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

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Efficacy of the Osteo-Fluidic-sensitive (OFS) Versus Placebo Method in the Management of Frequent Episodic Tension-type Headache. Pilot Study.

Conditions
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Tension-Type Headache Episodic

Intervention / Treatment
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* Other: Osteo fluidic Sensitive méthod
* Other: Placebo method


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Osteo-Fluidic-Sensitive method<br> | Other: Osteo fluidic Sensitive méthod<br>* Manual therapy, without manipulative treatment, based on rebalancing of the body with manual pressures on specific body areas.<br>|
| Placebo Comparator: Placebo method<br> | Other: Placebo method<br>* Soft Manual pressures at specific points that are defined as non-effective and non-deleterious for patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| numbers of days with headaches | The main criteria for the study will be the difference of the number of days with headaches evaluated based on a calendar of headaches between the month prior to the beginning of the treatment and the month following the last session (1st month). | one month |