NCT05229224 Pilot Study of the Osteo-Fluidic-Sensitive (OFS) in Tension-type Headache.
| NCT ID | NCT05229224 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Poitiers University Hospital |
| Condition | Tension-Type Headache Episodic |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2022-11-29 |
| Primary Completion | 2026-05-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2022-11-29 with a primary completion date of 2026-05-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The hypothesis of the study is the Osteo-fluidic-Senstive is effective for lowering headache pains (Reduction of the number of days of headaches per month) for patients having frequent episodic tension-type headache. The OFS method will improve quality of life and will reduce the consumption of crisis treatments. Compare the efficacy of the Osteo-Fluidic-Sensitive method versus a placebo method on patients with tension type headache for the reduction of the number of days of headaches per month after 3 months of treatment at Centre Hospitalier Universitaire de Poitiers.
Eligibility 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
Contact & Investigator
Helene KERSUZAN
PRINCIPAL INVESTIGATOR
CHU de Poitiers FRANCE
Frequently Asked Questions
Who can join the NCT05229224 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Tension-Type Headache Episodic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05229224 currently recruiting?
Yes, NCT05229224 is actively recruiting participants. Contact the research team at helene.kersuzan@chu-poitiers.fr for enrollment information.
Where is the NCT05229224 trial being conducted?
This trial is being conducted at Poitiers, France.
Who is sponsoring the NCT05229224 clinical trial?
NCT05229224 is sponsored by Poitiers University Hospital. The principal investigator is Helene KERSUZAN at CHU de Poitiers FRANCE. The trial plans to enroll 30 participants.