Potential treatment effect modifiers for manipulative therapy for children complaining of spinal pain.Secondary analyses of a randomised controlled trial

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

Abstract

Background: In children, spinal pain is transitory for most, but up to 20% experience recurrent and bothersome complaints. It is generally acknowledged that interventions may be more effective for subgroups of those affected with low back pain. In this secondary analysis of data from a randomized clinical trial, we tested whether five indicators of a potential increased need for treatment might act as effect modifiers for manipulative therapy in the treatment of spinal pain in children. We hypothesized that the most severely affected children would benefit more from manipulative therapy.

Method: This study was a secondary analysis of data from a randomised controlled trial comparing advice, exercises and soft tissue treatment with and without the addition of manipulative therapy in 238 Danish school children aged 9-15 years complaining of spinal pain. A text message system (SMS) and clinical examinations were used for data collection (February 2012 to April 2014).Five pre-specified potential effect modifiers were explored: Number of weeks with spinal pain 6 months prior to inclusion, number of weeks with co-occurring musculoskeletal pain 6 months prior to inclusion, expectations of the clinical course, pain intensity, and quality of life.Outcomes were number of recurrences of spinal pain, number of weeks with pain, length of episodes, global perceived effect, and change in pain intensity. To explore potential effect modification, various types of regression models were used depending on the type of outcome, including interaction tests.

Results: We found that children with long duration of spinal pain or co-occurring musculoskeletal pain prior to inclusion as well as low quality of life at baseline tended to benefit from manipulative therapy over non-manipulative therapy, whereas the opposite was seen for children reporting high intensity of pain. However, most results were statistically insignificant.

Conclusions: This secondary analysis indicates that children more effected by certain baseline characteristics, but not pain intensity, have a greater chance to benefit from treatment that include manipulative therapy. However, these analyses were both secondary and underpowered, and therefore merely exploratory. The results underline the need for a careful choice of inclusion criteria in future investigations of manipulative therapy in children.

Trial registration: NCT01504698; results.

Keywords: Adolescents; Back pain; Children; Effect modification; Manipulative therapy; Randomised controlled trial; Spinal pain.

Conflict of interest statement

Competing interestsThe authors declare that they have no competing interests.

© The Author(s). 2019.

Figures

Fig. 1
Fig. 1
Number of recurrences. SP: spinal pain. CMP: co-occurring musculoskeletal pain. EoCC: Expectations of the clinical course. NRS: Numerical Rating Scale baseline pain intensity. KID: sum score from KIDScreen questionnaire on quality of life. IRR: incidence rate ratio. CI: confidence interval. p: p-value for interaction. MT: manipulative therapy. Non-MT: non-manipulative therapy
Fig. 2
Fig. 2
Length of spinal pain episode. SP: spinal pain. CMP: co-occurring musculoskeletal pain. EoCC: Expectations of the Clinical Course. NRS: Numerical Rating Scale baseline pain intensity. KID: sum score from KIDScreen questionnaire on quality of life. β-coeff: β-coefficient. CI: confidence interval. p: p-value for interaction. MT: manipulative therapy. Non-MT: non-manipulative therapy
Fig. 3
Fig. 3
Total number of pain weeks. SP: spinal pain. CMP: co-occurring musculoskeletal pain. EoCC: Expectations of the Clinical Course. NRS: Numerical Rating Scale baseline pain intensity. KID: sum score from KIDScreen questionnaire on quality of life. IRR: incidence rate ratio. CI: confidence interval. p: p-value for interaction. MT: manipulative therapy. Non-MT: non-manipulative therapy
Fig. 4
Fig. 4
Global Percieved Effect. SP: spinal pain. CMP: co-occurring musculoskeletal pain. EoCC: Expectations of the Clinical Course. NRS: Numerical Rating Scale baseline pain intensity. KID: sum score from KIDScreen questionnaire on quality of life. IRR: incidence rate ratio. CI: confidence interval. p: p-value for interaction. MT: manipulative therapy. Non-MT: non-manipulative therapy
Fig. 5
Fig. 5
Change in pain intensity. SP: spinal pain. CMP: co-occurring musculoskeletal pain. EoCC: Expectations of the Clinical Course. NRS: Numerical Rating Scale baseline pain intensity. KID: sum score from KIDScreen questionnaire on quality of life. IRR: incidence rate ratio. CI: confidence interval. p: p-value for interaction. MT: manipulative therapy. Non-MT: non-manipulative therapy

References

    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. doi: 10.1186/1471-2474-15-187.
    1. Dissing KB, Hestbaek L, Hartvigsen J, et al. Spinal pain in Danish school children - how often and how long? The CHAMPS Study-DK. BMC musculoskeletal disorders. 2017;18(1):67.
    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):187–199. doi: 10.1016/j.ejpain.2003.08.001.
    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. 2006;31(4):468–472. doi: 10.1097/01.brs.0000199958.04073.d9.
    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. Global Burden of Disease Study C. Global, regional, and national incidence, prevalence, and years lived with disability for 301 acute and chronic diseases and injuries in 188 countries, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013 Lancet. 2015;386(9995):743–800. doi: 10.1016/S0140-6736(15)60692-4.
    1. Black LI, Clarke TC, Barnes PM, Stussman BJ, Nahin RL. Use of complementary health approaches among children aged 4-17 years in the United States: national health interview survey. National health statistics reports. 2007;2015(78):1–19.
    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):347–353. doi: 10.1089/acm.2011.0268.
    1. Hurwitz EL. Epidemiology: spinal manipulation utilization. J Electromyogr Kinesiol. 2012;22(5):648–654. doi: 10.1016/j.jelekin.2012.01.006.
    1. Kjaer P, Kongsted A, Hartvigsen J, et al. National clinical guidelines for non-surgical treatment of patients with recent onset neck pain or cervical radiculopathy. Eur Spine J. 2017;26:2242. doi: 10.1007/s00586-017-5121-8.
    1. Stochkendahl MJ, Kjaer P, Hartvigsen J, et al. National Clinical Guidelines for non-surgical treatment of patients with recent onset low back pain or lumbar radiculopathy. Eur Spine J. 2017.
    1. Koes BW, van Tulder M, Lin CW, et al. An updated overview of clinical guidelines for the management of non-specific low back pain in primary care. Eur Spine J. 2010;19(12):2075–2094. doi: 10.1007/s00586-010-1502-y.
    1. Evans R, Haas M, Schulz C, et al. Spinal manipulation and exercise for low Back pain in adolescents: a randomized trial. Pain. 2018.
    1. Saragiotto BT, Maher CG, Hancock MJ, Koes BW. Subgrouping patients with nonspecific low Back pain: Hope or hype? J Orthop Sports Phys Ther. 2017;47(2):44–48. doi: 10.2519/jospt.2017.0602.
    1. Kent P, Mjosund HL, Petersen DH. Does targeting manual therapy and/or exercise improve patient outcomes in nonspecific low back pain? A systematic review. BMC Med. 2010;8:22. doi: 10.1186/1741-7015-8-22.
    1. Gurung T, Ellard DR, Mistry D, Patel S, Underwood M. Identifying potential moderators for response to treatment in low back pain: a systematic review. Physiotherapy. 2015;101(3):243–251. doi: 10.1016/j.physio.2015.01.006.
    1. Beneciuk JM, Hill JC, Campbell P, et al. Identifying treatment effect modifiers in the STarT Back trial: a secondary analysis. J Pain. 2017;18(1):54–65. doi: 10.1016/j.jpain.2016.10.002.
    1. Dissing KB, Hartvigsen J, Wedderkopp N, Hestbaek L. Conservative care with or without manipulative therapy in the management of back and/or neck pain in Danish children aged 9-15: a randomized controlled trial nested in a school-based cohort. BMJ Open. 2018;8(9):e021358.
    1. Wedderkopp N, Jespersen E, Franz C, et al. Study protocol. The childhood health, activity, and motor performance school study Denmark (the CHAMPS-study DK) BMC Pediatr. 2012;12:128. doi: 10.1186/1471-2431-12-128.
    1. Dissing KB, Hartvigsen J, Wedderkopp N, Hestbaek L. 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. Chiropr Man Therap. 2016;24:5. doi: 10.1186/s12998-016-0086-y.
    1. Hancock M, Herbert RD, Maher CG. A guide to interpretation of studies investigating subgroups of responders to physical therapy interventions. Phys Ther. 2009;89(7):698–704. doi: 10.2522/ptj.20080351.
    1. Hestbaek L, Leboeuf-Yde C, Kyvik KO. Is comorbidity in adolescence a predictor for adult low back pain? A prospective study of a young population. BMC Musculoskelet Disord. 2006;7:29. doi: 10.1186/1471-2474-7-29.
    1. Sheets C, Machado LA, Hancock M, Maher C. Can we predict response to the McKenzie method in patients with acute low back pain? A secondary analysis of a randomized controlled trial. Eur Spine J. 2012;21(7):1250–1256. doi: 10.1007/s00586-011-2082-1.
    1. Hancock MJ, Maher CG, Latimer J, Herbert RD, McAuley JH. Can rate of recovery be predicted in patients with acute low back pain? Development of a clinical prediction rule. Eur J Pain. 2009;13(1):51–55. doi: 10.1016/j.ejpain.2008.03.007.
    1. Stahl M, Kautiainen H, El-Metwally A, et al. Non-specific neck pain in schoolchildren: prognosis and risk factors for occurrence and persistence. A 4-year follow-up study. Pain. 2008;137(2):316–322. doi: 10.1016/j.pain.2007.09.012.
    1. Campbell P, Foster NE, Thomas E, Dunn KM. Prognostic indicators of low back pain in primary care: five-year prospective study. J Pain. 2013;14(8):873–883. doi: 10.1016/j.jpain.2013.03.013.
    1. Bialosky JE, Bishop MD, Cleland JA. Individual expectation: an overlooked, but pertinent, factor in the treatment of individuals experiencing musculoskeletal pain. Phys Ther. 2010;90(9):1345–1355. doi: 10.2522/ptj.20090306.
    1. Myers SS, Phillips RS, Davis RB, et al. Patient expectations as predictors of outcome in patients with acute low back pain. J Gen Intern Med. 2008;23(2):148–153. doi: 10.1007/s11606-007-0460-5.
    1. Sherman KJ, Cherkin DC, Ichikawa L, et al. Characteristics of patients with chronic back pain who benefit from acupuncture. BMC Musculoskelet Disord. 2009;10:114. doi: 10.1186/1471-2474-10-114.
    1. Huguet A, Tougas ME, Hayden J, et al. Systematic review of childhood and adolescent risk and prognostic factors for recurrent headaches. J Pain. 2016;17(8):855–873 e858. doi: 10.1016/j.jpain.2016.03.010.
    1. Dolphens M, Vansteelandt S, Cagnie B, et al. Multivariable modeling of factors associated with spinal pain in young adolescence. Eur Spine J. 2016.
    1. Ravens-Sieberer U, Europe TKG. The KIDSCREEN Questionnaires. Quality of life questionnaires for children and adolescents. Handbook. Lengerich: Pabst Science Publishers; 2006.
    1. Tavakol M, Dennick R. Making sense of Cronbach's alpha. Int J Med Educ. 2011;2:53–55. doi: 10.5116/ijme.4dfb.8dfd.
    1. Peterson RA. A meta-analysis of Cronbach's coefficient alpha. Chicago J. 1994;21(2):381–391.
    1. Balague F, Ferrer M, Rajmil L, et al. Assessing the association between low back pain, quality of life, and life events as reported by schoolchildren in a population-based study. Eur J Pediatr. 2012;171(3):507–514. doi: 10.1007/s00431-011-1596-1.
    1. Hill JC, Lewis M, Sim J, Hay EM, Dziedzic K. Predictors of poor outcome in patients with neck pain treated by physical therapy. Clin J Pain. 2007;23(8):683–690. doi: 10.1097/AJP.0b013e3181468e67.
    1. Miro J, Castarlenas E, Huguet A. Evidence for the use of a numerical rating scale to assess the intensity of pediatric pain. Eur J Pain. 2009;13(10):1089–1095. doi: 10.1016/j.ejpain.2009.07.002.
    1. von Baeyer CL, Spagrud LJ, McCormick JC, et al. Three new datasets supporting use of the numerical rating scale (NRS-11) for children's self-reports of pain intensity. Pain. 2009;143(3):223–227. doi: 10.1016/j.pain.2009.03.002.
    1. Hancock MJ, Kjaer P, Korsholm L, Kent P. Interpretation of subgroup effects in published trials. Phys Ther. 2013;93(6):852–859. doi: 10.2522/ptj.20120296.
    1. Pincus T, Miles C, Froud R, et al. Methodological criteria for the assessment of moderators in systematic reviews of randomised controlled trials: a consensus study. BMC Med Res Methodol. 2011;11:14. doi: 10.1186/1471-2288-11-14.
    1. Petersen T, Christensen R, Juhl C. Predicting a clinically important outcome in patients with low back pain following McKenzie therapy or spinal manipulation: a stratified analysis in a randomized controlled trial. BMC Musculoskelet Disord. 2015;16:74. doi: 10.1186/s12891-015-0526-1.
    1. Jensen RK, Kent P, Hancock M. Do MRI findings identify patients with chronic low back pain and Modic changes who respond best to rest or exercise: a subgroup analysis of a randomised controlled trial. Chiropr Man Therap. 2015;23:26. doi: 10.1186/s12998-015-0071-x.
    1. Underwood MR, Morton V, Farrin A, Team UBT. Do baseline characteristics predict response to treatment for low back pain? Secondary analysis of the UK BEAM dataset [ISRCTN32683578] Rheumatology (Oxford) 2007;46(8):1297–1302. doi: 10.1093/rheumatology/kem113.

Source: PubMed

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe