Manipulative Treatment of Children With Neck and Back Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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Manipulative Treatment of Children With Neck and Back Pain. A Randomised Controlled Trial of 1200 Children From 3rd to 7th Grade

Conditions
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Neck Pain, Back Pain

Intervention / Treatment
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* Procedure: Advice and exercise-based treatment plus joint manipulation
* Procedure: Advice and exercise-based treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with manipulation<br> | Procedure: Advice and exercise-based treatment plus joint manipulation<br>* The treatment can consist of advice, activation and exercise and/or manual soft-tissue treatment plus joint manipulation.The areas and frequency of manipulative treatment will be determined by the chiropractor and will consist of high-velocity, low-amplitude manipulation and/or mobilization to the spine and/or the extremities.<br>|
| Active Comparator: Treatment without manipulation<br> | Procedure: Advice and exercise-based treatment<br>* The treatment can consist of advice, activation and exercise and/or manual soft-tissue treatment. However, assisted stretching is not allowed as this will approach mobilization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of recurrences during the follow-up period. | Weekly reports of pain by sms | 2 1/2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global perceived effect after two weeks | Questionnaire | 2 weeks | 
| Change in pain intensity (Numerical Rating Scale) | Questionnaire | After one and two weeks | 
| Average duration of complaint time for each episode | Weekly reports of pain by sms | Up till 2 1/2 years | 
| Total duration of complaint time during the follow-up period (combination of duration and recurrences) |  | 2 1/2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Manipulative treatment, Children, Neck pain, Back pain, Effect, Adolescence, Advise, Exercise