Oxygen Therapy for Headache

Efficacy of Oxygen Therapy in Primary Headache Disorder

Headache is one of the common causes of emergency department admissions and constitutes approximately 2%. Although the exact mechanism is not clear, It is known that high-flow oxygen therapy is effective in headache treatment. There are limited studies related to the use of oxygen therapy in headaches and its derivatives in the literature. In this study, the investigators aimed to compare the high and medium flow oxygen therapies with placebo in primary headache disorders.

Study Overview

• Status: Completed
• Conditions: Primary Headache Disorder
• Intervention / Treatment: Other: Oxygen therapy

Detailed Description

Four different treatment methods were determined; 1) high-flow oxygen (15lt/min oxygen), 2) medium-flow oxygen (8lt/min oxygen), 3) high-flow room air as placebo (15 lt/min room air), 4) medium-flow room air as placebo (8 lt/min room air). All four treatment methods will be applied to all patients included in the study. One of the four treatments will be randomly applied at each separate ED admission with a gap of 1 week or more in between. This randomization will be performed by a computer at the time of admission. A study nurse will administer the patient's therapy according to the computer's current decision for 15 minutes. Patients and treating physicians will be blinded to the selected therapy. After 15 minutes of the end of treatment (at the 30th minute of the start of treatment), the treating physician will ask patients if they need rescue analgesia and analgesia will be administered if necessary. Additional analgesia is at the discretion of the treating physician. Patient data, including demographics, medical history, and findings of a physical examination performed before and after therapy will be recorded by the treating physician.

• Study Type: Observational
• Enrollment (Actual): 132

Contacts and Locations

Study Locations

• Turkey
  • Aksaray, Turkey, 68200
    • Aksaray University Aksaray Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

all patients had one to six headache attacks per month which were started before 50 years old and were present for more than one year.

Description

Inclusion Criteria:

• age 18-55 years
• frequent attacks of primary headache disorders according to International Headache Society (IHS) criteria

Exclusion Criteria:

• secondary headache disorders
• oxygen-dependent chronic illnesses such as chronic obstructive pulmonary disease
• a history of cerebrovascular disease
• pregnancy
• active smokers or living with a smoker.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
O-15; 15 lt/min oxygen	Other: Oxygen therapy; Oxygen therapy will be given for 15 minutes with a non-rebreathing mask.
O-8; 8 lt/min oxygen	Other: Oxygen therapy; Oxygen therapy will be given for 15 minutes with a non-rebreathing mask.
A-15; 15 lt/min room air	Other: Oxygen therapy; Oxygen therapy will be given for 15 minutes with a non-rebreathing mask.
A-8; 8 lt/min room air	Other: Oxygen therapy; Oxygen therapy will be given for 15 minutes with a non-rebreathing mask.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analog scale score	primary endpoint is the relative reduction in visual analog scale (a psychometric response scale) score in the placebo versus oxygen group to determine whether there was a difference between the high-flow and mid-flow therapies. visual analog scale scaled from 0-100 points with 0 meaning "no pain" and 100 points meaning "worst possible pain".	0-60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rescue analgesia	rescue analgesia (yes/no)	30 th minutes
length of stay	length of stay in the emergency department (time in minutes)	0-300 minutes
duration of a pain	duration of a pain attack (time in minutes)	0-300 minutes
readmission	readmission to the emergency department within 7 days (yes/no)	0-7 days

Collaborators and Investigators

• Sponsor: Aksaray University Training and Research Hospital

Publications and helpful links

General Publications

• Friedman BW, Grosberg BM. Diagnosis and management of the primary headache disorders in the emergency department setting. Emerg Med Clin North Am. 2009 Feb;27(1):71-87, viii. doi: 10.1016/j.emc.2008.09.005.
• Roberto G, Raschi E, Piccinni C, Conti V, Vignatelli L, D'Alessandro R, De Ponti F, Poluzzi E. Adverse cardiovascular events associated with triptans and ergotamines for treatment of migraine: systematic review of observational studies. Cephalalgia. 2015 Feb;35(2):118-31. doi: 10.1177/0333102414550416. Epub 2014 Sep 22.
• Mo H, Chung SJ, Rozen TD, Cho SJ. Oxygen Therapy in Cluster Headache, Migraine, and Other Headache Disorders. J Clin Neurol. 2022 May;18(3):271-279. doi: 10.3988/jcn.2022.18.3.271.
• Petersen AS, Barloese MC, Lund NL, Jensen RH. Oxygen therapy for cluster headache. A mask comparison trial. A single-blinded, placebo-controlled, crossover study. Cephalalgia. 2017 Mar;37(3):214-224. doi: 10.1177/0333102416637817. Epub 2016 Jul 11.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: August 16, 2022
• First Submitted That Met QC Criteria: August 19, 2022
• First Posted (Actual): August 22, 2022

Study Record Updates

• Last Update Posted (Actual): October 4, 2022
• Last Update Submitted That Met QC Criteria: September 30, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: emergency department; migraine; oxygen therapy; cluster type headache
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache; Headache Disorders; Headache Disorders, Primary
• Other Study ID Numbers: 64-SBKAEK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No