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

Poitiers University Hospital30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Tension-Type Headache Episodic

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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).

Time frame: one month