Home » Trials » SLCTR/2017/018
Effectiveness of para nasalsinus air suction in the treatment of acute migraine headache - A randomized, double-blind, placebo-controlled Study
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SLCTR Registration Number
SLCTR/2017/018
Date of Registration
The date of last modification
Jun 30, 2020
Trial Status
Scientific Title of Trial
Effectiveness of para nasalsinus air suction in the treatment of acute migraine headache - A randomized, double-blind, placebo-controlled Study
Public Title of Trial
Nasal air suction in the treatment of acute migraine headache
Disease or Health Condition(s) Studied
Migraine
Scientific Acronym
None
Public Acronym
None
Brief title
Effectiveness of para nasalsinus air suction in the treatment of acute migraine headache
Universal Trial Number
U1111-1190-2358
Any other number(s) assigned to the trial and issuing authority
38/2016 (ERC:Medical Research Institute, Sri Lanka)
What is the research question being addressed?
What is the efficacy of paranasal sinus air suction compared to a placebo device in the treatment of acute migraine in school children aged 16-19 years?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Applicable
Intervention(s) planned
The study will be carried out among school children in the Kandy District.
Participant allocation will be through stratified block randomization. A total of 12 schools will be selected using simple randomization. Participants in each school will be allocated into the intervention and control arms using block randomization (block size=4).
The intervention arm will receive nasal air suction for a period of 60 seconds with 10 seconds interval to each nostril. This will be delivered by a Compact High Suction Unit SUC81500 (capacity minimum of 32 liters of free air per minutes and suction,720 mmHg against a barometer of 760mmHg).
The control arm will receive placement of an identical placebo device without air suction a period of 60 seconds with 10 seconds interval to each nostril. The appearance of the nasal air mask and the sound of air suction will be indistinguishable from the active device.
The participants will be given standard treatment for migraine with their usual rescue pain medication and anti-emetics following application of the device. Additional medical therapy for acute migraine attacks (e.g. sumatriptan, aspirin, ibuprofen, paracetamol and domperidone) will be made available with qualified medical officers at the intervention site.
Participants and outcome assessors will be blinded to the intervention.
Inclusion criteria
Male and female school children
Age 16-19 years
Diagnosed with migraine according to the IHS-criteria ICHD-II 1.1: Migraine without aura [G43.0] 1.2: Migraine with aura [G43.1]
Complaint of a single migraine headache of moderate or severe intensity
Exclusion criteria
History of cranial lesion or tumor
Recent nasal or sinus infective illness, trauma and runny nose
Smoking
Known to abuse alcohol or drugs
Females on hormonal therapy for any condition or illness
Diagnosed psychiatric illness
Any other acute or chronic illness
Participants on non-medical/non-nutritional treatment for migraine prevention such as acupuncture or psychotherapy.
Participants on current medical treatment for acute migraine or migraine prophylaxis
Non-provision of informed consent and/or having lack of understanding of the information regarding the study
Primary outcome(s)
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1.
Headache relief (defined as reduction of headache pain intensity from severe or moderate migraine headache to mild or none) at 60 seconds post-application of the device - using a 10 point pain scale and a 4 point Glaxo visual analogue scale. |
[ At 60 seconds post-application of the device and at the completion of 1, 2, 4, 6, 12 and 24 hours post–application of the device ] |
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2.
Change in severity of suborbital tenderness/ scalp tenderness due to migraine headache - - using a 10 point pain scale and a 4 point Glaxo visual analogue scale. |
[ At 60 seconds post-application of the device and at the completion of 1, 2, 4, 6, 12 and 24 hours post–application of the device ] |
Secondary outcome(s)
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1.
None |
[ None ] |
Target number/sample size
46 (23 in each arm)
Countries of recruitment
Anticipated start date
2016-07-04
Anticipated end date
2017-12-30
Date of first enrollment
2017-06-29
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
None (Investigator funded)
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2017-01-10
Approval number
38/2016
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Medical Research Institute, Ministry of Health |
| Institutional Address: | P.O. Box 527, Dr Danister De Silva Mawatha (Baseline Road), Colombo 00800 Sri Lanka |
| Telephone: | +94-11-2693532 (Extension: 353) |
| Email: | erc_mri2016@hotmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. S.M. Rathnasiri Bandara
Medical Officer
Neurology Unit,
Teaching Hospital Kandy,
Kandy, Sri Lanka
Tel: 0823233341
Mob: 0714453646
rathnasirib68@gmail.com
Contact Person for Public Queries
Dr. D.M.P.U.K. Ralapanawa
Consultant Physician and Senior Lecturer
Department of Medicine
Faculty of Medicine, University of Peradeniya
Sri Lanka
Tel: 0812389106
Mob: 0718495682
udayapralapanawa@yahoo.com, udayaralapanawa@pdn.ac.lk
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Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
