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AzTrials

MigraineNCT07542340

Effect of Osteopathic Intervention on Migraine

A study testing Osteopathic Intervention Protocol in people with Migraine, run by Escola Superior de Tecnologia da Saúde do Porto.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Migraine is a common, disabling neurological condition characterized by severe, often unilateral pain accompanied by sensory symptoms like nausea and photophobia. Its pathophysiology involves activation of the trigeminovascular system, neuro-inflammation, and nervous system sensitisation. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Migraine
What is being tested?
Osteopathic Intervention Protocol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
45 participants
Where
No sites listed yet
Study dates
Jun 2026to Sep 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 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age between 18 and 50 years.
  • Presented five or more migraine episodes according to the criteria established by Monteiro et al. (2009), namely headache episodes with a minimum duration of 4 hours, unilateral location, pulsating character, photophobia, phonophobia, nausea, and vomiting.

Who cannot join

  • recent traumas not investigated by complementary examinations, clinical history of cranio-cervical traumas, such as fracture, dislocation, and ligament rupture (Ricard \& Sallé, 2010; Croibier, 2005);
  • tumours, meningitis, neuropraxia, disc herniation, or cervical hemivertebra (Ricard \& Sallé, 2010; Croibier, 2005);
  • contagious disease, such as tuberculosis (Croibier, 2005);
  • cardiovascular diseases, such as severe arterial hypertension, venous thrombosis, myocardial infarction, angina pectoris, recent stroke, intracranial arterial aneurysm (Croibier, 2005);
  • advanced osteoporosis (Croibier, 2005);
  • radiotherapy/chemotherapy treatment currently active or within 6 months of the last session (Croibier, 2005);
  • anticoagulant medication, vitamin K, treatment with corticosteroids, analgesics, and NSAIDs 10 to 15 days per month (Bigal et al., 2008; Croibier, 2005; International Headache Society (IHS), 2018).

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Natália MO Campelo, PhD contact

+351 222 061 000

nmc@ess.ipp.pt

About this study

Official title: Effect of Osteopathic Intervention on Migraine: A Randomised Controlled Trial

Migraine is a common, disabling neurological condition characterized by severe, often unilateral pain accompanied by sensory symptoms like nausea and photophobia. Its pathophysiology involves activation of the trigeminovascular system, neuro-inflammation, and nervous system sensitisation.

Due to the convergence of trigeminal and cervical nerves in the upper neck (C2), manual therapy may influence migraine symptoms. Osteopathic techniques, such as suboccipital inhibition and C2 manipulation, aim to reduce pain intensity and frequency by normalising mobility and reducing nociceptive stimulation. While promising, further research is needed to validate these interventions through rigorous clinical trials.

Read the detailed description

Migraine is a frequent and disabling neurological pathology, characterised by crises of moderate to severe pain, often unilateral, and accompanied by sensory phenomena such as nausea, photophobia, and phonophobia. Its pathophysiology involves the activation of brainstem nuclei, Cortical Spreading Depression, and subsequent stimulation of the trigeminovascular system. The release of neuropeptides, such as Calcitonin Gene-Related Peptide (CGRP) and Substance P, triggers sterile neuro-inflammation and both peripheral and central sensitisation, contributing to the intensity and persistence of pain.

The connection between superior cervical structures and the trigeminovascular system, particularly at the C2 level, highlights the relevance of the cervicogenic region in modulating symptomatology. The convergence of trigeminal and cervical afferents in the trigeminocervical complex explains the possibility for manual interventions to influence the clinical parameters of migraine.

Osteopathic intervention has demonstrated potential in reducing the intensity, frequency, and duration of migraines. Notable techniques include the inhibition of the suboccipital muscles, which acts upon the high tension of this musculature associated with alterations in vertebrobasilar flow and nociceptive stimuli from the atlanto-occipital region; as well as the structural technique applied to the C2 vertebra, which seeks to normalise segmental mobility and reduce the stimulation of nociceptive pathways involved in migraine pathophysiology. Existing studies suggest symptomatic improvements following the application of these techniques, although gaps in evidence persist.

In light of these elements, investigation into the efficacy of applying an osteopathic protocol to migraine presents clinical and scientific relevance, justifying its application within the context of a clinical trial.

Conditions
Migraine
Being tested
Osteopathic Intervention Protocol, Placebo technique
Keywords
Suboccipital Inhibition, Migraine, Osteopathic Manipulative Treatment, Osteopathy
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Osteopathic Intervention ProtocolOther

    Starting by locating the C2 segment with the metacarpophalangeal joint of the second finger, whilst the other hand rested on the participant's face, homolateral inclination and contralateral rotation were induced, applying a thrust directed into rotation. In this phase, two attempts were made on each side, starting with the right side.

    In the second phase, the suboccipital inhibition technique was performed in the occipital region, using contact with the thenar and hypothenar eminences, positioning the distal metacarpophalangeal joints at the level of the superior nuchal line, over the suboccipital musculature, promoting gentle pressure towards the ceiling, associated with cephalic traction, lasting for three minutes.

  • Placebo techniqueOther

    The researcher was positioned at the head of the table, making bilateral contact with the acromioclavicular joint and maintaining this position for 3 minutes, assisted by a stopwatch.

Study groups in NCT07542340
Study groupRoleWhat they receive
Control groupPlacebo comparatorIn the control group, bilateral contact of the acromioclavicular joint was performed.
Receives: Other: Placebo technique
Experimental groupExperimentalThe intervention consisted of two phases: a structural technique involving a high-velocity, low-amplitude thrust on segment C2 (Tixa \& Ebenegger, 2016), followed by a functional suboccipital inhibition technique (Chamtepie \& Pérot, 2008).
Receives: Other: Osteopathic Intervention Protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Headache Impact Test

    It consists of six questions, scored from 1 to 5, evaluating the frequency with which headache interferes with daily activities.

    Measured: Two weeks after the third intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2026
  2. Study startJun 2026 (estimated)
  3. Primary completionAug 2026 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

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
Model description
The plan consists of 3 interventions, carried out with a one-week interval between each one.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07542340
Sponsor's protocol ID
OST1-018
Status last verified
Apr 2026
First submitted
19 Feb 2026
Last updated
4 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chantepie, A., & Pérot, J. F. (2008). Osteopatia clínica e prática. Andrei.

  • Bigal ME, Serrano D, Buse D, Scher A, Stewart WF, Lipton RB. Acute migraine medications and evolution from episodic to chronic migraine: a longitudinal population-based study. Headache. 2008 Sep;48(8):1157-68. doi: 10.1111/j.1526-4610.2008.01217.x.

    PubMed 18808500

  • Croibier.A, (2005). Diagnostic ostéopathique général. Elsevier SAS

  • Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.

    PubMed 29368949

  • Tixa, S., & Ebenegger, B. (2016). Atlas de techniques articulaires ostéopathiques: Rachis cervical, thoracique, lombal et côtes (2ª ed.). Elsevier.

  • Rowlands E, Pozun A. Osteopathic Manipulative Treatment: Suboccipital Release. 2023 Mar 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK582126/

    PubMed 35881731

  • Ricard, F., Sallé, J. (2010). Tratado de osteopatía (3ª ed.). Panamericana.

  • Monteiro.J, Ribeiro.C, Luzeiro.I, Machado.M, Esperança.P, (2009). Recomendações terapêuticas para cefaleias (2.ª ed.). Sociedade Portuguesa de Neurologia & Sociedade Portuguesa de Cefaleias. 9(2).

  • Munoz-Gomez E, Ingles M, Serra-Ano P, Espi-Lopez GV. Effectiveness of a manual therapy protocol based on articulatory techniques in migraine patients. A randomized controlled trial. Musculoskelet Sci Pract. 2021 Aug;54:102386. doi: 10.1016/j.msksp.2021.102386. Epub 2021 Apr 30.

    PubMed 33989990

  • Link AS, Kuris A, Edvinsson L. Treatment of migraine attacks based on the interaction with the trigemino-cerebrovascular system. J Headache Pain. 2008 Feb;9(1):5-12. doi: 10.1007/s10194-008-0011-4. Epub 2008 Jan 23.

    PubMed 18217201

  • Machado, J., Barros, J., & Palmeira, M. (2006). Enxaqueca: fisiopatogenia, clínica e tratamento. Revista Portuguesa de Medicina Geral e Familiar, 22(4), 461-470.

  • Khan J, Asoom LIA, Sunni AA, Rafique N, Latif R, Saif SA, Almandil NB, Almohazey D, AbdulAzeez S, Borgio JF. Genetics, pathophysiology, diagnosis, treatment, management, and prevention of migraine. Biomed Pharmacother. 2021 Jul;139:111557. doi: 10.1016/j.biopha.2021.111557. Epub 2021 May 17.

    PubMed 34243621

Questions about this trial

What is this clinical trial studying?

A study testing Osteopathic Intervention Protocol in people with Migraine, run by Escola Superior de Tecnologia da Saúde do Porto.

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 7 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 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

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 (+351 222 061 000, nmc@ess.ipp.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Headache Impact Test (time frame: Two weeks after the third 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 NCT07542340, which also lists 12 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 4 May 2026.

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