Osteo-Fluidic-Sensitive (OFS) method for frequent tension-type headache
Evaluation of the Efficacy of the Osteo-Fluidic-sensitive (OFS) Versus Placebo Method in the Management of Frequent Episodic Tension-type Headache. Pilot Study.
This study will test whether the Osteo-Fluidic-Sensitive (OFS) method can reduce the number of headache days per month in adults with frequent episodic tension-type headache.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Poitiers University Hospital Academic / other |
| Locations | 1 site (Poitiers) |
| Trial ID | NCT05229224 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults 18–75 years old with highly frequent episodic tension-type headache (2–14 headache days per month) who completed a headache diary and can give informed consent are ideal candidates.
Not a fit: People with chronic tension-type headache, migraine-only disorders, cluster headaches, neuralgias, those on excluded medications (e.g., venlafaxine, gabapentin, duloxetine, clomipramine, botulinum toxin), pregnant or breastfeeding women, and those unable to attend the center are unlikely to benefit from participation.
Why it matters
Potential benefit: If effective, OFS could reduce monthly headache days, improve quality of life, and lower the need for acute headache medications.
How similar studies have performed: This specific OFS method appears novel and has not been widely tested in controlled trials, while related manual and osteopathic approaches have produced mixed results in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Poitiers
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.