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

NCT ID: NCT05229224

Last Updated: 2026-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-29

Study Completion Date

2026-08-29

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.

Detailed Description

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Conditions

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Tension-Type Headache Episodic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Osteo-Fluidic-Sensitive method

Group Type EXPERIMENTAL

Osteo fluidic Sensitive méthod

Intervention Type OTHER

Manual therapy, without manipulative treatment, based on rebalancing of the body with manual pressures on specific body areas.

Placebo method

Group Type PLACEBO_COMPARATOR

Placebo method

Intervention Type OTHER

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

Interventions

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Osteo fluidic Sensitive méthod

Manual therapy, without manipulative treatment, based on rebalancing of the body with manual pressures on specific body areas.

Intervention Type OTHER

Placebo method

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

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Helene KERSUZAN

Role: PRINCIPAL_INVESTIGATOR

CHU de Poitiers FRANCE

Locations

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CHU Poitiers

Poitiers, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Helene KERSUZAN

Role: CONTACT

+33549443961

Facility Contacts

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Hélène KERSUZAN

Role: primary

+33543443961

Other Identifiers

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CephalOFS

Identifier Type: -

Identifier Source: org_study_id

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