Back to resultsAcupuncture - a Treatment for Children With Headache
Primary Purpose
Headache
Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Acupuncture and training
Sponsored by
About this trial
This is an interventional treatment trial for Headache focused on measuring Acupuncture, Training, Children, Effect
Eligibility 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
Sites / Locations
- North Denmark Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Migraine_acupuncture and training
Migraine training
Tension_acupuncture and training
Tension headache training
Arm Description
Migraine acupuncture and training
Migraine training
Tension headache acupuncture and training
Tension headache training
Outcomes
Primary Outcome Measures
Days with headache
Number of days with headache
Secondary Outcome Measures
Full Information
NCT ID
NCT03426800
First Posted
January 25, 2018
Last Updated
November 26, 2018
Sponsor
Vendsyssel Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03426800
Brief Title
Acupuncture - a Treatment for Children With Headache
Official Title
Acupuncture - a Treatment for Children With Headache
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Terminated
Why Stopped
Limited numbers of patients
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
November 6, 2018 (Actual)
Study Completion Date
November 6, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vendsyssel Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Acupuncture as a treatment for headache in children
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache
Keywords
Acupuncture, Training, Children, Effect
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Migraine_acupuncture and training
Arm Type
Experimental
Arm Description
Migraine acupuncture and training
Arm Title
Migraine training
Arm Type
Experimental
Arm Description
Migraine training
Arm Title
Tension_acupuncture and training
Arm Type
Experimental
Arm Description
Tension headache acupuncture and training
Arm Title
Tension headache training
Arm Type
Experimental
Arm Description
Tension headache training
Intervention Type
Other
Intervention Name(s)
Acupuncture and training
Intervention Description
Acupuncture twice in the week in 3 weeks combined with training in 6 weeks
Primary Outcome Measure Information:
Title
Days with headache
Description
Number of days with headache
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
North Denmark Hospital
City
Hjørring
ZIP/Postal Code
9800
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Acupuncture - a Treatment for Children With Headache
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