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

NCT05229224 | Recruiting

• 1 other identifier: CephalOFS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Tension-Type Headache Episodic

Outcome Measures

Primary Outcomes (1)

• numbers of days with headaches

  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).

  one month

Study Arms (2)

Osteo-Fluidic-Sensitive method

EXPERIMENTAL

Other: Osteo fluidic Sensitive méthod

Placebo method

PLACEBO COMPARATOR

Other: Placebo method

Interventions

Osteo fluidic Sensitive méthod OTHER

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

Osteo-Fluidic-Sensitive method

Placebo method OTHER

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

Placebo method

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

CHU Poitiers

Poitiers, 86000, France

RECRUITING

Study Officials

• Helene KERSUZAN

  CHU de Poitiers FRANCE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helene KERSUZAN

CONTACT

+33549443961; helene.kersuzan@chu-poitiers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: February 8, 2022
• Study Start: November 29, 2022
• Primary Completion: May 29, 2026
• Study Completion (Estimated): August 29, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-01

Locations

FR (1)