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

April 26, 2023 updated by: Poitiers University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
numbers of days with headaches
Time Frame: 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).
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Investigators

  • Principal Investigator: Helene KERSUZAN, CHU de Poitiers FRANCE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2022

Primary Completion (Anticipated)

June 29, 2024

Study Completion (Anticipated)

July 29, 2024

Study Registration Dates

First Submitted

January 26, 2022

First Submitted That Met QC Criteria

February 7, 2022

First Posted (Actual)

February 8, 2022

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CephalOFS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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