Conservative care with or without manipulative therapy in the management of back and neck pain in Danish children aged 9-15. Study protocol for a randomized controlled trial

Kristina Boe Dissing, Jan Hartvigsen, Niels Wedderkopp, Lise Hestbæk, Kristina Boe Dissing, Jan Hartvigsen, Niels Wedderkopp, Lise Hestbæk

Abstract

Background: Complaints in the musculoskeletal system often start early in life and back and neck pain in children are well-established predictors for similar problems in adulthood. Despite lack of evidence of effectiveness, manipulative therapy is one of the most commonly used treatment modalities for back and neck pain in children. The primary objective of this study is to evaluate the effectiveness of manipulative therapy when added to an approach consisting of manual soft tissue treatment, exercises and advice as needed, in children aged 9-15 complaining of back and neck pain.

Method: The project is nested in the Childhood Health, Activity and Motor Performance School Study, which includes around 1200 children aged 9-15, who were all invited to participate in this randomized controlled trial in case they experienced back and/or neck pain during the two year inclusion period. Parents received text messages (SMS) on a weekly basis inquiring about the child's musculoskeletal pain. If pain was reported, the child was evaluated for inclusion into the trial and, if eligible, randomized into one of two intervention groups:Pragmatic advice, manual soft tissue treatment and exercisesThe above plus manipulative therapy By the end of data collection 237 children were included in the study. The primary outcome measure is number of recurrences of back and neck pain during the follow-up period (3-27 months). Secondary outcome measures are average duration of complaint time for each episode, total duration of complaint time, global perceived effect after two weeks, and change in pain intensity after 2 weeks. Baseline information includes quality of life, expectations to treatment, expectations to future course, age, gender, social class and physical education at school.

Discussion: For most common non-traumatic musculoskeletal complaints no standardized and evidence based treatment strategy exists. We want to evaluate the effectiveness of manipulative therapy in addition to an approach consisting of manual soft tissue treatment, exercises and advice as needed, in children aged 9-15 complaining of back and neck pain. To our knowledge this is the first large scale randomized controlled trial investigating the effectiveness of commonly used treatments for back and neck pain in children.

Trial registration: ClinicalTrials NCT01504698.

Keywords: Adolescents; Back pain; Children; Manipulative therapy; Neck pain; Randomized controlled trial; Spinal pain.

Figures

Fig. 1
Fig. 1
Flowchart CHAMPS/RCT
Fig. 2
Fig. 2
Flowchart RCT

References

    1. Jeffries LJ, Milanese SF, Grimmer-Somers KA. Epidemiology of adolescent spinal pain: a systematic overview of the research literature. Spine (Phila Pa 1976) 2007;32(23):2630–7. doi: 10.1097/BRS.0b013e318158d70b.
    1. Jones GT, Macfarlane GJ. Predicting persistent low back pain in schoolchildren: a prospective cohort study. Arthritis Rheum. 2009;61(10):1359–66. doi: 10.1002/art.24696.
    1. Calvo-Munoz I, Gomez-Conesa A, Sanchez-Meca J. Prevalence of low back pain in children and adolescents: a meta-analysis. BMC Pediatr. 2013;13:14. doi: 10.1186/1471-2431-13-14.
    1. Hulsegge G, van Oostrom SH, Picavet HS, Twisk JW, Postma DS, Kerkhof M, et al. Musculoskeletal complaints among 11-year-old children and associated factors: the PIAMA birth cohort study. Am J Epidemiol. 2011;174(8):877–84.
    1. Hestbaek L, Leboeuf-Yde C, Kyvik KO, Manniche C. The course of low back pain from adolescence to adulthood: eight-year follow-up of 9600 twins. Spine (Phila Pa 1976). 2006;31(4):468–72.
    1. Kjaer P, Wedderkopp N, Korsholm L, Leboeuf-Yde C. Prevalence and tracking of back pain from childhood to adolescence. BMC Musculoskelet Disord. 2011;12:98.
    1. Brattberg G. Do pain problems in young school children persist into early adulthood? A 13-year follow-up. Eur J Pain. 2004;8(3):187–99. doi: 10.1016/j.ejpain.2003.08.001.
    1. Dunn KM, Hestbaek L, Cassidy JD. Low back pain across the life course. Best Pract Res Clin Rheumatol. 2013;27(5):591–600. doi: 10.1016/j.berh.2013.09.007.
    1. Haraldstad K, Sorum R, Eide H, Natvig GK, Helseth S. Pain in children and adolescents: prevalence, impact on daily life, and parents' perception, a school survey. Scand J Caring Sci. 2011;25(1):27–36.
    1. Hestbaek L, Jorgensen A, Hartvigsen J. A description of children and adolescents in Danish chiropractic practice: results from a nationwide survey. J Manipulative Physiol Ther. 2009;32(8):607–15. doi: 10.1016/j.jmpt.2009.08.024.
    1. Klakk H, Andersen LB, Heidemann M, Moller NC, Wedderkopp N. Six physical education lessons a week can reduce cardiovascular risk in school children aged 6–13 years: a longitudinal study. Scand J Public Health. 2014;42(2):128–36.
    1. Vos T, Flaxman AD, Naghavi M, Lozano R, Michaud C, Ezzati M, et al. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990–2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012;380(9859):2163–96.
    1. Aartun E, Hartvigsen J, Wedderkopp N, Hestbaek L. Spinal pain in adolescents: prevalence, incidence, and course: a school-based two-year prospective cohort study in 1,300 Danes aged 11–13. BMC Musculoskelet Disord. 2014;15(1):187.
    1. Hirschfeld G, Zernikow B. Variability of "optimal" cut points for mild, moderate, and severe pain: neglected problems when comparing groups. Pain. 2013;154(1):154–9. doi: 10.1016/j.pain.2012.10.008.
    1. Bronfort G, Haas M, Evans R, Leininger B, Triano J. Effectiveness of manual therapies: the UK evidence report. Chiropr Osteopat. 2010;18:3.
    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 (Phila Pa 1976). 2013;38(8):627–34.
    1. Clar C, Tsertsvadze A, Court R, Hundt GL, Clarke A, Sutcliffe P. Clinical effectiveness of manual therapy for the management of musculoskeletal and non-musculoskeletal conditions: systematic review and update of UK evidence report. Chiropr Man Therap. 2014;22(1):12.
    1. von Heymann WJ, Schloemer P, Timm J, Muehlbauer B. Spinal high-velocity low amplitude manipulation in acute nonspecific low back pain: a double-blinded randomized controlled trial in comparison with diclofenac and placebo. Spine (Phila Pa 1976). 2013;38(7):540–8.
    1. Poulsen E, Hartvigsen J, Christensen HW, Roos EM, Vach W, Overgaard S. Patient education with or without manual therapy compared to a control group in patients with osteoarthritis of the hip. A proof-of-principle three-arm parallel group randomized clinical trial. Osteoarthr Cartil. 2013;21(10):1494–503.
    1. Hestbaek L, Stochkendahl MJ. The evidence base for chiropractic treatment of musculoskeletal conditions in children and adolescents: The emperor's new suit? Chiropr Osteopat. 2010;18:15. doi: 10.1186/1746-1340-18-15.
    1. Gotlib A, Rupert R. Chiropractic manipulation in pediatric health conditions--an updated systematic review. Chiropr Osteopat. 2008;16:11. doi: 10.1186/1746-1340-16-11.
    1. Vaughn DW, Kenyon LK, Sobeck CM, Smith RE. Spinal manual therapy interventions for pediatric patients: a systematic review. J Man Manip Ther. 2012;20(3):153–9.
    1. Gleberzon BJ, Arts J, Mei A, McManus EL. The use of spinal manipulative therapy for pediatric health conditions: a systematic review of the literature. J Can Chiropr Assoc. 2012;56(2):128–41.
    1. Barnes PM, Bloom B, Nahin RL. Complementary and alternative medicine use among adults and children: United States, 2007. Natl Health Stat Report, 200810 (12): p. 1–23
    1. Ndetan H, Evans MW Jr., Hawk C, Walker C. Chiropractic or osteopathic manipulation for children in the United States: an analysis of data from the 2007 National Health Interview Survey. J Altern Complement Med. 2012;18(4):347–53.
    1. Wedderkopp N, Jespersen E, Franz C, Klakk H, Heidemann M, Christiansen C, et al. Study protocol. The childhood health, activity, and motor performance school study denmark (the CHAMPS-study DK). BMC Pediatr. 2012;12:128.
    1. Johansen B, Wedderkopp N. Comparison between data obtained through real-time data capture by SMS and a retrospective telephone interview. Chiropr Osteopat. 2010;18:10. doi: 10.1186/1746-1340-18-10.
    1. Jevne, J., J. Hartvigsen, and H. Wulff Christensen, Compensation claims for chiropractic in Denmark and Norway 2004–2012. In submission, Chiropractic & Manual Therapies, 2014
    1. World Medical Association World medical association declaration of helsinki: ethical principles for medical research involving human subjects. JAMA. 2013;310(20):2191–4. doi: 10.1001/jama.2013.281053.
    1. Schulz C, Leininger B, Evans R, Vavrek D, Peterson D, Haas M, et al. Spinal manipulation and exercise for low back pain in adolescents: study protocol for a randomized controlled trial. Chiropr Man Therap. 2014;22:21.
    1. Stanton TR, Latimer J, Maher CG, Hancock MJ. A modified Delphi approach to standardize low back pain recurrence terminology. Eur Spine J. 2011;20(5):744–52.
    1. Ravens-Sieberer U, Auquier P, Erhart M, Gosch A, Rajmil L, Bruil J, et al. The KIDSCREEN-27 quality of life measure for children and adolescents: psychometric results from a cross-cultural survey in 13 European countries. Qual Life Res. 2007;16(8):1347–56.
    1. Bergmann, T. Chiropractic technique. 3.rd ed. Philadelphia: Churchill Livingstone; 1993.
    1. Millan M, Leboeuf-Yde C, Budgell B, Amorim MA. The effect of spinal manipulative therapy on experimentally induced pain: a systematic literature review. Chiropr Man Therap. 2012;20(1):26.
    1. Millan M, Leboeuf-Yde C, Budgell B, Descarreaux M, Amorim MA. The effect of spinal manipulative therapy on spinal range of motion: a systematic literature review. Chiropr Man Therap. 2012;20(1):23.
    1. Maiers MJ, Hartvigsen J, Schulz C, Schulz K, Evans RL, Bronfort G. Chiropractic and exercise for seniors with low back pain or neck pain: the design of two randomized clinical trials. BMC Musculoskelet Disord. 2007;8:94.
    1. Skargren EI, Oberg BE, Carlsson PG, Gade M. Cost and effectiveness analysis of chiropractic and physiotherapy treatment for low back and neck pain. Six-month follow-up Spine (Phila Pa 1976). 1997;22(18):2167–77.
    1. Leboeuf-Yde C, Nielsen J, Kyvik KO, Fejer R, and Hartvigsen J. Pain in the lumbar, thoracic or cervical regions: do age and gender matter? A population-based study of 34,902 Danish twins 20–71 years of age. BMC Musculoskelet Disord. 2009;10:39.
    1. Leboeuf-Yde C, Fejer R, Nielsen J, Kyvik KO, Hartvigsen J. Consequences of spinal pain: do age and gender matter? A Danish cross-sectional population-based study of 34,902 individuals 20–71 years of age. BMC Musculoskelet Disord. 2011;12:39.
    1. Todd AJ, Carroll MT, Robinson A, Mitchell EK. Adverse events Due to chiropractic and other manual therapies for infants and children: a review of the literature. J Manipulative Physiol Ther. 2014;38(9):699–712.
    1. Tanaka C, Reilly JJ, Huang WY. Longitudinal changes in objectively measured sedentary behaviour and their relationship with adiposity in children and adolescents: systematic review and evidence appraisal. Obes Rev. 2014;15(10):791–803. doi: 10.1111/obr.12195.
    1. Corder K, Sharp SJ, Atkin AJ, Griffin SJ, Jones AP, Ekelund U, et al. Change in objectively measured physical activity during the transition to adolescence. Br J Sports Med. 2015;49(11): p. 730-6
    1. Dumith SC, Gigante DP, Domingues MR, Kohl HW. Physical activity change during adolescence: a systematic review and a pooled analysis. Int J Epidemiol. 2011;40(3):685–98.
    1. Timpka S, Petersson IF, Englund M. The grade in physical education in adolescence as predictor for musculoskeletal pain diagnoses three decades later. Pain. 2010;150(3):414–9. doi: 10.1016/j.pain.2010.03.035.
    1. Wedderkopp N, Kjaer P, Hestbaek L, Korsholm L, Leboeuf-Yde C. High-level physical activity in childhood seems to protect against low back pain in early adolescence. Spine J. 2009;9(2):134–41.
    1. Salmon J, Tremblay MS, Marshall SJ, Hume C. Health risks, correlates, and interventions to reduce sedentary behavior in young people. Am J Prev Med. 2011;41(2):197–206.

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