Potential effect modifiers for treatment with chiropractic manipulation versus sham manipulation for recurrent headaches in children aged 7-14 years: development of and results from a secondary analysis of a randomised clinical trial.

BACKGROUND: A recent randomized controlled trial (RCT) investigating the effect of chiropractic manipulation in 199 children aged 7-14 years with recurrent headaches demonstrated a significant reduction of number of days with headache and a better global perceived effect (GPE) in the chiropractic manipulation group compared to a sham manipulation group. However, potential modifiers for the effectiveness of chiropractic manipulation of children with recurrent headaches have never been identified. The present study is a secondary analysis of data from that RCT and will investigate potential effect modifiers for the benefit of chiropractic manipulation for children with headache. METHODS: Sixteen potential effect modifiers were identified from the literature and a summary index was prespecified based on clinical experience. Relevant variables were extracted from baseline questionnaires, and outcomes were obtained by means of short text messages. The modifying effect of the candidate variables was assessed by fitting interaction models to the data of the RCT. In addition, an attempt to define a new summary index was made. RESULTS: The prespecified index showed no modifying effect. Four single variables demonstrated a treatment effect difference of more than 1 day with headache per week between the lower and the upper end of the spectrum: intensity of headache (p = 0.122), Frequency of headache (p = 0.031), sleep duration (p = 0.243), and Socioeconomic status (p = 0.082). Five variables had a treatment effect difference of more than 0.7 points on the GPE scale between the lower and the upper end of the spectrum: Frequency of headache (p = 0.056), Sport activity (p = 0.110), Sleep duration (p = 0.080), History of neck pain (p = 0.011), and Headache in the family (0.050). A new summary index could be constructed giving highest weight to History of neck pain and Headache in the family and Frequency of headache. The index suggests a difference of about 1 point in GPE between low and high values of the index. CONCLUSION: Chiropractic manipulation offers a moderate benefit for a broad spectrum of children. However, it cannot be excluded that specific headache characteristics, family factors, or a history of neck pain may modify the effect. This question must be addressed in future studies. TRIAL REGISTRATION: ClinicalTrials.gov (Albers et al in Curr Pain Headache Rep 19:3-4, 2015), 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.

BACKGROUND: Headaches in children are poorly described and diagnosing can be challenging. Objectives are: (1) to describe headache characteristics and child characteristics, (2) to explore whether data can suggest a more diverse way to categorize headaches than traditionally. METHODS: Baseline data for a clinical trial included a questionnaire and a physical screening. Children's characteristics and detailed description of headache symptoms were provided. Children were classified for migraine or tension-type-headache based on questionnaire data reported by children and parents. This required to apply slightly modified classification criteria and a "non-classifiable" group was added. Severity and symptoms, related to the migraine versus tension type distinction, were investigated to define a migraine-tension-type-index. RESULTS: 253 children were included. Mean pain intensity was 5.9/10. Over 2/3 of the children had headache for > 1 year, and > 50% for several days/week. Half of the children were non-classifiable, 22% were classified as migraine and 23% as tension-type headache. A migraine-tension-type-index was constructed and describes a continuous spectrum rather than two distinct groups. CONCLUSIONS: Children with recurrent headaches are often severely affected. A questionnaire-based classification appeared feasible to distinguish between migraine and tension-type headaches in children but leaving many children unclassified. A migraine-tension-type-index can be generated allowing to regard the traditional distinction as a continuum (including mixed headache), and potentially serving as an instrument to improve headache management. Trial registration ClinicalTrials.gov, identifier NCT02684916.

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

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.

Musculoskeletal pain distribution in 1,000 Danish schoolchildren aged 8-16 years.

BACKGROUND: Knowledge about the occurrence and distribution of musculoskeletal problems in early life is needed. The objectives were to group children aged 8 to 16 according to their distribution of pain in the spine, lower- and upper extremity, determine the proportion of children in each subgroup, and describe these in relation to sex, age, number- and length of episodes with pain. METHOD: Data on musculoskeletal pain from about 1,000 Danish schoolchildren was collected over 3 school years (2011 to 2014) using weekly mobile phone text message responses from parents, indicating whether their child had pain in the spine, lower extremity and/or upper extremity. Result are presented for each school year individually. RESULTS: When pain was defined as at least 1 week with pain during a school year, Danish schoolchildren could be divided into three almost equally large groups for all three school years: Around 30% reporting no pain, around 40% reporting pain in one region, and around 30% reporting pain in two or three regions. Most commonly children experienced pain from the lower extremities (~ 60%), followed by the spine (~ 30%) and the upper extremities (~ 23%). Twice as many girls reported pain in all three sites compared to boys (10% vs. 5%) with no other statistically significant sex or age differences observed. When pain was defined as at least 3 weeks with pain during a schoolyear, 40% reported pain with similar patterns to those for the more lenient pain definition of 1 week. CONCLUSION: Danish schoolchildren often experienced pain at more than one pain site during a schoolyear, and a significantly larger proportion of girls than boys reported pain in all three regions. This could indicate that, at least in some instances, the musculoskeletal system should be regarded as one entity, both for clinical and research purposes.

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

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.

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.

BACKGROUND: A 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 FINDINGS: The 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. CONCLUSIONS: Adding 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 NUMBER: NCT01504698; Results.

Prevalence and incidence of musculoskeletal extremity complaints in children and adolescents. A systematic review.

BACKGROUND: It is difficult to gain an overview of musculoskeletal extremity complaints in childhood although this is essential to develop evidence-based prevention and treatment strategies. The objectives of this systematic review were therefore to describe the prevalence and incidence of musculoskeletal extremity complaints in children and adolescents in both general and clinical populations in relation to age, anatomical site and mode of onset. METHODS: MEDLINE and EMBASE were electronically searched; risk of bias was assessed; and data extraction was individually performed by two authors. RESULTS: In total, 19 general population studies and three clinical population studies were included with children aged 0-19 years. For most of the analyses, a division between younger children aged 0-12 years, and older children aged 10-19 years was used. Lower extremity complaints were more common than upper extremity complaints regardless of age and type of population, with the most frequent pain site changing from ankle/foot in the youngest to knee in the oldest. There were about twice as many non-traumatic as traumatic complaints in the lower extremities, whereas the opposite relationship was found for the upper extremities in the general population studies. There were relatively more lower extremity complaints in the general population studies than in the clinical population studies. The review showed no pattern of differences in reporting between studies of high and low risk of bias. CONCLUSIONS: This review shows that musculoskeletal complaints are more frequent in the lower extremities than in the upper extremities in childhood, and there are indications of a large amount of non-traumatic low intensity complaints in the population that do not reach threshold for consultation. A meta-analysis, or even a simple overall description of prevalence and incidence of musculoskeletal extremity complaints in children and adolescents was not feasible, due to a large variety in the studies, primarily related to outcome measurements.

Spinal pain in Danish school children - how often and how long? The CHAMPS Study-DK.

BACKGROUND: Spinal pain in children and adolescents is a common condition, usually transitory, but the picture of spinal pain still needs elucidation, mainly due to variation in measurement methods. The aim of this study was to describe the occurrence of spinal pain in 8-15 year-old Danish school children, over a 3-year period. Specifically determining the characteristics of spinal pain in terms of frequency and duration. METHODS: The study was a 3-year prospective longitudinal cohort study including 1400 school children. The outcomes were based on weekly text messages (SMS) to the parents inquiring about the child's musculoskeletal pain, and on clinical data from examinations of the children. RESULTS: The 3-year prevalence was 55%. The prevalence was 29%, 33% and 31% for each of the three study years respectively, and increased statistically significantly with age, especially for lumbopelvic pain. Most children had few and short-lasting episodes with spinal pain, but more than one out of five children had three or more episodes during a study year and 17% of all episodes lasted for more than 4 weeks. CONCLUSION: This study demonstrates that spinal pain is a substantial problem. Most episodes are brief, but there are a vast number of children with frequent and long-lasting episodes of spinal pain indicating a need for action regarding evidence-based prevention and management.

Whose pain is it anyway? Comparability of pain reports from children and their parents.

BACKGROUND: There is a high demand for robust research into understanding the scope and consequences of musculoskeletal pain in children. An important part of this involves clarifying issues surrounding its measurement, not least differences in reporting from the children themselves and their parents. Therefore this study will assess the degree of agreement between parents' report of their child's pain and the child's own assessment. METHODS: Data were collected in 2013 and 2014 as part of a larger cohort study investigating the health of Danish school children. Two study samples included 354 and 334 child-parent pairs who were independently asked whether the child had experienced musculoskeletal pain in the previous week. Children were between the ages of 10 and 14 years old. Parents provided answers via text message and children were questioned in person or via questionnaire at their school. RESULTS: Percentage agreement between parent and child assessment was around 50 % in Sample 1 and 68 % in Sample 2. The poor agreement was due to children reporting pain when their parent did not, the reverse very rarely occurred. Pain of greater intensity or longer duration resulted in better agreement between the child and parent. Child age and gender did not influence the likelihood of agreement. CONCLUSION: Children often experience pain that is not reported by their parents resulting in poor concordance between pain reports from the two sources. While it is not possible to say which is more valid we can conclude they are not interchangeable.

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.

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.