Manipulative Treatment of Children With Neck and Back Pain

Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01504698
• Other study ID #: CVKS-20110042
• Status: Completed
• Phase: N/A
• First received: January 3, 2012
• Last updated: May 18, 2015
• Start date: February 2012
• Est. completion date: June 2014

Study information

• Verified date: May 2015
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 15 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Neck Pain

Intervention

Procedure:
• Advice and exercise-based treatment plus joint manipulation
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.
• Advice and exercise-based treatment
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.

Locations

Country	Name	City	State
Denmark	13 Municipal Schools	Svendborg

Sponsors (7)

Lead Sponsor	Collaborator
University of Southern Denmark	Chiroform, Chiropractors Fund, IMK Foundation, Municipality of Svendborg, Nordic Institute of Chiropractic and Clinical Biomechanics, Sygehus Lillebaelt

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of recurrences during the follow-up period.	Weekly reports of pain by sms	2 1/2 year	No
Secondary	Global perceived effect after two weeks	Questionnaire	2 weeks	No
Secondary	Change in pain intensity (Numerical Rating Scale)	Questionnaire	After one and two weeks	No
Secondary	Average duration of complaint time for each episode	Weekly reports of pain by sms	Up till 2 1/2 years	No
Secondary	Total duration of complaint time during the follow-up period (combination of duration and recurrences)		2 1/2 year	No