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Manipulative Treatment of Children With Neck and Back Pain

Primary Purpose

Neck Pain, Back Pain

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Advice and exercise-based treatment plus joint manipulation
Advice and exercise-based treatment
Sponsored by
University of Southern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Manipulative treatment, Children, Neck pain, Back pain, Effect, Adolescence, Advise, Exercise

Eligibility Criteria

8 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • 13 Municipal Schools

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment with manipulation

Treatment without manipulation

Arm Description

Outcomes

Primary Outcome Measures

Number of recurrences during the follow-up period.
Weekly reports of pain by sms

Secondary Outcome Measures

Global perceived effect after two weeks
Questionnaire
Change in pain intensity (Numerical Rating Scale)
Questionnaire
Average duration of complaint time for each episode
Weekly reports of pain by sms
Total duration of complaint time during the follow-up period (combination of duration and recurrences)

Full Information

First Posted
January 3, 2012
Last Updated
May 18, 2015
Sponsor
University of Southern Denmark
Collaborators
Chiropractors Fund, Municipality of Svendborg, Nordic Institute of Chiropractic and Clinical Biomechanics, Sygehus Lillebaelt, IMK Foundation, Chiroform
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1. Study Identification

Unique Protocol Identification Number
NCT01504698
Brief Title
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

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern Denmark
Collaborators
Chiropractors Fund, Municipality of Svendborg, Nordic Institute of Chiropractic and Clinical Biomechanics, Sygehus Lillebaelt, IMK Foundation, Chiroform

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Back Pain
Keywords
Manipulative treatment, Children, Neck pain, Back pain, Effect, Adolescence, Advise, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
237 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment with manipulation
Arm Type
Experimental
Arm Title
Treatment without manipulation
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Advice and exercise-based treatment plus joint manipulation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Advice and exercise-based treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of recurrences during the follow-up period.
Description
Weekly reports of pain by sms
Time Frame
2 1/2 year
Secondary Outcome Measure Information:
Title
Global perceived effect after two weeks
Description
Questionnaire
Time Frame
2 weeks
Title
Change in pain intensity (Numerical Rating Scale)
Description
Questionnaire
Time Frame
After one and two weeks
Title
Average duration of complaint time for each episode
Description
Weekly reports of pain by sms
Time Frame
Up till 2 1/2 years
Title
Total duration of complaint time during the follow-up period (combination of duration and recurrences)
Time Frame
2 1/2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niels Wedderkopp, Ph.D.
Organizational Affiliation
University of Southern Denmark
Official's Role
Study Director
Facility Information:
Facility Name
13 Municipal Schools
City
Svendborg
ZIP/Postal Code
5700
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
31827767
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.
Results Reference
derived
PubMed Identifier
30206079
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.
Results Reference
derived
PubMed Identifier
26823970
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.
Results Reference
derived

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Manipulative Treatment of Children With Neck and Back Pain

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