Migraine
Conditions
Keywords
Migraine, Toothpaste, Kindling, Lifestyle intervention
Brief summary
Certain ingredients in toothpaste have the potential to cause headache. In this clinical trial, we will be replacing toothpaste with saline water in a group of persons with migraine and compare them with another group of persons with migraine who will continue the use of toothpaste. Both the groups will have the same treatment protocol with the only difference being the intervention of changing the toothpaste with saline. This study will show whether this lifestyle intervention can improve headache frequency in persons with migraine over a four week period.
Detailed description
Migraine headaches affect approximately 40% of the population and is one of the most prevalent and disabling neurological disorders worldwide. Although there are currently several medications available for the prevention of migraine attacks a majority of patients, with chronic and episodic migraines have experienced treatment failure, which greatly affects their personal, social and professional lives. Commonly used migraine preventive therapies such as topiramate, propranolol, amitriptyline and valproate may have unacceptable side effects leading to poor adherence. Few recent papers have implicated substances in toothpaste to trigger headache attacks. Multiple ingredients in commonly used toothpaste such as nitrates, fluorides, benzoate, sorbitol, eucalyptol, camphor, etc., have the potential to cause headaches. In this randomized physician-blinded controlled pilot exploratory study, we report the impact of toothpaste cessation on headache frequency and severity in patients with migraine headaches (PwM).
Interventions
OTHERToothpaste Cessation
The participants randomised to the intervention group will be asked to replace toothpaste with normal saline (0.9%) to brush their teeth. They will be advised not to use toothpowder, neem sticks or any other alternative dentifrices.
Sponsors
St.John's National Academy of Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No
Inclusion criteria
* Adults 18-59 years of age who had migraine with or without aura and who were not on any prophylactic medicines will be enrolled for participation in the study. Migraine is defined in accordance with the International Classification of Headache Disorders, 3rd Edition (ICHD3).
Exclusion criteria
* Patients with a history of hemiplegic migraine, cluster headache, and other trigeminal autonomic cephalalgias, and secondary headaches will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Headache frequency | 4 weeks | The primary outcome of the study is to assess the change in the mean number of headache days from baseline to the fourth week. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Headache Severity | 4 weeks | Secondary outcomes are change in headache severity on a numerical rating scale of 0-10 (0 - no pain, 10 - worst pain), proportion of patients with complete pain freedom, proportion of patients with more than 50% headache reduction in mean number of headache days. |
Countries
India
Outcome results
None listed