Pilot Study of the Osteo-Fluidic-Sensitive (OFS) in Tension-type Headache.
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Osteo-Fluidic-Sensitive method
|
Other: Osteo fluidic Sensitive méthod
Manual therapy, without manipulative treatment, based on rebalancing of the body with manual pressures on specific body areas.
|
| Placebo Comparator: Placebo method
|
Other: Placebo method
Soft Manual pressures at specific points that are defined as non-effective and non-deleterious for patients.
|
Outcome Measures
Primary Outcome Measures
- 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).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
18 and 60 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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Poitiers University Hospital
Investigators
- Principal Investigator: Helene KERSUZAN, CHU de Poitiers FRANCE
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CephalOFS