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

Not Applicable

Recruiting

• Conditions: Tension-Type Headache Episodic
• Interventions: Other: Osteo fluidic Sensitive méthod; Other: Placebo method

• Registration Number: NCT05229224
• Lead Sponsor: Poitiers University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-26
• Study First Submitted QC: 2022-02-07
• Study First Posted: 2022-02-08
• Study Start: 2022-11-29
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-27
• Primary Completion: 2024-06-29
• Study Completion: 2024-07-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Osteo-Fluidic-Sensitive method	Osteo fluidic Sensitive méthod	-
Placebo method	Placebo method	-

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

CHU Poitiers; 🇫🇷 Poitiers, France