Effect of Osteopathic Intervention on Migraine

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Migraine
• Intervention / Treatment: Other: Placebo technique; Other: Osteopathic Intervention Protocol

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.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Natália MO Campelo, PhD; Phone Number: +351 222 061 000; Email: nmc@ess.ipp.pt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; In the control group, bilateral contact of the acromioclavicular joint was performed.	Other: Placebo technique; 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.
Experimental: Experimental group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Escola Superior de Tecnologia da Saúde do Porto
• Investigators: Principal Investigator: Natália MO Campelo, ESS

Publications and helpful links

General Publications

• Chantepie, A., & Pérot, J. F. (2008). Osteopatia clínica e prática. Andrei.
• 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
• Croibier.A, (2005). Diagnostic ostéopathique général. Elsevier SAS
• 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 .
• Tixa, S., & Ebenegger, B. (2016). Atlas de techniques articulaires ostéopathiques: Rachis cervical, thoracique, lombal et côtes (2ª ed.). Elsevier.
• Rowlands, E., & Pozun, A. (2023). Osteopathic Manipulative Treatment: Suboccipital Release. Em StatPearls. StatPearls Publishing. http://www.ncbi.nlm.nih.gov/books/NBK582126/
• 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).
• 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
• 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
• 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., 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

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: February 19, 2026
• First Submitted That Met QC Criteria: April 14, 2026
• First Posted (Actual): April 21, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Migraine; Osteopathic Manipulative Treatment; Osteopathy; Suboccipital Inhibition
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: OST1-018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No