En randomiseret kontrolleret undersøgelseA randomised 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. Consequently, early prevention and early effective treatment must be prioritized. Despite lack of evidence of effectiveness, joint manipulation is the most commonly used treatment modality for spine complaints in children. The primary objective of this study is to evaluate the additional clinical effect of manipulative therapy when combined with other types of conservative care in the treatment of neck- and back-related complaints in children. Method The project is nested in the “Svendborg Project”, which includes around 1500 children aged 10-13 yoa. Of these, about 900 have accepted to participate in this RCT should they experience spine pain during a 2 ½ year period. Parents receive text messages (SMS) on a weekly basis inquiring about the child’s musculoskeletal pain. If pain is reported, the child will be evaluated for inclusion in the trial by a member of the clinical team at his or her school. Inclusion criteria: Pain in neck or back at 3 or more on an 11-box NRS for at least three days. Exclusion criteria: Serious pathology or injury, handicaps preventing normal physical activity. Randomization: Blockrandomzation with 1:1 allocation Design: Single blind Treatment: 1) pragmatic advice, soft tissue treatment and exercise-based treatment. 2) the above plus joint manipulation. The type and frequency of treatments will be determined and performed by licensed chiropractors. Outcome measures: The primary outcome measures are change in pain intensity and global perceived effect after two weeks. Secondary outcome measures include duration of complaint and number of recurrences during follow-up (6 to 27 months). Modifying factors: Quality of life, physical activity, motor competence and satisfaction with treatment. Results We want to evaluate the clinical effectiveness of manipulative therapy in addition to other types of conservative care in the treatment of neck- and back-related complaints in children by comparing the two groups. The trial is ongoing and recruiting. Clinicaltrial.gov registration number: NCT01504698 Conclusions To our knowledge this is the first large scale randomized clinical trial investigating the effectiveness of commonly used treatments for spine pain in children.
Manipulation, Chiropractic; children; Adolescent; Neck Pain; back pain