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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
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The primary aim of the study is to assess the effectiveness of chiropractic manipulation treatment versus placebo treatment in children suffering from headache for more than six months.

Condition or disease Intervention/treatment
Chronic Headache Procedure: Chiropractic treatment Procedure: Placebo

Detailed Description:

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.
Procedure: Placebo
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.


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria

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Ages Eligible for Study:   7 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Headaches for at least half a year.
  • Headache for at least 4 days pr. month.
  • At least one musculoskeletal dysfunction as identified by an experienced chiropractor as a movement restriction in one or more of the spinal joints and painful on manual palpation suitable for chiropractic manipulation treatment at the time of the initial screening.
  • Able to report information on headache via cell phone either by him- or herself or with help from the parents.

Exclusion Criteria:

  • Contraindications for chiropractic treatment
  • Ongoing treatment for headache at another practitioner, except medical treatment 3 months prior to inclusion.
  • Lack of reporting baseline data via sms 4 weeks prior to inclusion.
  • Acute neck or head trauma during the trial period which is estimated to influence the headache
Contacts and Locations

Information from the National Library of Medicine

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


Contacts
Contact: Susanne L. Rosing, D.C., MSc +4520211234 sl@kiropraktiskcenter.dk
Contact: Lise Hestbæk, D.C., PhD +4565504530 l.hestbaek@nikkb.dk

Locations
Denmark
Kiropraktisk Center og Børneklinik Recruiting
Brønderslev, Denmark, 9700
Contact: Susanne L. Rosing, D.C., MSc    +4520211234    sl@kiropraktiskcenter.dk   
Sponsors and Collaborators
Nordic Institute of Chiropractic and Clinical Biomechanics
University of Southern Denmark
Investigators
Principal Investigator: Susanne L. Rosing, D.C., MSC Nordic Institute of Chiropractic and Clinical Biomechanics
More Information

Responsible Party: Nordic Institute of Chiropractic and Clinical Biomechanics
ClinicalTrials.gov Identifier: NCT02684916     History of Changes
Other Study ID Numbers: 1504
First Posted: February 18, 2016    Key Record Dates
Last Update Posted: September 22, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Nordic Institute of Chiropractic and Clinical Biomechanics:
Chiropractic spinal manipulation
Children
Pediatric
Headache

Additional relevant MeSH terms:
Headache
Headache Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases