Effectiveness of chiropractic manipulation versus sham manipulation for recurrent headaches in children aged 7–14 years - a randomised clinical trial

Abstract

Background To investigate the effectiveness of chiropractic spinal manipulation versus sham manipulation in children aged 7–14 with recurrent headaches. Methods Design: A two-arm, single-blind, superiority randomised controlled trial. Setting: One chiropractic clinic and one paediatric specialty practice in Denmark, November 2015 to August 2020. Participants: 199 children aged 7 to 14 years, with at least one episode of headache per week for the previous 6 months and at least one musculoskeletal dysfunction identified. Interventions: All participants received standard oral and written advice to reduce headaches. In addition, children in the active treatment group received chiropractic spinal manipulation and children in the control group received sham manipulation for a period of 4 months. Number and frequency of treatments were based on the chiropractor’s individual evaluation in the active treatment group; the children in the control group received approximately eight visits during the treatment period. Primary outcome measures: ‘Number of days with headache’, ‘pain intensity’ and ‘medication’ were reported weekly by text messages, and global perceived effect by text message after 4 months. A planned fixed sequence strategy based on an initial outcome data analysis was used to prioritize outcomes. ‘Number of days with headache’ and ‘pain intensity’ were chosen as equally important outcomes of highest priority, followed by global perceived effect and medication. The significance level for the first two outcomes was fixed to 0.025 to take multiplicity into account. Results Chiropractic spinal manipulation resulted in significantly fewer days with headaches (reduction of 0.81 vs. 0.41, p = 0.019, NNT = 7 for 20% improvement) and better global perceived effect (dichotomized into improved/not improved, OR = 2.8 (95% CI: 1.5–5.3), NNT = 5) compared with a sham manipulation procedure. There was no difference between groups for pain intensity during headache episodes. Due to methodological shortcomings, no conclusions could be drawn about medication use. Conclusions Chiropractic spinal manipulation resulted in fewer headaches and higher global perceived effect, with only minor side effects. It did not lower the intensity of the headaches. Since the treatment is easily applicable, of low cost and minor side effects, chiropractic spinal manipulation might be considered as a valuable treatment option for children with recurrent headaches. Trial registration ClinicalTrials.gov, identifier NCT02684916, registered 02/18/2016 – retrospectively registered.

Description of recurrent headaches in 7–14-year-old children: Baseline data from a randomized clinical trial on effectiveness of chiropractic spinal manipulation in children with recurrent headaches

“…There were 283 children eligible for the pre-screening data collection period, 30 children did not fulfill the inclusion criteria for the screening process and were therefore excluded, and hence, the baseline cohort consisted of 253 children, with 44% boys and a median age of 11 [ 21 ]. Descriptive information about the cohort can be found in the “total” column of Tables 2 and 3 .…”

“…To improve our knowledge about children with recurrent headaches we will take advantage of a population sampled for a randomized controlled trial (RCT) investigating the effectiveness of chiropractic spinal manipulation in children aged 7–14 with recurrent headaches [ 20 , 21 ]. This study collected extensive baseline information on more than 200 children and therefore a detailed description of these children will be reported regarding headache characteristics, co-morbidity, trauma, and physical activity.…”

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 ].…”

“…A single systematic review exploring the effectiveness of spinal manipulation for improving impairments related to headache in children and adolescents [ 104 ], was included and indicated inconclusive results. Two included RCTs [ 52 , 77 ] have explored the effects of spinal manipulation across six different outcomes related to headache in children and adolescents. Whilst one large ( n = 194) RCT [ 77 ] found spinal manipulation significantly reduced the number of days with headache and significantly enhanced the global perceived effect from parents, the collective included evidence exploring the effects of spinal manipulation demonstrated no significant changes to the duration of headache, days of school missed due to headache, consumption of analgesics or intensity of headache (see Supplementary File 5 ).…”

“…Two included RCTs [ 52 , 77 ] have explored the effects of spinal manipulation across six different outcomes related to headache in children and adolescents. Whilst one large ( n = 194) RCT [ 77 ] found spinal manipulation significantly reduced the number of days with headache and significantly enhanced the global perceived effect from parents, the collective included evidence exploring the effects of spinal manipulation demonstrated no significant changes to the duration of headache, days of school missed due to headache, consumption of analgesics or intensity of headache (see Supplementary File 5 ). Subsequently our descriptive synthesis of the collective research revealed there is strong evidence that spinal manipulation has ‘no significant effective’ on headache (Table 5 ).…”