Manipulative Treatment of Children With Neck and Back Pain

Not Applicable

Completed

• Conditions: Neck Pain; Back Pain
• Interventions: Procedure: Advice and exercise-based treatment; Procedure: Advice and exercise-based treatment plus joint manipulation

• Registration Number: NCT01504698
• Lead Sponsor: University of Southern Denmark

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.

Study Timeline

• Study First Submitted: 2012-01-03
• Study First Submitted QC: 2012-01-04
• Study First Posted: 2012-01-05
• Study Start: 2012-02
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-18
• Last Update Posted: 2015-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 237

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment without manipulation	Advice and exercise-based treatment	-
Treatment with manipulation	Advice and exercise-based treatment plus joint manipulation	-

Primary Outcome Measures

Name	Time	Method
Number of recurrences during the follow-up period.	2 1/2 year	Weekly reports of pain by sms

Secondary Outcome Measures

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

Trial Locations

Locations (1)

13 Municipal Schools; 🇩🇰 Svendborg, Denmark