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Completed

NCT Number: NCT01504698

Manipulative Treatment of Children With Neck and Back Pain

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.

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Key information

Conditions

Neck Pain Back Pain Behavior Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

8 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

13 Municipal Schools

Svendborg, 5700, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Advice and exercise-based treatment plus joint manipulation

Procedure

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

Procedure

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 outcomes

  1. Number of recurrences during the follow-up period.

    Time frame: 2 1/2 year

    Weekly reports of pain by sms

Secondary outcomes

  1. Global perceived effect after two weeks

    Time frame: 2 weeks

    Questionnaire

  2. Change in pain intensity (Numerical Rating Scale)

    Time frame: After one and two weeks

    Questionnaire

  3. Average duration of complaint time for each episode

    Time frame: Up till 2 1/2 years

    Weekly reports of pain by sms

  4. Total duration of complaint time during the follow-up period (combination of duration and recurrences)

    Time frame: 2 1/2 year

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Chiroform
  • Chiropractors Fund
  • IMK Foundation
  • Municipality of Svendborg
  • Nordic Institute of Chiropractic and Clinical Biomechanics
  • Sygehus Lillebaelt

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 5, 2012
Registry last updated
May 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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