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

Primary Purpose

Tension-Type Headache Episodic

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Osteo fluidic Sensitive méthod
Placebo method
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tension-Type Headache Episodic

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU PoitiersRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Osteo-Fluidic-Sensitive method

Placebo method

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
January 26, 2022
Last Updated
April 26, 2023
Sponsor
Poitiers University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05229224
Brief Title
Pilot Study of the Osteo-Fluidic-Sensitive (OFS) in Tension-type Headache.
Official Title
Evaluation of the Efficacy of the Osteo-Fluidic-sensitive (OFS) Versus Placebo Method in the Management of Frequent Episodic Tension-type Headache. Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 29, 2022 (Actual)
Primary Completion Date
June 29, 2024 (Anticipated)
Study Completion Date
July 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tension-Type Headache Episodic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Osteo-Fluidic-Sensitive method
Arm Type
Experimental
Arm Title
Placebo method
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Osteo fluidic Sensitive méthod
Intervention Description
Manual therapy, without manipulative treatment, based on rebalancing of the body with manual pressures on specific body areas.
Intervention Type
Other
Intervention Name(s)
Placebo method
Intervention Description
Soft Manual pressures at specific points that are defined as non-effective and non-deleterious for patients.
Primary Outcome Measure Information:
Title
numbers of days with headaches
Description
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).
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Helene KERSUZAN
Phone
+33549443961
Email
helene.kersuzan@chu-poitiers.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helene KERSUZAN
Organizational Affiliation
CHU de Poitiers FRANCE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hélène KERSUZAN
Phone
+33543443961
Email
helene.kersuzan@chu-poitiers.fr

12. IPD Sharing Statement

Learn more about this trial

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

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