Effect of Osteopathic Intervention on Migraine

Official title

Effect of Osteopathic Intervention on Migraine: A Randomised Controlled Trial

Overview

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.

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.

Interventions

• 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, positio
• 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.

Primary outcome measures

• Headache Impact Test [Time frame: Two weeks after the third intervention]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 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. PMID 29368949
• 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).

Identifiers

NCT: NCT07542340 · OST1-018

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗