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Manipulative Treatment of Children With Neck and Back Pain

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Chiropractors Fund
Municipality of Svendborg
Nordic Institute of Chiropractic and Clinical Biomechanics
Spine Center South at Lillebælt Hospital
IMK Foundation
Chiroform
Information provided by (Responsible Party):
Kristina Boe Dissing, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01504698
First received: January 3, 2012
Last updated: January 8, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention
Neck Pain
Back Pain
 Procedure: Advice and exercise-based treatment plus joint manipulation
Procedure: Advice and exercise-based treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Manipulative Treatment of Children With Neck and Back Pain. A Randomised Controlled Trial of 1200 Children From 3rd to 7th Grade

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • Number of recurrences during the follow-up period. [ Time Frame: 2 1/2 year ] [ Designated as safety issue: No ]
    Weekly reports of pain by sms


Secondary Outcome Measures:
  • Global perceived effect after two weeks [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Questionnaire

  • Change in pain intensity (Numerical Rating Scale) [ Time Frame: After one and two weeks ] [ Designated as safety issue: No ]
    Questionnaire

  • Average duration of complaint time for each episode [ Time Frame: Up till 2 1/2 years ] [ Designated as safety issue: No ]
    Weekly reports of pain by sms

  • Total duration of complaint time during the follow-up period (combination of duration and recurrences) [ Time Frame: 2 1/2 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: February 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment with manipulation 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.
Active Comparator: Treatment without manipulation Procedure: 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.

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

Ages Eligible for Study:   8 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01504698

Locations
Denmark
13 Municipal Schools
Svendborg, Denmark, 5700
Sponsors and Collaborators
University of Southern Denmark
Chiropractors Fund
Municipality of Svendborg
Nordic Institute of Chiropractic and Clinical Biomechanics
Spine Center South at Lillebælt Hospital
IMK Foundation
Chiroform
Investigators
Study Director: Niels Wedderkopp, Ph.D. University of Southern Denmark
  More Information

No publications provided

Responsible Party: Kristina Boe Dissing, Principal Investigator, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01504698     History of Changes
Other Study ID Numbers: CVKS-20110042
Study First Received: January 3, 2012
Last Updated: January 8, 2012
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by University of Southern Denmark:
Manipulative treatment
Children
Neck pain
Back pain
 Effect
Adolescence
Advise
Exercise

Additional relevant MeSH terms:
Back Pain
Neck Pain
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on June 13, 2013