手法治疗、颈部肌肉锻炼和治疗性疼痛神经科学教育联合治疗偏头痛患者的效果：一项随机临床试验研究方案。

Effects of combining manual therapy, neck muscle exercises, and therapeutic pain neuroscience education in patients with migraine: a study protocol for a randomized clinical trial.

机构信息

Department of Health Sciences - Ribeirão Preto Medical School, University of São Paulo, 3900, Bandeirantes Avenue - Monte Alegre, Ribeirão Preto, SP, 14049-900, Brazil.

Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos, Alcorcón, Spain.

出版信息

BMC Neurol. 2021 Jun 29;21(1):249. doi: 10.1186/s12883-021-02290-w.

DOI:10.1186/s12883-021-02290-w

PMID:34187384

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8240357/

Abstract

BACKGROUND

Non-pharmacological approaches for the management of migraine exhibit low to moderate effectiveness due to a lack of high-quality randomized clinical trials. In fact, previous studies applied isolated techniques, which were not representative of common clinical practice. A multimodal approach for migraine may benefit these patients more than isolated approaches. This randomized clinical trial aims to determine the effectiveness of a multimodal protocol combining manual therapy, exercise, and therapeutic pain neuroscience education versus the application of manual therapy or pain neuroscience education alone in patients with migraine.

METHODS

This clinical trial will include 75 individuals of both sexes, aged between 18 and 55 years, with migraine. Participants will be randomized into three groups: the therapeutic pain neuroscience education (TPNE; n = 25) group, the manual therapy (MT; n = 25) group, and the multimodal (MM; n = 25) group. The TPNE group will receive one orientation session on migraine and pain self-management, and recommendations for daily active stretching and walking, with subsequent therapist monitoring. The MT group will receive manual therapies targeting musculoskeletal disorders of the cervical spine. The MM group will receive manual therapies targeting musculoskeletal disorders of the cervical spine, active neck exercises, and therapeutic pain neuroscience education. The treatment period will last 12 weeks. The primary outcome will be the headache impact, measured using the Headache Impact Test (HIT-6). Secondary outcomes will include migraine frequency and intensity, cervical mobility and strength parameters, neck pain-related disability, kinesiophobia, cutaneous allodynia, pain-related catastrophizing, quality of life, and self-perception of change. All outcomes will be evaluated at the fourth, eighth, and twelfth weeks of the treatment period. Primary and secondary clinical outcomes, such as headache impact, frequency, and intensity, will also be evaluated at the 1-, 2-, and 4-month follow-ups.

DISCUSSION

The results of this randomized clinical trial may provide high-quality clinical evidence of the effects of non-pharmacological treatment options for the management of migraine.

TRIAL REGISTRATION

This study was registered under the access code RBR-7s22c75 in the Registro Brasileiro de Ensaios Clínicos (ReBEC) in December 2020.

摘要

背景

由于缺乏高质量的随机临床试验，非药物治疗偏头痛的方法效果较低或中等。事实上，以前的研究应用了孤立的技术，这些技术不能代表常见的临床实践。针对偏头痛的多模式方法可能比单一方法更有益于这些患者。本随机临床试验旨在确定结合手法治疗、运动和治疗性疼痛神经科学教育的多模式方案与单独应用手法治疗或疼痛神经科学教育在偏头痛患者中的疗效。

方法

本临床试验将纳入 75 名 18-55 岁的男女偏头痛患者。参与者将随机分为三组：治疗性疼痛神经科学教育（TPNE；n=25）组、手法治疗（MT；n=25）组和多模式（MM；n=25）组。TPNE 组将接受一次关于偏头痛和疼痛自我管理的方向课程，以及日常主动伸展和步行的建议，并进行后续治疗师监测。MT 组将接受针对颈椎肌肉骨骼疾病的手法治疗。MM 组将接受针对颈椎肌肉骨骼疾病、主动颈部运动和治疗性疼痛神经科学教育的手法治疗。治疗期将持续 12 周。主要结局将是头痛影响，使用头痛影响测试（HIT-6）进行测量。次要结局将包括偏头痛频率和强度、颈椎活动度和力量参数、颈部疼痛相关残疾、运动恐惧症、皮肤感觉过敏、疼痛相关灾难化、生活质量和自我感知的变化。所有结果将在治疗期的第 4、8 和 12 周进行评估。主要和次要临床结局，如头痛影响、频率和强度，也将在治疗后 1、2 和 4 个月进行评估。