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 -

SLCTR Registration Number

SLCTR/2017/018


Date of Registration

29 Jun 2017

The date of last modification

Jun 29, 2017



Application Summary


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 of 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 Trail Number

U1111-1190-2358


Any other number(s) assigned to the trial and issuing authority

38/2016 (ERC:Medical Research Institute, Sri Lanka)


Trial Details


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


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

  1. Male and female school children

  2. Age 16-19 years

  3. Diagnosed with migraine according to the IHS-criteria ICHD-II 1.1: Migraine without aura [G43.0] 1.2: Migraine with aura [G43.1]

  4. Complaint of a single migraine headache of moderate or severe intensity


Exclusion criteria

  1. History of cranial lesion or tumor

  2. Recent nasal or sinus infective illness, trauma and runny nose

  3. Smoking

  4. Known to abuse alcohol or drugs

  5. Females on hormonal therapy for any condition or illness

  6. Diagnosed psychiatric illness

  7. Any other acute or chronic illness

  8. Participants on non-medical/non-nutritional treatment for migraine prevention such as acupuncture or psychotherapy.

  9. Participants on current medical treatment for acute migraine or migraine prophylaxis

  10. Non-provision of informed consent and/or having lack of understanding of the information regarding the study



Primary outcome(s)

  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.

  2. Change in severity of suborbital tenderness/ scalp tenderness due to migraine headache

The above will be measured using a 10 point pain scale and a 4 point Glaxo visual analogue scale.


Primary outcome(s) - Time of assessment(s)

  1. 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

None


Secondary outcome(s) - Time of assessment(s)

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


Recruitment status

Pending


State of ethics review approval

Approved by the Research Committee of the Medical Research Institute on 10th January 2017 (Ref. 38/2016)


Funding source

None (Investigator funded)



Contact & Sponsor Information


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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Primary study sponsor/organization

Dr. S.M. Rathnasiri Bandara
Medical Officer
Neurology Unit, Teaching Hospital Kandy, Kandy, Sri Lanka



Secondary study sponsor (If any)

None