Manipulative Treatment of Children With Neck and Back Pain
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|ClinicalTrials.gov Identifier: NCT01504698|
Recruitment Status : Completed
First Posted : January 5, 2012
Last Update Posted : May 19, 2015
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|Condition or disease||Intervention/treatment||Phase|
|Neck Pain Back Pain||Procedure: Advice and exercise-based treatment plus joint manipulation Procedure: Advice and exercise-based treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||237 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Manipulative Treatment of Children With Neck and Back Pain. A Randomised Controlled Trial of 1200 Children From 3rd to 7th Grade|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
|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.
- Number of recurrences during the follow-up period. [ Time Frame: 2 1/2 year ]Weekly reports of pain by sms
- Global perceived effect after two weeks [ Time Frame: 2 weeks ]Questionnaire
- Change in pain intensity (Numerical Rating Scale) [ Time Frame: After one and two weeks ]Questionnaire
- Average duration of complaint time for each episode [ Time Frame: Up till 2 1/2 years ]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 ]
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|Ages Eligible for Study:||8 Years to 15 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Pain in neck or back equal to or greater than 3 on an 11-box numerical rating scale for more than three days.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01504698
|13 Municipal Schools|
|Svendborg, Denmark, 5700|
|Study Director:||Niels Wedderkopp, Ph.D.||University of Southern Denmark|
|Responsible Party:||Kristina Boe Dissing, Principal Investigator, University of Southern Denmark|
|Other Study ID Numbers:||
|First Posted:||January 5, 2012 Key Record Dates|
|Last Update Posted:||May 19, 2015|
|Last Verified:||May 2015|