Pilot Study of the Osteo-Fluidic-Sensitive (OFS) in Tension-type Headache.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Osteo fluidic Sensitive méthod, Placebo method.
- Who it may be relevant to
- Registry conditions: Tension-Type Headache Episodic. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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.
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.
Interventions
- Other Osteo fluidic Sensitive méthod
Manual therapy, without manipulative treatment, based on rebalancing of the body with manual pressures on specific body areas. - Other Placebo method
Soft Manual pressures at specific points that are defined as non-effective and non-deleterious for patients.
Primary outcome measures
- numbers of days with headaches [Time frame: one month]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
France · 1 center
- CHU Poitiers — Poitiers
Identifiers
NCT: NCT05229224 · CephalOFS