Oxygen Therapy for Headache

Primary Headache Disorder Clinical Trial

Official title:

Efficacy of Oxygen Therapy in Primary Headache Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05511155
• Other study ID #: 64-SBKAEK
• Status: Completed
• Start date: July 1, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: September 2022
• Source: Aksaray University Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: September 30, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Headache Disorders
• Headache Disorders, Primary
• Primary Headache Disorder

Intervention

Other:
• Oxygen therapy
Oxygen therapy will be given for 15 minutes with a non-rebreathing mask.

Locations

Country	Name	City	State
Turkey	Aksaray University Aksaray Training and Research Hospital	Aksaray

Sponsors (1)

Lead Sponsor	Collaborator
Aksaray University Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

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