Manipulative Treatment of Children With Neck and Back Pain

NCT ID: NCT01504698

Last Updated: 2015-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

237 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-06-30

Brief Summary

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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

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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.

Conditions

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Neck Pain Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment with manipulation

Group Type EXPERIMENTAL

Advice and exercise-based treatment plus joint manipulation

Intervention Type 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.

Treatment without manipulation

Group Type ACTIVE_COMPARATOR

Advice and exercise-based treatment

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chiropractors Fund

UNKNOWN

Sponsor Role collaborator

Municipality of Svendborg

UNKNOWN

Sponsor Role collaborator

Nordic Institute of Chiropractic and Clinical Biomechanics

OTHER

Sponsor Role collaborator

Sygehus Lillebaelt

OTHER

Sponsor Role collaborator

IMK Foundation

UNKNOWN

Sponsor Role collaborator

Chiroform

UNKNOWN

Sponsor Role collaborator

University of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

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Kristina Boe Dissing

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Niels Wedderkopp, Ph.D.

Role: STUDY_DIRECTOR

University of Southern Denmark

Locations

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13 Municipal Schools

Svendborg, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 31827767 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30206079 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26823970 (View on PubMed)

Other Identifiers

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CVKS-20110042

Identifier Type: -

Identifier Source: org_study_id

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