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临床试验/NCT07542340
NCT07542340尚未招募不适用

Effect of Osteopathic Intervention on Migraine: A Randomised Controlled Trial

Escola Superior de Tecnologia da Saúde do Porto0 个研究点目标入组 45 人开始时间: 2026年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
45
主要终点
Headache Impact Test

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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).

研究组 & 干预措施

Control group

Placebo Comparator

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

干预措施: Placebo technique (Other)

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).

干预措施: Osteopathic Intervention Protocol (Other)

结局指标

主要结局

Headache Impact Test

时间窗: Two weeks after the third intervention

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Natália Maria Oliveira Campelo

Doctor teacher

Escola Superior de Tecnologia da Saúde do Porto

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