Tension-Type HeadacheNCT05906901
Effects of Osteopathic Treatment in Patients With Tension Type Headache
A study testing Cranial listening technique and Suboccipital muscles inhibition technique in people with Tension-Type Headache, run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.
Trial summary
The aim of this study is to evaluate the effects of the suboccipital muscles inhibition technique on patients suffering from tension-type headaches. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tension-Type Headache
- What is being tested?
- Cranial listening technique and Suboccipital muscles inhibition technique
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 sitePortugal
- Study dates
- Sep 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- They must have tension-type headache, that is, a headache with:
- a duration of at least 30 min to days, with or without an break;
- must have at least two of the following four characteristics:
- bilateral location
- pressure or squeezing quality (non throbbing)
- weak or moderate intensity
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- not aggravated by routine physical activity such as walking or climbing stairs;
- must have both of the following criteria:
- only one of the following: photophobia, phonophobia, or mild nausea
- absence of moderate or severe nausea or vomiting.
Who cannot join
- They can't be on antibiotics, antivirals, or antidepressants;
- They can't have neurological problems;
- They shouldn't have any absolute contraindication for the osteopathic maneuvers;
- They can't have acute pathologies (ex: infection) or serious (ex: cancer);
- They can't have fractures in the skull, cervical spine or high dorsal spine (up to D4);
- They can't be pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate the effects of the suboccipital muscles inhibition technique on patients suffering from tension-type headaches.
Read the detailed description
The tension-type headache is a recurrent condition with a high financial repercussion in Portugal. Their side effects often impact daily activities, reducing the quality of life of the patients.
In several studies, the excessive tension of the suboccipital muscles are usually referred as a cause of tension-type headache, since they can exert tension on the dura mater through the myodural bridge.
- Conditions
- Tension-Type Headache
- Being tested
- Cranial listening technique, Suboccipital muscles inhibition technique
- Medical subject headings
- Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranial listening techniqueOther
5 minutes
Suboccipital muscles inhibition techniqueOther
6 minutes
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | The investigator will perform a cranial listening technique. Receives: Other: Cranial listening technique |
| Suboccipital muscles inhibition | Experimental | The investigator will perform a suboccipital muscles inhibition technique. Receives: Other: Suboccipital muscles inhibition technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency
Measured by monthly counting.
Measured: One month after first intervention
Intensity
Measured by visual analogue scale (VAS). It goes from 0 to 10, 0 being the minimum pain intensity and 10 the maximum pain intensity.
Measured: One month after first intervention
Impact on quality of life questionnaire
Measured by questionnaire. The questionnaire attribuates a score after answering six questions. The lowest score a participant can obtain is 36, which corresponds to the lowest impact on quality of life. The highest score a participant can obtain is 78, which corresponds to the highest impact on quality of life.
Measured: one month after first intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study startSep 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tension-Type HeadacheStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natália Maria Oliveira Campelo, Escola Superior de Tecnologia da Saúde do Porto
- Investigators
- Natália MO Natália, Principal investigator, Escola Superior da Saúde do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05906901
- Sponsor's protocol ID
- OST1-009
- Status last verified
- Apr 2024
- First submitted
- 2 Jun 2023
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. No abstract available.
PubMed 23771276
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Osteopathic Treatment in Patients With Tension Type Headache
- ClinicalTrials.gov ID
- NCT05906901
- Acronym / sponsor ID
- OST1-009
- Conditions
- Tension-Type Headache
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do PortoUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Jun 2023 (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 aim of this study is to evaluate the effects of the suboccipital muscles inhibition technique on patients suffering from tension-type headaches.
Detailed description
The tension-type headache is a recurrent condition with a high financial repercussion in Portugal. Their side effects often impact daily activities, reducing the quality of life of the patients.
In several studies, the excessive tension of the suboccipital muscles are usually referred as a cause of tension-type headache, since they can exert tension on the dura mater through the myodural bridge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Other: Cranial listening techniqueThe investigator will perform a cranial listening technique. |
| Suboccipital muscles inhibition | Experimental | Other: Suboccipital muscles inhibition techniqueThe investigator will perform a suboccipital muscles inhibition technique. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- a duration of at least 30 min to days, with or without an break;
- must have at least two of the following four characteristics:
- must have both of the following criteria:
Key exclusion criteria (6 listed)
- They can't be on antibiotics, antivirals, or antidepressants;
- They can't have neurological problems;
- They shouldn't have any absolute contraindication for the osteopathic maneuvers;
- They can't have acute pathologies (ex: infection) or serious (ex: cancer);
- They can't have fractures in the skull, cervical spine or high dorsal spine (up to D4);
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 |
|---|---|---|
| Cranial listening technique5 minutes | Other | Control Group |
| Suboccipital muscles inhibition technique6 minutes | Other | Suboccipital muscles inhibition |
Primary outcome
Frequency
Time frame: One month after first intervention
Measured by monthly counting.
Intensity
Time frame: One month after first intervention
Measured by visual analogue scale (VAS). It goes from 0 to 10, 0 being the minimum pain intensity and 10 the maximum pain intensity.
Impact on quality of life questionnaire
Time frame: one month after first intervention
Measured by questionnaire. The questionnaire attribuates a score after answering six questions. The lowest score a participant can obtain is 36, which corresponds to the lowest impact on quality of life. The highest score a participant can obtain is 78, which corresponds to the highest impact on quality of life.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Results publication: PubMed 23771276Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition (beta version). Cephalalgia. 2013 Jul;33(9):629-808. doi: 10.1177/0333102413485658. No abstract available.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Natália MO Natália principal investigator
Escola Superior da Saúde do Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cranial listening technique and Suboccipital muscles inhibition technique in people with Tension-Type Headache, run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.
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 10 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 8 Apr 2024. 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 Portugal. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natália MO Campelo, PhD (351 22 206 1000, nmc@ess.ipp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency (time frame: One month after first intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05906901, which also lists 1 linked publication.
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 8 Apr 2024.