Clinical trial NCT01504698: Manipulative Treatment of Children With Neck and Back Pain
Official title: Manipulative Treatment of Children With Neck and Back Pain. A Randomised Controlled Trial of 1200 Children From 3rd to 7th Grade
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Back Pain
Keywords: Manipulative treatment
Children
Neck pain
Back pain
Effect
Adolescence
Advise
Exercise
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Chiropractors Fund
name: Municipality of Svendborg
name: Nordic Institute of Chiropractic and Clinical Biomechanics
name: Sygehus Lillebaelt
name: IMK Foundation
name: Chiroform
First posted: 2012-01-05
Enrollment: 237
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of manipulative treatment of children with neck and back pain. Because manipulation is the most frequently used treatment of musculoskeletal complaints in children, and an increasing number of Danish children see a chiropractor, it appears obvious to start the search for evidence by examining the effect of this treatment.

Detailed description: Parents receive text messages \[SMS) on a weekly basis inquiring about the child's musculoskeletal pain as well as amount and types of sport during leisure time the past week. Following a report of pain, the parents will be interviewed by phone by a member of the clinical team, consisting of two licensed physical therapists and two licensed chiropractors, for a thorough description of the complaint. Based on this, the interviewer determines whether the complaint is negligible or whether the child should be seen by a member of the clinical team, in which case the child will be examined at his or her school. At this examination, the child will be evaluated for inclusion and exclusion criteria.

Eligibility criteria: Inclusion Criteria:

* Pain in neck or back equal to or greater than 3 on an 11-box numerical rating scale for more than three days.

Exclusion Criteria:

* If a serious pathology or injury is suspected, the child will be referred to a secondary care sports injury center for diagnostic work-up and/or imaging.
* Handicaps which prevents normal physical activity.

Primary outcomes:
measure: Number of recurrences during the follow-up period.
timeFrame: 2 1/2 year
Secondary outcomes:
measure: Global perceived effect after two weeks
timeFrame: 2 weeks
measure: Change in pain intensity (Numerical Rating Scale)
timeFrame: After one and two weeks
measure: Average duration of complaint time for each episode
timeFrame: Up till 2 1/2 years
measure: Total duration of complaint time during the follow-up period (combination of duration and recurrences)
timeFrame: 2 1/2 year
Other outcomes:
Locations:
city: Svendborg
country: Denmark
facility: 13 Municipal Schools
Study officials:
affiliation: University of Southern Denmark
name: Niels Wedderkopp, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Dissing KB, Vach W, Hartvigsen J, Wedderkopp N, Hestbaek L. Potential treatment effect modifiers for manipulative therapy for children complaining of spinal pain.Secondary analyses of a randomised controlled trial. Chiropr Man Therap. 2019 Dec 10;27:59. doi: 10.1186/s12998-019-0282-7. eCollection 2019.
citation: Dissing KB, Hartvigsen J, Wedderkopp N, Hestbaek L. 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. BMJ Open. 2018 Sep 10;8(9):e021358. doi: 10.1136/bmjopen-2017-021358.
citation: Dissing KB, Hartvigsen J, Wedderkopp N, Hestbaek L. 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. Chiropr Man Therap. 2016 Jan 28;24:5. doi: 10.1186/s12998-016-0086-y. eCollection 2016.