38:E158–77. doi: 10.1097/BRS.0b013e31827dd89d.
    1. Goertz CM, Pohlman KA, Vining RV, Brantingham JW, Long CR. Patient-centered outcomes of high-velocity, low-amplitude spinal manipulation for low back pain: a systematic review. J Electromyogr Kinesiol. 2012;22(5):670–91. doi: 10.1016/j.jelekin.2012.03.006.
    1. Bishop PB, Quon JA, Fisher CG, Dvorak MF. The Chiropractic Hospital-based Interventions Research Outcomes (CHIRO) study: a randomized controlled trial on the effectiveness of clinical practice guidelines in the medical and chiropractic management of patients with acute mechanical low back pain. Spine J. 2010;10:1055–64. doi: 10.1016/j.spinee.2010.08.019.
    1. Lin CW, Haas M, Maher CG, Machado LA, van Tulder MW. Cost-effectiveness of guideline-endorsed treatments for low back pain: a systematic review. Eur Spine J. 2011;20:1024–38. doi: 10.1007/s00586-010-1676-3.
    1. Chou R, Qaseem A, Snow V, Casey D, Cross JT, Jr, Shekelle P, et al. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med. 2007;147:478–91. doi: 10.7326/0003-4819-147-7-200710020-00006.
    1. Koes BW, van Tulder MW, Ostelo R, Kim BA, Waddell G. Clinical guidelines for the management of low back pain in primary care: an international comparison. Spine. 2001;26:2504–13. doi: 10.1097/00007632-200111150-00022.
    1. Lisi AJ, Goertz C, Lawrence DJ, Satyanarayana P. Characteristics of Veterans Health Administration chiropractors and chiropractic clinics. J Rehabil Res Dev. 2009;46:997–1002. doi: 10.1682/JRRD.2009.01.0002.
    1. Green BN, Johnson CD, Lisi AJ, Tucker J. Chiropractic practice in military and veterans health care: the state of the literature. J Can Chiropr Assoc. 2009;53:194–204.
    1. Tricare. 2015. Accessed 11 Aug 2015.
    1. Goertz CM, Long CR, Hondras MA, Petri R, Delgado R, Lawrence DJ, et al. Adding chiropractic manipulative therapy to standard medical care for patients with acute low back pain: results of a pragmatic randomized comparative effectiveness study. Spine. 2013;38:627–34. doi: 10.1097/BRS.0b013e31827733e7.
    1. Macpherson H. Pragmatic clinical trials. Complement Ther Med. 2004;12:136–40. doi: 10.1016/j.ctim.2004.07.043.
    1. Godwin M, Ruhland L, Casson I, MacDonald S, Delva D, Birtwhistle R, et al. Pragmatic controlled clinical trials in primary care: the struggle between external and internal validity. BMC Med Res Methodol. 2003;3:28. doi: 10.1186/1471-2288-3-28.
    1. Luce BR, Kramer JM, Goodman SN, Connor JT, Tunis S, Whicher D, et al. Rethinking randomized clinical trials for comparative effectiveness research: the need for transformational change. Ann Intern Med. 2009;151:206–9. doi: 10.7326/0003-4819-151-3-200908040-00126.
    1. Facts - Walter Reed National Military Medical Center. . Accessed 18 Jun 2015.
    1. An American Physical Therapy Association White Paper. 2009. American Physical Therapy Association.
    1. Childs JD, Piva SR, Fritz JM. Responsiveness of the numeric pain rating scale in patients with low back pain. Spine. 2005;30:1331–4. doi: 10.1097/01.brs.0000164099.92112.29.
    1. van der Roer N, Ostelo RW, Bekkering GE, van Tulder MW, de Vet HC. Minimal clinically important change for pain intensity, functional status, and general health status in patients with nonspecific low back pain. Spine. 2006;31:578–82. doi: 10.1097/01.brs.0000201293.57439.47.
    1. Jensen MP, Karoly P. Self-report scales and procedures for assessing pain in adults. In: Turk DC, Melzack R, editors. Handbook of pain assessment. 2. New York: Guilford Press; 2001. pp. 15–34.
    1. Deyo RA, Battie M, Beurskens AJ, Bombardier C, Croft P, Koes B, et al. Outcome measures for low back pain research. A proposal for standardized use. Spine. 1998;23:2003–13. doi: 10.1097/00007632-199809150-00018.
    1. Roland M, Fairbank J. The Roland-Morris Disability Questionnaire and the Oswestry Disability Questionnaire. Spine. 2000;25:3115–24. doi: 10.1097/00007632-200012150-00006.
    1. Riddle DL, Stratford PW, Binkley JM. Sensitivity to change of the Roland-Morris Back Pain Questionnaire: part 2. Phys Ther. 1998;78:1197–207.
    1. Deyo RA, Cherkin D, Conrad D. The Back Pain Outcome Assessment Team. Health Serv Res. 1990;25:733–7.
    1. Stratford PW, Binkley JM, Riddle DL. Development and initial validation of the back pain functional scale. Spine. 2000;25:2095–102. doi: 10.1097/00007632-200008150-00015.
    1. Patrick DL, Deyo RA, Atlas SJ, Singer DE, Chapin A, Keller RB. Assessing health-related quality of life in patients with sciatica. Spine. 1995;20:1899–908. doi: 10.1097/00007632-199509000-00011.
    1. Dunn KM, Croft PR. Classification of low back pain in primary care: using “bothersomeness” to identify the most severe cases. Spine. 2005;30:1887–92. doi: 10.1097/01.brs.0000173900.46863.02.
    1. Universal health outcome measures for older persons with multiple chronic conditions. J Am Geriatr Soc. 2012, 60: 2333–2341.
    1. Koes BW, Bouter LM, van Mameren H, Essers AH, Verstegen GM, Hofhuizen DM, et al. A blinded randomized clinical trial of manual therapy and physiotherapy for chronic back and neck complaints: physical outcome measures. J Manipulative Physiol Ther. 1992;15:16–23.
    1. Deyo RA, Walsh NE, Martin DC, Schoenfeld LS, Ramamurthy S. A controlled trial of transcutaneous electrical nerve stimulation (TENS) and exercise for chronic low back pain. N Engl J Med. 1990;322:1627–34. doi: 10.1056/NEJM199006073222303.
    1. Hansen FR, Bendix T, Skov P, Jensen CV, Kristensen JH, Krohn L, et al. Intensive, dynamic back-muscle exercises, conventional physiotherapy, or placebo-control treatment of low-back pain. A randomized, observer-blind trial. Spine. 1993;18:98–108. doi: 10.1097/00007632-199301000-00015.
    1. Kalauokalani D, Cherkin DC, Sherman KJ, Koepsell TD, Deyo RA. Lessons from a trial of acupuncture and massage for low back pain: patient expectations and treatment effects. Spine (Phila Pa 1976) 2001;26:1418–24. doi: 10.1097/00007632-200107010-00005.
    1. Ostelo RW, Deyo RA, Stratford P, Waddell G, Croft P, Von KM, et al. Interpreting change scores for pain and functional status in low back pain: towards international consensus regarding minimal important change. Spine. 2008;33:90–4. doi: 10.1097/BRS.0b013e31815e3a10.
    1. Deyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E, et al. Report of the NIH task force on research standards for chronic low back pain. Spine. 2014;39:1128–43. doi: 10.1097/BRS.0000000000000434.
    1. Carpenter J, Kenward MG. Missing data in randomised controlled trials - a practical guide. Birmingham: National Institute for Health Research; 2008. Accessed 24 Jul 2013.
    1. National Institutes of Health. Guidance on reporting adverse events to institutional review boards for NIH-supported multicenter clinical trials. Accessed 15 Oct 2015.

Source: PubMed

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

3
Suscribir