Tension HeadachesNCT06475248
Influence of Osteopathic Intervention on Cervical Muscles in Tension Headaches in Women
A study testing Stretching technique and Inhibition of the suboccipital in people with Tension Headaches, run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.
Trial summary
This study aims to understand whether there is any relationship between the intervention on the trapezius, sternocleidomastoid and suboccipital muscles in patients with chronic tension headaches. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Tension Headaches
- What is being tested?
- Stretching technique and Inhibition of the suboccipital
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 sitePortugal
- Study dates
- Sep 2026to 11 Dec 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Tension headaches;
- Being over eighteen years of age;
Who cannot join
- Loss of mobility of cervical;
- Cervical and shoulder pain during episodes;
- Other headaches (migraine, cervicogenic headache...)
- Other interventions and/or pharmacological treatment a few days before the intervention;
- Epilepsy;
- Trauma.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site
Escola Superior da Saúde do Porto
Porto, 4200-072
Natália MO Campelo, PhD, 938 674 365 ext. +351, nmc@ess.ipp.pt
About this study
Official title: Influence of Osteopathic Intervention on Cervical Muscles in Tension Headaches in Women: Randomized Controlled Trial
This study aims to understand whether there is any relationship between the intervention on the trapezius, sternocleidomastoid and suboccipital muscles in patients with chronic tension headaches.
Read the detailed description
It is expected to find an improvement in the symptoms and frequency of tension headaches.
In this study, the investigators intend to see the effects of trapezius and sternocleidomastoid "stretching techniques", and "suboccipital inhibition" on tension headaches. To collect data, volunteers were asked to fill out the Headache Impact Test (HIT-6).
- Conditions
- Tension Headaches
- Being tested
- Placebo Technique, Stretching technique, Inhibition of the suboccipital
- Keywords
- Tension headaches, Trapezius Stretching, sternocleidomastoid Stretching, Suboccipital Inhibition, Manual Therapy, Osteopathy, HIT-6
- 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.
Placebo TechniqueOther
For the technique performed in the control group, the researcher will come into contact with the volunteers' chests. This contact will be maintained for the same period of time as the experimental group (6 minutes).
Stretching techniqueOther
"Stretching technique" for the upper trapezius and sternocleidomastoid: the volunteer will be in supine position on the couch, the researcher will perform the technique from the contralateral side of the muscle to be treated, the hand will contact the ipsilateral shoulder to stabilize, meanwhile, with the other hand, contact the upper trapezius and perform a rhythmic pull in contralateral rotation. This technique is performed bilaterally.
Inhibition of the suboccipitalOther
"Inhibition of the suboccipital": the participant is in the supine position, the researcher will position himself behind the patients head. In this technique, contacts will be made on the suboccipital area with the 2nd, 3rd and 4th fingers of both hands. Make a slight pull with your body backwards and wait that there is relaxation of muscular tensions.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Each volunteer selected in this group will complete a scale, in this case Hit-6, to collect data and evaluate the evolution.
Then a placebo technique will be used, which consists of imitating the contacts of the techniques without compressing or pulling the tissue, lasted 6 minutes.
This procedure will be repeated for two more sessions. One month after the first evaluation, the volunteers filled out the Hit-6 scale again. Receives: Other: Placebo Technique |
| Experimental Group | Experimental | After each volunteer completes the Hit-6 scale, one of the researchers will perform the "trapezius and sternocleidomastoid stretching techniques", and "suboccipital inhibition". The techniques performed will only be done once, lasted 6 minutes.
This procedure will be repeated for two more sessions. One month after the first evaluation, the volunteers filled out the Hit-6 scale again. Receives: Other: Stretching technique; Other: Inhibition of the suboccipital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the intensity and frequency of pain after the three treatment sessions;
The scale Hit-6 will be the instrument used to evaluate the level the intensity and frequency of tension headache. This instrument consists of six questions about the characteristics of headaches, with each question presenting five choices. The answers range from never to always. This data will be collected immediately before the first investigation and one month after the first evaluation, through the volunteers filling out the scale.
Measured: One month after the first intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study startSep 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completion11 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tension HeadachesStudies 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
- Outcomes assessor
- Enrolment
- 43 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 Campelo, PhD, Principal investigator, Escola Superior da Saúde do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475248
- Sponsor's protocol ID
- OST1_014
- Status last verified
- Jun 2026
- First submitted
- 20 Jun 2024
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cumplido-Trasmonte C, Fernandez-Gonzalez P, Alguacil-Diego IM, Molina-Rueda F. Manual therapy in adults with tension-type headache: A systematic review. Neurologia (Engl Ed). 2021 Sep;36(7):537-547. doi: 10.1016/j.nrleng.2017.12.005. Epub 2020 Apr 7.
PubMed 34537167Lebedeva ER, Kobzeva NR, Gilev DV, Olesen J. The quality of diagnosis and management of migraine and tension-type headache in three social groups in Russia. Cephalalgia. 2017 Mar;37(3):225-235. doi: 10.1177/0333102416642603. Epub 2016 Jul 11.
PubMed 27053061Hartman, L. S. (2013). Handbook of osteopathic technique. Springer
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Osteopathic Intervention on Cervical Muscles in Tension Headaches in Women: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06475248
- Acronym / sponsor ID
- OST1_014
- Conditions
- Tension Headaches
- Keywords
- Tension headaches, Trapezius Stretching, sternocleidomastoid Stretching, Suboccipital Inhibition, Manual Therapy, Osteopathy, HIT-6
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do PortoUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- 11 Dec 2026 (estimated)
- First posted
- 26 Jun 2024 (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.
This study aims to understand whether there is any relationship between the intervention on the trapezius, sternocleidomastoid and suboccipital muscles in patients with chronic tension headaches.
Detailed description
It is expected to find an improvement in the symptoms and frequency of tension headaches.
In this study, the investigators intend to see the effects of trapezius and sternocleidomastoid "stretching techniques", and "suboccipital inhibition" on tension headaches. To collect data, volunteers were asked to fill out the Headache Impact Test (HIT-6).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Other: Placebo TechniqueEach volunteer selected in this group will complete a scale, in this case Hit-6, to collect data and evaluate the evolution. Then a placebo technique will be used, which consists of imitating the contacts of the techniques without compressing or pulling the tissue, lasted 6 minutes. This procedure will be repeated for two more sessions. One month after the first evaluation, the volunteers filled out the Hit-6 scale again. |
| Experimental Group | Experimental | Other: Stretching technique, Other: Inhibition of the suboccipitalAfter each volunteer completes the Hit-6 scale, one of the researchers will perform the "trapezius and sternocleidomastoid stretching techniques", and "suboccipital inhibition". The techniques performed will only be done once, lasted 6 minutes. This procedure will be repeated for two more sessions. One month after the first evaluation, the volunteers filled out the Hit-6 scale again. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Tension headaches;
- Being over eighteen years of age;
Key exclusion criteria (6 listed)
- Loss of mobility of cervical;
- Cervical and shoulder pain during episodes;
- Other headaches (migraine, cervicogenic headache...)
- Other interventions and/or pharmacological treatment a few days before the intervention;
- Epilepsy;
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 |
|---|---|---|
| Placebo TechniqueFor the technique performed in the control group, the researcher will come into contact with the volunteers' chests. This contact will be maintained for the same period of time as the experimental group (6 minutes). | Other | Control Group |
| Stretching technique"Stretching technique" for the upper trapezius and sternocleidomastoid: the volunteer will be in supine position on the couch, the researcher will perform the technique from the contralateral side of the muscle to be treated, the hand will contact the ipsilateral shoulder to stabilize, meanwhile, with the other hand, contact the upper trapezius and perform a rhythmic pull in contralateral rotation. This technique is performed bilaterally. | Other | Experimental Group |
| Inhibition of the suboccipital"Inhibition of the suboccipital": the participant is in the supine position, the researcher will position himself behind the patients head. In this technique, contacts will be made on the suboccipital area with the 2nd, 3rd and 4th fingers of both hands. Make a slight pull with your body backwards and wait that there is relaxation of muscular tensions. | Other | Experimental Group |
Primary outcome
Change in the intensity and frequency of pain after the three treatment sessions;
Time frame: One month after the first intervention
The scale Hit-6 will be the instrument used to evaluate the level the intensity and frequency of tension headache. This instrument consists of six questions about the characteristics of headaches, with each question presenting five choices. The answers range from never to always. This data will be collected immediately before the first investigation and one month after the first evaluation, through the volunteers filling out the scale.
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 25 Jun 2026.
- Background: PubMed 34537167Cumplido-Trasmonte C, Fernandez-Gonzalez P, Alguacil-Diego IM, Molina-Rueda F. Manual therapy in adults with tension-type headache: A systematic review. Neurologia (Engl Ed). 2021 Sep;36(7):537-547. doi: 10.1016/j.nrleng.2017.12.005. Epub 2020 Apr 7.
- Background: PubMed 27053061Lebedeva ER, Kobzeva NR, Gilev DV, Olesen J. The quality of diagnosis and management of migraine and tension-type headache in three social groups in Russia. Cephalalgia. 2017 Mar;37(3):225-235. doi: 10.1177/0333102416642603. Epub 2016 Jul 11.
- BackgroundHartman, L. S. (2013). Handbook of osteopathic technique. Springer
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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.
Natália MO Campelo, PhD 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 Stretching technique and Inhibition of the suboccipital in people with Tension Headaches, 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 2 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: opening soon, as of the sponsor's last update on 25 Jun 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 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?
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 Natália MO Campelo, PhD (+35122 206 1000, nmc@ess.ipp.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the intensity and frequency of pain after the three treatment sessions; (time frame: One month after the first intervention). 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 NCT06475248, which also lists 3 linked publications.
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 25 Jun 2026.