Conservative care with or without manipulative therapy in the management of back and/or neck pain in Danish children aged 9–15: a randomised controlled trial nested in a school-based cohort

Abstract

BackgroundA substantial number of children experience spinal pain, that is, back and/or neck pain. Today, no ‘gold-standard’ treatment for spinal pain in children exists, but manipulative therapy is increasingly being used in spite of a lack of evidence of its effectiveness. This study investigates the effectiveness of adding manipulative therapy to other conservative care for spinal pain in a school-based cohort of Danish children aged 9–15 years.Methods and findingsThe design was a two-arm pragmatic randomised controlled trial, nested in a longitudinal open cohort study in Danish public schools. 238 children from 13 public schools were randomised individually from February 2012 to April 2014. A text message system and clinical examinations were used for data collection. Interventions included either (1) advice, exercises and soft-tissue treatment or (2) advice, exercises and soft-tissue treatment plus manipulative therapy. The primary outcome was number of recurrences of spinal pain. Secondary outcomes were duration of spinal pain, change in pain intensity and Global Perceived Effect.We found no significant difference between groups in the primary outcome (control group median 1 (IQR 1–3) and intervention group 2 (IQR 0–4), p=0.07). Children in the group receiving manipulative therapy reported a higher Global Perceived Effect: OR 2.22, (95% CI 1.19 to 4.15). No adverse events were reported. Main limitations are the potential discrepancy between parental and child reporting and that the study population may not be comparable to a normal care-seeking population.ConclusionsAdding manipulative therapy to other conservative care in school children with spinal pain did not result in fewer recurrent episodes. The choice of treatment—if any—for spinal pain in children therefore relies on personal preferences, and could include conservative care with and without manipulative therapy. Participants in this trial may differ from a normal care-seeking population.Trial registration numberNCT01504698; Results.

What are important consequences in children with non-specific spinal pain? A qualitative study of Danish children aged 9–12 years

“…Another reason could relate to uncertainty regarding the validity of self-reported pain in children. 46 The other issue was 'cause not known' reflecting the children's desire to know why they had pain. This was excluded as it refers to aetiology of the pain.…”

Spinal manipulation and mobilisation in the treatment of infants, children, and adolescents: a systematic scoping review

“…From the 18 studies included in the descriptive synthesis that explored the effectiveness of spinal manipulation in paediatric populations, one was focused on AIS [ 59 ], two on asthma [ 49 , 56 ], four on back/neck pain [ 57 , 63 , 67 , 89 ], one on CP [ 74 ], two on headache [ 52 , 77 ], six on infantile colic – excessive crying / behaviours [ 53 , 58 , 68 , 71 , 85 , 92 ], one on infantile colic – sleeping disturbances [ 58 ] and one on torticollis [ 70 ].…”

“…Two reviews [ 104 , 109 ] explored the effectiveness of spinal manipulation for managing low back pain severity, with one review [ 104 ] ( n = 1 RCT and 1 observational study exploring 239 participants) concluding favourable outcomes for reducing a mixture of acute and chronic back pain severity in children and adolescents, with the second review [ 109 ] finding inconclusive results regarding the effectiveness of spinal manipulation for managing a mixture of acute and chronic spinal pain. Additionally, four studies [ 57 , 63 , 67 , 89 ] explored the effects of back and neck pain (with mixed acute and chronic presentations) in children and adolescents. One well powered RCT [ 67 ] showed spinal manipulation (added to exercise) had significant favourable effects on reducing chronic low back pain severity and one lower quality study [ 57 ] showed spinal manipulation resulted in significantly favourable reductions in severity of acute back pain.…”

Pragmatic trials of pain therapies: a systematic review of methods

“…Fifty-four of 57 trials (95%) reported that patients gave informed consent, with none of the trials stating clearly what this information and consent process entailed. In 2 trials, 30 , 106 consent for patients was waived. In a third trial, 2 the unit of randomization was physicians for whom consent was not required; patients, however, did provide informed consent.…”

“…The primary time point at which outcomes were measured was a median of 26 weeks postrandomization (Q1/3: 8; 52 weeks; n = 36) ranging from a single day 104 to 5 years. 6 However, there were many studies that assessed outcomes over a period, 5 , 9 , 30 , 34 , 97 , 102 , 106 at flexible time points, 50 , 81 , 108 studies that defined several time points as primary, 75 , 111 and several that did not specify a primary point of follow-up. 3 , 8 , 26 , 59 , 66 , 83 , 109 , 122 A better indicator for how long self-declared pragmatic trials are, may thus be the longest time point of follow-up, for which the median was about one year after randomization (median 50 weeks, Q1/3; 23.25; 52 weeks; n = 56; not reported in one case 50 ).…”