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CompletedNCT01504698Updated May 19, 2015

Manipulative Treatment of Children With Neck and Back Pain

An interventional study of Advice and exercise-based treatment plus joint manipulation and Advice and exercise-based treatment in Neck Pain and Back Pain, sponsored by University of Southern Denmark. Completed at 1 site in Denmark. Open to participants aged 8 Years to 15 Years. Per ClinicalTrials.gov, last updated 2015-05-19.

Sponsored by University of Southern Denmark · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
237
Allocation
Randomized
Ages
8 Years to 15 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Neck Pain
  • Back Pain

Keywords

  • Manipulative treatment
  • Children
  • Neck pain
  • Back pain
  • Effect
  • Adolescence
  • Advise
  • Exercise
03

In context

Neck Pain

1,259 studies on the registry are indexed under Neck Pain; 256 are open to participants now.

This study's enrollment of 237 is above the median of 52 across 1,026 interventional studies indexed under Neck Pain.

Browse Neck Pain studies →

Lead sponsor

University of Southern Denmark is the lead sponsor of 335 studies on the registry; 45 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
237 participants (actual)

Study arms

  • Experimental
    Treatment with manipulation

    Procedure: Advice and exercise-based treatment plus joint manipulation

  • Active comparator
    Treatment without manipulation

    Procedure: Advice and exercise-based treatment

Interventions

  • ProcedureAdvice 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.

  • ProcedureAdvice 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.

06

What researchers measure

Primary outcomes

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

    Weekly reports of pain by sms

    Time frame: 2 1/2 year

Secondary outcomes

  1. Global perceived effect after two weeks

    Questionnaire

    Time frame: 2 weeks

  2. Change in pain intensity (Numerical Rating Scale)

    Questionnaire

    Time frame: After one and two weeks

  3. Average duration of complaint time for each episode

    Weekly reports of pain by sms

    Time frame: Up till 2 1/2 years

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

    Time frame: 2 1/2 year

07

Study locations

1 site
  • 13 Municipal Schools
    Svendborg, 5700, Denmark
08

References and documents

Publications

  • 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. PubMed 31827767 ↗
  • 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. PubMed 30206079 ↗
  • 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. PubMed 26823970 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01504698
Collaborators
Chiropractors Fund, Municipality of Svendborg, Nordic Institute of Chiropractic and Clinical Biomechanics, Sygehus Lillebaelt, IMK Foundation, Chiroform
Responsible party
Kristina Boe Dissing (Principal Investigator, University of Southern Denmark) — Principal investigator
First posted
Jan 5, 2012
Start date
Feb 2012
Primary completion
Jun 2014
Completion
Jun 2014
Last update
May 19, 2015

Study contacts

Niels Wedderkopp, Ph.D.
study director · University of Southern Denmark

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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