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: 1. Pragmatic advice, manual soft tissue treatment and exercises. 2. The 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 ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12998-016-0086-y) contains supplementary material, which is available to authorized users.