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Recruiting Not applicable

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

NCT05229224 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2022-11-29
Last updated
2026-01-06

Condition(s) studied

Tension-Type Headache Episodic

Investigational drug(s) / intervention(s)

Osteo fluidic Sensitive méthodPlacebo method

Osteo fluidic Sensitive méthod: Manual therapy, without manipulative treatment, based on rebalancing of the body with manual pressures on specific body areas.

Placebo method: Soft Manual pressures at specific points that are defined as non-effective and non-deleterious for patients.

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • numbers of days with headaches — one month
    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).

Trial sites (1)

FacilityCityRegionStatus
CHU Poitiers Poitiers France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05229224 on ClinicalTrials.gov ↗ ← All trials in France