Pilot Study of the Osteo-Fluidic-Sensitive (OFS) in Tension-type Headache.

Poitiers University Hospital

Status: Enrolling

Conditions: Tension-Type Headache Episodic

Treatments: Other: Placebo method; Other: Osteo fluidic Sensitive méthod

Study type: Interventional

Funder types: Other

Identifiers

NCT05229224

CephalOFS

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Osteo-Fluidic-Sensitive method

Experimental group

Treatment:

Other: Osteo fluidic Sensitive méthod

Placebo method

Placebo Comparator group

Treatment:

Other: Placebo method