HeadacheNCT03426800
Acupuncture - a Treatment for Children With Headache
A study testing Acupuncture and training in people with Headache, run by Regionshospital Nordjylland at 1 site in Denmark.
Trial summary
Acupuncture as a treatment for headache in children Read more about this study
- Who is it for?
- Ages 9 to 17 years
- Conditions the study is for
- Headache
- What is being tested?
- Acupuncture and training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2017to 6 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed by pediatrician-
- Age-9-17 years
- Min. headache 8 times within the last month
Who cannot join
- Mentally illness
- Fear of needles
Trial locations and contacts
1 site in 1 country.
About this study
Acupuncture as a treatment for headache in children
Read the 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.
- Conditions
- Headache
- Being tested
- Acupuncture and training
- Keywords
- Acupuncture, Training, Children, Effect
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture and trainingOther
Acupuncture twice in the week in 3 weeks combined with training in 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Migraine_acupuncture and training | Experimental | Migraine acupuncture and training Receives: Other: Acupuncture and training |
| Migraine training | Experimental | Migraine training Receives: Other: Acupuncture and training |
| Tension_acupuncture and training | Experimental | Tension headache acupuncture and training Receives: Other: Acupuncture and training |
| Tension headache training | Experimental | Tension headache training Receives: Other: Acupuncture and training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days with headache
Number of days with headache
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start1 Sep 2017
- Primary completion6 Nov 2018
- Study completion6 Nov 2018
Why it stopped: Limited numbers of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regionshospital Nordjylland
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dorte Melgaard Kristiansen, Regionshospital Nordjylland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03426800
- Sponsor's protocol ID
- RHN_DMK_01
- Status last verified
- Nov 2018
- First submitted
- 25 Jan 2018
- Last updated
- 28 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture - a Treatment for Children With Headache
- ClinicalTrials.gov ID
- NCT03426800
- Acronym / sponsor ID
- RHN_DMK_01
- Conditions
- Headache
- Keywords
- Acupuncture, Training, Children, Effect
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Limited numbers of patients
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Regionshospital NordjyllandOther government
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 6 Nov 2018 (actual)
- Study completion
- 6 Nov 2018 (actual)
- First posted
- 8 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Migraine_acupuncture and training | Experimental | Other: Acupuncture and trainingMigraine acupuncture and training |
| Migraine training | Experimental | Other: Acupuncture and trainingMigraine training |
| Tension_acupuncture and training | Experimental | Other: Acupuncture and trainingTension headache acupuncture and training |
| Tension headache training | Experimental | Other: Acupuncture and trainingTension headache training |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnosed by pediatrician-
- Age-9-17 years
- Min. headache 8 times within the last month
Key exclusion criteria (2 listed)
- Mentally illness
- Fear of needles
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture and trainingAcupuncture twice in the week in 3 weeks combined with training in 6 weeks | Other | Migraine training, Migraine_acupuncture and training, Tension headache training, Tension_acupuncture and training |
Primary outcome
Days with headache
Time frame: 30 days
Number of days with headache
Results and safety
The study was stopped early (reason given: Limited numbers of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture and training in people with Headache, run by Regionshospital Nordjylland at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Limited numbers of patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days with headache (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2018.