Tension-Type Headache EpisodicNCT05229224
Pilot Study of the Osteo-Fluidic-Sensitive (OFS) in Tension-type Headache.
A study testing Osteo fluidic Sensitive méthod in people with Tension-Type Headache Episodic, run by Poitiers University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Tension-Type Headache Episodic
- What is being tested?
- Osteo fluidic Sensitive méthod
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 29 Nov 2022to 29 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Poitiers
Poitiers, 86000
Hélène KERSUZAN, +33543443961, helene.kersuzan@chu-poitiers.fr
About this study
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.
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
- Being tested
- Osteo fluidic Sensitive méthod, Placebo method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteo fluidic Sensitive méthodOther
Manual therapy, without manipulative treatment, based on rebalancing of the body with manual pressures on specific body areas.
Placebo methodOther
Soft Manual pressures at specific points that are defined as non-effective and non-deleterious for patients.
| Study group | Role | What they receive |
|---|---|---|
| Osteo-Fluidic-Sensitive method | Experimental | Not described Receives: Other: Osteo fluidic Sensitive méthod |
| Placebo method | Placebo comparator | Not described Receives: Other: Placebo method |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start29 Nov 2022
- Primary completion29 May 2026 (estimated)
- Study completion29 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tension-Type Headache EpisodicStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helene KERSUZAN, Principal investigator, CHU de Poitiers FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05229224
- Sponsor's protocol ID
- CephalOFS
- Status last verified
- Jan 2025
- First submitted
- 26 Jan 2022
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05229224
- Acronym / sponsor ID
- CephalOFS
- Conditions
- Tension-Type Headache Episodic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 29 Nov 2022 (actual)
- Primary completion
- 29 May 2026 (estimated)
- Study completion
- 29 Aug 2026 (estimated)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteo-Fluidic-Sensitive method | Experimental | Other: Osteo fluidic Sensitive méthod |
| Placebo method | Placebo comparator | Other: Placebo method |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteo fluidic Sensitive méthodManual therapy, without manipulative treatment, based on rebalancing of the body with manual pressures on specific body areas. | Other | Osteo-Fluidic-Sensitive method |
| Placebo methodSoft Manual pressures at specific points that are defined as non-effective and non-deleterious for patients. | Other | Placebo method |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Helene KERSUZAN principal investigator
CHU de Poitiers FRANCE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteo fluidic Sensitive méthod in people with Tension-Type Headache Episodic, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Helene KERSUZAN (+33549443961, helene.kersuzan@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
numbers of days with headaches (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.