NCT01504698

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
237

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 5, 2012

Completed
27 days until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

May 19, 2015

Status Verified

May 1, 2015

Enrollment Period

2.3 years

First QC Date

January 3, 2012

Last Update Submit

May 18, 2015

Conditions

Neck PainBack Pain

Keywords

Manipulative treatmentChildrenNeck painBack painEffectAdolescenceAdviseExercise

Outcome Measures

Primary Outcomes (1)

  • Number of recurrences during the follow-up period.

    Weekly reports of pain by sms

    2 1/2 year

Secondary Outcomes (4)

  • Global perceived effect after two weeks

    2 weeks

  • Change in pain intensity (Numerical Rating Scale)

    After one and two weeks

  • Average duration of complaint time for each episode

    Up till 2 1/2 years

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

    2 1/2 year

Study Arms (2)

Treatment with manipulation

EXPERIMENTAL
Procedure: Advice and exercise-based treatment plus joint manipulation

Treatment without manipulation

ACTIVE COMPARATOR
Procedure: Advice and exercise-based treatment

Interventions

Advice and exercise-based treatment plus joint manipulationPROCEDURE

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 with manipulation
Advice and exercise-based treatmentPROCEDURE

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.

Treatment without manipulation

Eligibility Criteria

Age8 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Pain in neck or back equal to or greater than 3 on an 11-box numerical rating scale for more than three days.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

13 Municipal Schools

Svendborg, 5700, Denmark

Location

Related Publications (3)

  • 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.

    PMID: 31827767DERIVED

  • 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.

    PMID: 30206079DERIVED

  • 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.

    PMID: 26823970DERIVED

MeSH Terms

Conditions

Neck PainBack PainMotor Activity

Interventions

Counseling

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Niels Wedderkopp, Ph.D.

    University of Southern Denmark

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 3, 2012

First Posted

January 5, 2012

Study Start

February 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

May 19, 2015

Record last verified: 2015-05

Locations

DK(1)