Effect of Osteopathic Intervention on Migraine

NCT07542340 | Not Yet Recruiting

• 1 other identifier: OST1-018
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Migraine

Keywords

Suboccipital Inhibition; Migraine; Osteopathic Manipulative Treatment; Osteopathy

Outcome Measures

Primary Outcomes (1)

• Headache Impact Test

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

  Two weeks after the third intervention

Study Arms (2)

Control group

PLACEBO COMPARATOR

In the control group, bilateral contact of the acromioclavicular joint was performed.

Other: Placebo technique

Experimental group

EXPERIMENTAL

The 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).

Other: Osteopathic Intervention Protocol

Interventions

Osteopathic Intervention Protocol OTHER

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.

Experimental group

Placebo technique OTHER

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.

Control group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Escola Superior de Tecnologia da Saúde do Porto: lead

Related Publications (12)

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

  BACKGROUND

• Bigal, M. E., Serrano, D., Buse, D., Scher, A., Stewart, W. F., & Lipton, R. B. (2008). Acute migraine medications and evolution from episodic to chronic migraine: A longitudinal population-based study. Headache, 48(8), 1157-1168. https://doi.org/10.1111/j.1526-4610.2008.01217.x

  BACKGROUND

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

  BACKGROUND

• International Headache Society (IHS). (2018). Headache Classification Committee of the International Headache Society . The International Classification of Headache Disorders, 3rd Edition. Cephalalgia, v.38, n.1, p.1-211.https://doi.org/0.1177/0333102417738202 .

  BACKGROUND

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

  BACKGROUND

• Rowlands, E., & Pozun, A. (2023). Osteopathic Manipulative Treatment: Suboccipital Release. Em StatPearls. StatPearls Publishing. http://www.ncbi.nlm.nih.gov/books/NBK582126/

  BACKGROUND

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

  BACKGROUND

• 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).

  BACKGROUND

• Muñoz-Gómez, E., Inglés, M., Serra-Añó, P., & Espí-López, G. V. (2021). Effectiveness of a manual therapy protocol based on articulatory techniques in migraine patients. A randomized controlled trial. Musculoskeletal Science and Practice, 54, 102386. https://doi.org/10.1016/j.msksp.2021.102386

  BACKGROUND

• Link, A.S., Kuris, A. & Edvinsson, L. (2008). Treatment of migraine attacks based on the interaction with the trigemino-cerebrovascular system. J Headache Pain 9, 5-12. https://doi.org/10.1007/s10194-008-0011-4

  BACKGROUND

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

  BACKGROUND

• Khan, J., Al Asoom, L. I., Al Sunni, A., Rafique, N., Latif, R., Al Saif, S., Almandil, N. B., Almohazey, D., AbdulAzeez, S., Borgio, J. F. (2021). Genetics, pathophysiology, diagnosis, treatment, management, and prevention of migraine. Biomed Pharmacother. https://doi.org/10.1016/j.biopha.2021.111557

  BACKGROUND

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Natália MO Campelo

  ESS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natália MO Campelo, PhD

CONTACT

+351 222 061 000; nmc@ess.ipp.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor teacher

Model Details: The plan consists of 3 interventions, carried out with a one-week interval between each one.

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: April 21, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share