Assessment of chiropractic care on strength, balance, and endurance in active-duty U.S. military personnel with low back pain: a protocol for a randomized controlled trial

Robert Vining, Amy Minkalis, Cynthia R Long, Lance Corber, Crystal Franklin, M Ram Gudavalli, Ting Xia, Christine M Goertz, Robert Vining, Amy Minkalis, Cynthia R Long, Lance Corber, Crystal Franklin, M Ram Gudavalli, Ting Xia, Christine M Goertz

Abstract

Background: Low back pain (LBP) is a common cause of disability among U.S. military personnel. Approximately 20% of all diagnoses resulting in disability discharges are linked to back-related conditions. Because LBP can negatively influence trunk muscle strength, balance, and endurance, the military readiness of active-duty military personnel with LBP is potentially compromised. Chiropractic care may facilitate the strengthening of trunk muscles, the alteration of sensory and motor signaling, and a reduction in pain sensitivity, which may contribute to improving strength, balance, and endurance for individuals with LBP. This trial will assess the effects of chiropractic care on strength, balance, and endurance for active-duty military personnel with LBP.

Methods/design: This randomized controlled trial will allocate 110 active-duty military service members aged 18-40 with non-surgical acute, subacute, or chronic LBP with pain severity of ≥2/10 within the past 24 h. All study procedures are conducted at a single military treatment facility within the continental United States. Participants are recruited through recruitment materials approved by the institutional review board, such as posters and flyers, as well as through provider referrals. Group assignment occurs through computer-generated random allocation to either the study intervention (chiropractic care) or the control group (waiting list) for a 4-week period. Chiropractic care consists primarily of spinal manipulation at a frequency and duration determined by a chiropractic practitioner. Strength, balance, and endurance outcomes are obtained at baseline and after 4 weeks. The primary outcome is a change between baseline and 4 weeks of peak isometric strength, which is measured by pulling on a bimanual handle in a semi-squat position. Secondary outcomes include balance time during a single-leg standing test and trunk muscle endurance with the Biering-Sorensen test. Patient-reported outcomes include pain severity, disability measured with the Roland Morris Disability Questionnaire, symptom bothersomeness, PROMIS-29, Fear Avoidance Beliefs Questionnaire, expectations of care, physical activity, and global improvement.

Discussion: This trial may help inform further research on biological mechanisms related to manual therapies employed by chiropractic practitioners.

Trial registration: ClinicalTrials.gov, NCT02670148 Registered on 1 February 2016.

Keywords: balance; chiropractic; endurance; low back pain; military; spinal manipulative therapy; strength.

Conflict of interest statement

Ethics approval and consent to participate

Ethics approval for this trial was granted by Palmer College of Chiropractic (2015G171), the RAND Corporation (2013–0159), and NHP (NHPC.2015.0003, IRB of record: Naval Medical Center Portsmouth, VA). The trial protocol was also approved by the Naval Medical Center Portsmouth Clinical Investigation Department and the U.S. Army Medical Research and Material Command Human Research Protection Office.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study flowchart
Fig. 2
Fig. 2
Schedule of events
Fig. 3
Fig. 3
Strength test. Isometric pulling in a semi-squat position with upright torso and eyes facing forward. Foot position is standardized within participants using platform markings (a). The bimanual handle (b) is attached to a force transducer. Pulling height is standardized using an adjustable post accommodating variable participant height (c)
Fig. 4
Fig. 4
Balance test. Test performed with eyes open and with eyes closed. Pressure sensitive pads (a) are connected to a computer timer. Lifting the heel (b) removes the pressure, which starts the timer. Touching any pad with either foot stops the timer and ends the test
Fig. 5
Fig. 5
Endurance (Biering-Sorensen) test. a Head, shoulders, and trunk extend over the edge of a table. The lower extremities are strapped to the table. b Timing begins when the participant lifts their arms off the support stool while maintaining a neutral trunk position. The test ends if pain or discomfort is experienced or after a maximum of 180 s.

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(1):8–20.
    1. Walker BF. The prevalence of low back pain: a systematic review of the literature from 1966 to 1998. J Spinal Disord. 2000;13(3):205–217.
    1. Nachemson AL, Jonsson E. Neck and Back Pain. Philadelphia: Lippincott Williams & Wilkins; 2000.
    1. Cohen SP, Nguyen C, Kapoor SG, Anderson-Barnes VC, Foster L, Shields C, McLean B, Wichman T, Plunkett A. Back pain during war: an analysis of factors affecting outcome. Arch Intern Med. 2009;169(20):1916–1923.
    1. Feuerstein M, Berkowitz SM, Peck CA., Jr Musculoskeletal-related disability in US Army personnel: prevalence, gender, and military occupational specialties. J Occup Environ Med. 1997;39(1):68–78.
    1. Aldington DJ. Back pain: the silent military threat: comment on "back pain during war". Arch Intern Med. 2009;169(20):1923–1924.
    1. Roy TC, Lopez HP, Piva SR. Loads worn by soldiers predict episodes of low back pain during deployment to Afghanistan. Spine. 2013;38(15):1310–1317.
    1. Oyarzo CA, Villagran CR, Silvestre RE, Carpintero P, Berral FJ. Postural control and low back pain in elite athletes comparison of static balance in elite athletes with and without low back pain. J Back Musculoskelet Rehabil. 2014;27(2):141–146.
    1. Hamberg-van Reenen HH, Ariens GA, Blatter BM, van Mechelen W, Bongers PM. A systematic review of the relation between physical capacity and future low back and neck/shoulder pain. Pain. 2007;130(1–2):93–107.
    1. Hodges PW, Coppieters MW, MacDonald D, Cholewicki J. New insight into motor adaptation to pain revealed by a combination of modelling and empirical approaches. Eur J Pain. 2013;17(8):1138–1146.
    1. Steele J, Bruce-Low S, Smith D. A reappraisal of the deconditioning hypothesis in low back pain: review of evidence from a triumvirate of research methods on specific lumbar extensor deconditioning. Curr Med Res Opin. 2014;30(5):865–911.
    1. van Dieen JH, Cholewicki J, Radebold A. Trunk muscle recruitment patterns in patients with low back pain enhance the stability of the lumbar spine. Spine. 2003;28(8):834–841.
    1. Lund JP, Donga R, Widmer CG, Stohler CS. The pain-adaptation model: a discussion of the relationship between chronic musculoskeletal pain and motor activity. Can J Physiol Pharmacol. 1991;69(5):683–694.
    1. Evans K, Refshauge KM, Adams R. Trunk muscle endurance tests: reliability, and gender differences in athletes. J Sci Med Sport. 2007;10(6):447–455.
    1. Ham YW, Kim DM, Baek JY, Lee DC, Sung PS. Kinematic analyses of trunk stability in one leg standing for individuals with recurrent low back pain. J Electromyogr Kinesiol. 2010;20(6):1134–1140.
    1. Lee DC, Ham YW, Sung PS. Effect of visual input on normalized standing stability in subjects with recurrent low back pain. Gait Posture. 2012;36(3):580–585.
    1. Beliveau PJH, Wong JJ, Sutton DA, Simon NB, Bussieres AE, Mior SA, French SD. The chiropractic profession: a scoping review of utilization rates, reasons for seeking care, patient profiles, and care provided. Chiropr Man Therap. 2017;25:35.
    1. Chou Roger, Deyo Richard, Friedly Janna, Skelly Andrea, Hashimoto Robin, Weimer Melissa, Fu Rochelle, Dana Tracy, Kraegel Paul, Griffin Jessica, Grusing Sara, Brodt Erika D. Nonpharmacologic Therapies for Low Back Pain: A Systematic Review for an American College of Physicians Clinical Practice Guideline. Annals of Internal Medicine. 2017;166(7):493.
    1. Qaseem Amir, Wilt Timothy J., McLean Robert M., Forciea Mary Ann. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Annals of Internal Medicine. 2017;166(7):514.
    1. Pickar JG. Neurophysiological effects of spinal manipulation. Spine J. 2002;2(5):357–371.
    1. Suter E, McMorland G, Herzog W, Bray R. Decrease in quadriceps inhibition after sacroiliac joint manipulation in patients with anterior knee pain. J Manip Physiol Ther. 1999;22(3):149–153.
    1. Suter E, McMorland G. Decrease in elbow flexor inhibition after cervical spine manipulation in patients with chronic neck pain. Clin Biomech (Bristol, Avon) 2002;17(7):541–544.
    1. Koppenhaver SL, Fritz JM, Hebert JJ, Kawchuk GN, Childs JD, Parent EC, Gill NW, Teyhen DS. Association between changes in abdominal and lumbar multifidus muscle thickness and clinical improvement after spinal manipulation. J Orthop Sports Phys Ther. 2011;41(6):389–399.
    1. Koppenhaver SL, Fritz JM, Hebert JJ, Kawchuk GN, Parent EC, Gill NW, Childs JD, Teyhen DS. Association between history and physical examination factors and change in lumbar multifidus muscle thickness after spinal manipulation in patients with low back pain. J Electromyogr Kinesiol. 2012;22(5):724–731.
    1. Ferreira ML, Ferreira PH, Hodges PW. Changes in postural activity of the trunk muscles following spinal manipulative therapy. Man Ther. 2007;12(3):240–248.
    1. Bialosky JE, George SZ, Horn ME, Price DD, Staud R, Robinson ME. Spinal Manipulative Therapy-Specific Changes in Pain Sensitivity in Individuals With Low Back Pain (NCT01168999) J Pain. 2014;15(2):136–148.
    1. Bialosky JE, George SZ, Bishop MD. How spinal manipulative therapy works: why ask why? J Orthop Sports Phys Ther. 2008;38(6):293–295.
    1. Bialosky JE, Bishop MD, Price DD, Robinson ME, George SZ. The mechanisms of manual therapy in the treatment of musculoskeletal pain: a comprehensive model. Man Ther. 2009;14(5):531–538.
    1. Vining RD, Salsbury SA, Pohlman KA. Eligibility determination for clinical trials: development of a case review process at a chiropractic research center. Trials. 2014;15:406.
    1. American Physical Therapy Association. Position on Thrust Joint Manipulation provided by Physical Therapists. Alexandria, VA: American Physical Therapy Association; 2009.
    1. Evans DW. Mechanisms and effects of spinal high-velocity, low-amplitude thrust manipulation: Previous theories. JMPT. 2002;25:251–262.
    1. Evans DW, Lucas N. What is 'manipulation'? A reappraisal. Man Ther. 2010;15(3):286–291.
    1. Evans DW. Why do spinal manipulation techniques take the form they do? Towards a general model of spinal manipulation. Man Ther. 2010;15(3):212–219.
    1. Cox JM. Low Back Pain: Mechanism, Diagnosis and Treatment, 7th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2011.
    1. Gudavalli MR, Cambron JA, McGregor M, Jedlicka J, Keenum M, Ghanayem AJ, Patwardhan AG. A randomized clinical trial and subgroup analysis to compare flexion-distraction with active exercise for chronic low back pain. Eur Spine J. 2006;15(7):1070–1082.
    1. Simmonds N, Miller P, Gemmell H. A theoretical framework for the role of fascia in manual therapy. J Bodyw Mov Ther. 2012;16(1):83–93.
    1. Cook G, Burton L, Hoogenboom BJ, Voight M. Functional movement screening: the use of fundamental movements as an assessment of function - part 1. Int J Sports Phys Ther. 2014;9(3):396–409.
    1. Cook G, Burton L, Hoogenboom BJ, Voight M. Functional movement screening: the use of fundamental movements as an assessment of function-part 2. Int J Sports Phys Ther. 2014;9(4):549–563.
    1. Myer GD, Kushner AM, Brent JL, Schoenfeld BJ, Hugentobler J, Lloyd RS, Vermeil A, Chu DA, Harbin J, McGill SM. The back squat: A proposed assessment of functional deficits and technical factors that limit performance. Strength Cond J. 2014;36(6):4–27.
    1. da Silva RAJ, Arsenault AB, Gravel D, LaRiviere C, de Oliveira E., Jr Back muscle strength and fatigue in healthy and chronic low back pain subjects: a comparative study of 3 assessment protocols. Arch Phys Med Rehabil. 2005;86(4):722–729.
    1. Johnson BL, Nelson JK. Practical measurements for evaluation in physical education. 4. Minneapolis: Burgess; 1979.
    1. Gruther W, Wick F, Paul B, Leitner C, Posch M, Matzner M, Crevenna R, Ebenbichler G. Diagnostic accuracy and reliability of muscle strength and endurance measurements in patients with chronic low back pain. J Rehabil Med. 2009;41(8):613–619.
    1. Moradi B, Benedetti J, Zahlten-Hinguranage A, Schiltenwolf M, Neubauer E. The value of physical performance tests for predicting therapy outcome in patients with subacute low back pain: a prospective cohort study. Eur Spine J. 2009;18(7):1041–1049.
    1. Von KM, Jensen MP, Karoly P. Assessing global pain severity by self-report in clinical and health services research. Spine. 2000;25(24):3140–3151.
    1. Stratford PW, Binkley JM, Riddle DL. Development and initial validation of the back pain functional scale. Spine. 2000;25(16):2095–2102.
    1. Riddle DL, Stratford PW, Binkley JM. Sensitivity to change of the Roland-Morris Back Pain Questionnaire: part 2. Phys Ther. 1998;78(11):1197–1207.
    1. Dunn KM, Croft PR. Classification of low back pain in primary care: using "bothersomeness" to identify the most severe cases. Spine. 2005;30(16):1887–1892.
    1. Deyo RA, Battie M, Beurskens AJ, Bombardier C, Croft P, Koes B, Malmivaara A, Roland M, Von KM, Waddell G. Outcome measures for low back pain research. A proposal for standardized use. Spine. 1998;23(18):2003–2013.
    1. Licciardone JC, Kishino N, Worzer W, Hartzell M, Gatchel R. An overview of the patient-reported outcomes measurement information system (PROMIS) for assessing chronic low back pain patients. J Appl Biobehav Res. 2017;22(e12057):1–22.
    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. 2001;26(13):1418–1424.
    1. Kamper SJ, Ostelo RW, Knol DL, Maher CG, de Vet HC, Hancock MJ. Global Perceived Effect scales provided reliable assessments of health transition in people with musculoskeletal disorders, but ratings are strongly influenced by current status. J Clin Epidemiol. 2010;63(7):760–766.
    1. George SZ, Fritz JM, Childs JD. Investigation of elevated fear-avoidance beliefs for patients with low back pain: a secondary analysis involving patients enrolled in physical therapy clinical trials. J Orthop Sports Phys Ther. 2008;38(2):50–58.
    1. George SZ, Wittmer VT, Fillingim RB, Robinson ME. Fear-avoidance beliefs and temporal summation of evoked thermal pain influence self-report of disability in patients with chronic low back pain. J Occup Rehabil. 2006;16(1):95–108.
    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(17):1899–1908.
    1. Schulz KF, Altman DG, Moher D. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Trials. 2010;11:32.
    1. Goertz C, Long CR, Vining R, Pohlman K, Walter J, Coulter I. Effect of usual medical care plus chiropractic care vs usual medical care alone on pain and disability among US service members with low back pain: A comparative effectiveness trial. JAMA Netw Open. 2018;1(1):1–15.
    1. National Institutes of Health. Guidance on reporting adverse events to institutional review boards for NIH-supported multicenter clinical trials. 6-11-1999. National Institutes of Health. 3-23-2018.

Source: PubMed

3
Abonneren