Chiropractic spinal manipulative therapy for acute neck pain: A 4-arm clinical placebo randomized controlled trial. A prospective study protocol.

INTRODUCTION: Neck pain poses enormous individual and societal costs worldwide. Spinal manipulative therapy and Non-Steroidal Anti-Inflammatory Drug treatment are frequently used despite a lack of compelling efficacy data. This protocol describes a multicentre 4-arm, clinical placebo randomized controlled trial (RCT), investigating the efficacy of chiropractic spinal manipulative therapy (CSMT) versus sham CSMT, ibuprofen, and placebo medicine for acute neck pain. This superiority study will employ parallel groups, featuring a 1:1:1:1 allocation ratio. MATERIAL AND METHODS: We will randomize 320 participants equally into four groups: CSMT, sham CSMT, ibuprofen, or placebo medicine. CSMT groups are single-blinded, while the medicine groups are double-blinded. Data will be collected at baseline (Day 0), during treatment and post-treatment. The primary endpoint will assess the difference in mean pain intensity from Day 0 to Day 14 on a numeric rating scale 0-10; the CSMT group is compared to sham CSMT, ibuprofen, and placebo medicine groups, respectively. Secondary endpoints will assess mean pain intensity and mean duration at different time points, and adverse events, blinding success, and treatment satisfaction, including comparison between ibuprofen and placebo medicine. Power calculation is based on a mean neck pain rating of 5 at Day 0, with standard deviation of 1 in all groups. Mean pain reduction at Day 14 is expected to be 60% in the CSMT group, 40% in sham CSMT and ibuprofen groups, and 20% in the placebo medicine group. A linear mixed model will compare the mean values for groups with corresponding 95% confidence intervals. P values below 0.017 will be considered statistically significant. All analyses will be conducted blinded from group allocation. DISCUSSION: This RCT aims towards the highest research standards possible for manual-therapy RCTs owing to its two placebo arms. If CSMT and/or ibuprofen proves to be effective, it will provide evidence-based support for CSMT and/or ibuprofen for acute neck pain. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT05374057. EU Clinical Trials Register: EudraCT number: 2021-005483-21.

Children and adolescents presenting to chiropractors in Norway: National Health Insurance data and a detailed survey.

BACKGROUND: The idea of chiropractors treating children is controversial, yet many parents seek chiropractic care for their children. The reasons for this are not well documented. Part one of this study aimed to document the profile of all paediatric patients consulting Norwegian chiropractors in 2013 using National Health Insurance data (NHI) with regards to age, gender and primary complaints. Part two aimed to provide a more detailed description of these patients in the form of a descriptive, paper-based survey. METHODS: Part one involved Norwegian NHI data from 2013. Part two consisted of a year-long, paper-based survey. Chiropractors registered with the Norwegian chiropractic association (NKF) were invited to participate via email. Participating chiropractors were assigned one random month to collect data. All paediatric patients (or their parents) during that were asked to complete questionnaires containing information on presenting complaint, consequences of this complaint, age, and mode of referral. RESULTS: In general, there was good concordance between part one and two of the study in terms of age, gender and presenting complaint. The youngest children constituted the largest paediatric group in Norwegian chiropractic practice. Musculoskeletal problems were the most common reason for children visiting a chiropractor in all of the age categories, according to NHI data. Part two of the study found that one-third of young school children and adolescents reported pain lasting longer than 1-year. Eleven percent of children found that their complaint had severely affected their mood and 22 % felt their activities were very limited by their condition. Referrals from healthcare professionals were uncommon. The survey's results were based on 161 completed questionnaires, received from 15 % of the Norwegian chiropractors. CONCLUSIONS: Musculoskeletal problems constituted the most common presenting complaint for children and adolescents presenting to Norwegian chiropractors. A sizable proportion of children seemed to be adversely affected by their complaints in terms of low mood and limitations of daily activities. Chronic presentations were not uncommon. The small sample size of the survey demands that the results be interpreted with caution.