Osteo-Fluidic-Sensitive (OFS) method for frequent tension-type headache

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with frequent episodic tension-type headache (2–14 days per month) will be enrolled at CHU Poitiers and receive either the OFS method or a placebo (sham) procedure. Participants will complete a headache diary before and during the 3-month treatment period to measure change in the number of headache days per month. Secondary outcomes include quality of life measures and use of rescue medications. The trial is a pilot, single-center, placebo-controlled interventional comparison to estimate effect size and feasibility.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 18 and 75 years' old
* Person having highly frequent episodic tension type headache (between 2 and 14 days of headaches per month) associated or not to headache with characteristic of a migraine per International Classification of Headache Disorders 3rd edition criteria
* Person who completed his headache agenda the month before the study.
* Patient who understands and accepts the effects of the study
* Signed consent
* Person with health insurance coverage

Exclusion Criteria:

* Person having secondary or primary headaches (chronic tension type headache, migraines only, Cluster headaches, Neuralgias ...)
* Person on treatment of venlafaxine, gabapentine, duloxetine, clomipramine et toxine botulique.
* Concomitant participation to another clinical research
* Pregnant or lactating women, women of child-bearing age who do not have effective contraception.
* People with reinforced protection (juvenile), people deprived of liberty per justice or administrative decision, people living in a sanitary and social establishment, adults under legal protection and people in critical medical conditions

Where it's running

• CHU Poitiers
  Poitiers, France Recruiting

Study contacts

• Principal investigator: Helene KERSUZAN — CHU de Poitiers FRANCE
• Study coordinator: Helene KERSUZAN
• Email: helene.kersuzan@chu-poitiers.fr
• Phone: +33549443961

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.