Chiropractic Treatment for Headache Among Children Aged 7-14
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|ClinicalTrials.gov Identifier: NCT02684916|
Recruitment Status : Recruiting
First Posted : February 18, 2016
Last Update Posted : September 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Chronic Headache||Procedure: Chiropractic treatment Procedure: Placebo||Not Applicable|
The study is a two-armed parallel, randomized controlled clinical trial where children suffering from chronic headache and at the same time having one or more biomechanical dysfunctions of the spine are randomized to either chiropractic manipulation treatment or placebo manipulation treatment.
The outcome is based on weekly sms responses collecting the number of days with headache the past week, intensity of headache and use of medication for headache. These are answered four weeks prior to initiation of treatment and 16 weeks thereafter. After the 16 weeks follow-up, a final questionnaire is completed including information about the course and the present headache status.
The primary outcome is the number of days with headache. Secondary outcomes are intensity of headaches and use of medication for headache.
Covariates are collected via baseline questionnaires on patient demographics; medical history; factors known to initiate, worsen or ease the headache; prevalence of headache in the nearest family; and behavioral patterns known to influence headache.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effectiveness of Chiropractic Manipulation Treatment Versus Placebo Manipulation on Children Aged 7-14 Years With Headache and Musculoskeletal Problems. A Randomized Clinical Trial|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||October 2018|
Experimental: Chiropractic treatment
Visit with active treatment.
Procedure: Chiropractic treatment
The child receives chiropractic manipulation treatment in the neck and in the spine and pelvis according to individual needs. They also receive a written list of general advice regarding lifestyle and habits.
The parents and the child are unaware of group allocation.
Placebo Comparator: Placebo
Visit without active treatment.
Non-therapeutic placebo treatment: a broad non-specific contact outside the spinal column is taken on subject's scapula and gluteal region lying in a side posture position, on the scapulae in a prone position and on trapezius muscles in a sitting position. In those positions the chiropractor pushes in a non-intentional and non- therapeutic directional line with a low-amplitude, low velocity push maneuver. All contacts are performed without soft tissue pre-tension and gentle contact, to insure that no joint cavitation occurs. To obtain a noise that many people associate with a chiropractic spinal adjustment, a de-activated Activator Instrument is used on the arm of the chiropractor to give a click-sound. General advice on lifestyle and habits is handed out to the placebo group as well.
- Difference in number of days per week with headache over four months analyzed as repeated measures with end-point at four months. [ Time Frame: Assessed weekly for a period of four months. ]Patient or parent reported via sms-service.
- Intensity of headache, graded on a 0-10 scale, where 10 is the worst, over four months analyzed as repeated measures with end-point at four months. [ Time Frame: Assessed weekly for a period of four months. ]Patient or parent reported via sms-service.
- Use of medicine the past week due to headache over four months analyzed as repeated measures with end-point at four months. [ Time Frame: Assessed weekly for a period of four months. ]Patient or parent reported via sms-service.
- Improvement on a seven point Likert scale (from 'totally recovered' to 'worse than ever') assessed at four months. [ Time Frame: Assessed at the end of four months follow-up. ]Patient or parent reported via sms-service.
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): NCT02684916
|Contact: Susanne L. Rosing, D.C., MScfirstname.lastname@example.org|
|Contact: Lise Hestbæk, D.C., PhDemail@example.com|
|Kiropraktisk Center og Børneklinik||Recruiting|
|Brønderslev, Denmark, 9700|
|Contact: Susanne L. Rosing, D.C., MSc +4520211234 firstname.lastname@example.org|
|Principal Investigator:||Susanne L. Rosing, D.C., MSC||Nordic Institute of Chiropractic and Clinical Biomechanics|