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Acupuncture - a Treatment for Children With Headache

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03426800
Recruitment Status : Recruiting
First Posted : February 8, 2018
Last Update Posted : February 9, 2018
Sponsor:
Information provided by (Responsible Party):
Dorte Melgaard Kristiansen, Vendsyssel Hospital

Brief Summary:
Acupuncture as a treatment for headache in children

Condition or disease Intervention/treatment
Headache Other: Acupuncture and training

Detailed Description:

A randomised controlled study in the effect of acupuncture as a treatment for headache in children.

The children are randomised for training or for training and acupuncture.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acupuncture - a Treatment for Children With Headache
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture Headache
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Migraine_acupuncture and training
Migraine acupuncture and training
Other: Acupuncture and training
Acupuncture twice in the week in 3 weeks combined with training in 6 weeks
Experimental: Migraine training
Migraine training
Other: Acupuncture and training
Acupuncture twice in the week in 3 weeks combined with training in 6 weeks
Experimental: Tension_acupuncture and training
Tension headache acupuncture and training
Other: Acupuncture and training
Acupuncture twice in the week in 3 weeks combined with training in 6 weeks
Experimental: Tension headache training
Tension headache training
Other: Acupuncture and training
Acupuncture twice in the week in 3 weeks combined with training in 6 weeks



Primary Outcome Measures :
  1. Days with headache [ Time Frame: 30 days ]
    Number of days with headache



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed by pediatrician-
  • Age-9-17 years
  • Min. headache 8 times within the last month

Exclusion Criteria:

  • Mentally illness
  • Fear of needles

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): NCT03426800


Contacts
Contact: Dorte Melgaard, PhD +4526281086 dmk@rn.dk
Contact: Dorthe Brønnum dsb@rn.dk

Locations
Denmark
North Denmark Hospital Recruiting
Hjørring, Denmark, 9800
Contact: Dorte Melgaard, PhD       dmk@rn.dk   
Sponsors and Collaborators
Vendsyssel Hospital

Responsible Party: Dorte Melgaard Kristiansen, Research Coordinator, Vendsyssel Hospital
ClinicalTrials.gov Identifier: NCT03426800     History of Changes
Other Study ID Numbers: RHN_DMK_01
First Posted: February 8, 2018    Key Record Dates
Last Update Posted: February 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dorte Melgaard Kristiansen, Vendsyssel Hospital:
Acupuncture
Training
Children
Effect

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