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NCT Number: NCT05229224

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

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.

Recruiting

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Key information

Conditions

Tension-Type Headache Episodic

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Osteo fluidic Sensitive méthod

Other

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

Placebo method

Other

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

Primary outcomes

  1. numbers of days with headaches

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Helene KERSUZAN

CONTACT

[email protected]

+33549443961

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 8, 2022
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.