NCT03426800

Brief Summary

Acupuncture as a treatment for headache in children

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 8, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2018

Completed
Last Updated

November 28, 2018

Status Verified

November 1, 2018

Enrollment Period

1.2 years

First QC Date

January 25, 2018

Last Update Submit

November 26, 2018

Conditions

Headache

Keywords

AcupunctureTrainingChildrenEffect

Outcome Measures

Primary Outcomes (1)

  • Days with headache

    Number of days with headache

    30 days

Study Arms (4)

Migraine_acupuncture and training

EXPERIMENTAL

Migraine acupuncture and training

Other: Acupuncture and training

Migraine training

EXPERIMENTAL

Migraine training

Other: Acupuncture and training

Tension_acupuncture and training

EXPERIMENTAL

Tension headache acupuncture and training

Other: Acupuncture and training

Tension headache training

EXPERIMENTAL

Tension headache training

Other: Acupuncture and training

Interventions

Acupuncture and trainingOTHER

Acupuncture twice in the week in 3 weeks combined with training in 6 weeks

Migraine trainingMigraine_acupuncture and trainingTension headache trainingTension_acupuncture and training

Eligibility Criteria

Age9 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Mentally illness
  • Fear of needles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Denmark Hospital

Hjørring, 9800, Denmark

Location

MeSH Terms

Conditions

Headache

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Coordinator

Study Record Dates

First Submitted

January 25, 2018

First Posted

February 8, 2018

Study Start

September 1, 2017

Primary Completion

November 6, 2018

Study Completion

November 6, 2018

Last Updated

November 28, 2018

Record last verified: 2018-11

Locations

DK(1)