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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05229224
Enrollment
30
Registered
2022-02-08
Start date
2022-11-29
Completion date
2026-08-29
Last updated
2026-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tension-Type Headache Episodic

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.

Interventions

OTHEROsteo fluidic Sensitive méthod

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

OTHERPlacebo method

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

Sponsors

Poitiers University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
numbers of days with headachesone monthThe 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).

Countries

France

Contacts

Primary ContactHelene KERSUZAN
helene.kersuzan@chu-poitiers.fr+33549443961

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026