Department of Musculoskeletal Physiotherapy, Smt. Kashibai Navale College of Physiotherapy, Off Westerly by Pass, Narhe, Pune, Maharashatra, 411041, India.
Department of Musculoskeletal Physiotherapy, Sancheti Institute College of Physiotherapy, Thube Park, Shivaji Nagar, Pune, Maharashatra, 411001, India.
BMC Musculoskelet Disord. 2021 Mar 3;22(1):243. doi: 10.1186/s12891-021-04105-y.
Non - pharmacological management of migraine, tension-type headache (TTH), and cervicogenic headache (CGH) may include spinal manual therapy and exercise. Mulligan Manual Therapy (MMT) utilizes a protocol of headache elimination procedures to manage headache parameters and associated disability, but has only been evaluated in CGH. There is little evidence for its effectiveness in migraine and TTH. This study aims to determine the effectiveness of MMT and exercise over exercise and placebo in the management of migraine, TTH, and CGH.
This pragmatic trial is designed as a prospective, three-armed randomised controlled trial in a clinical setting provided at a general hospital physiotherapy department. Two hundred ninety-seven participants with a diagnosis of migraine, TTH or CGH based on published headache classification guidelines will be included. An assessor blind to group allocation will measure outcomes pre-and post-intervention as well as 3 and 6 months after commencement of treatment. Participants will be allocated to one of the three groups: MMT and exercise; placebo and exercise; and exercise alone. The primary outcome measure is headache frequency. Secondary outcome measures are headache duration and intensity, medication intake, pressure pain threshold (PPT), range of motion recorded with the flexion rotation test, and headache disability recorded with Headache Activities of Daily Living Index (HADLI). The intention-to-treat principle will be followed for statistical analysis. Between groups differences for all outcome measures at baseline and at reassessment points and 95% confidence intervals will be calculated using a mixed model ANOVA. Post hoc tests will be conducted to identify any significant difference between groups and over time.
This pragmatic study will provide evidence for the effectiveness of MMT when compared with a placebo intervention and exercise on headache frequency, intensity, and disability. Limitations are that baseline evaluation of headache parameters may be affected by recall bias. External validity will be limited to the population with a minimum 1-year history of headache. The HADLI is not yet extensively evaluated for its psychometric properties and association between PPT and headache parameters is lacking. Performance bias is inevitable as a single therapist will be delivering all interventions.
The trial was registered prospectively under the Clinical Trial Registry India (Registration number: CTRI/2019/06/019506 , dated on 03/06/2019). .
偏头痛、紧张型头痛（TTH）和颈源性头痛（CGH）的非药物治疗可能包括脊柱手法治疗和运动。 Mulligan 手法治疗（MMT）采用头痛消除程序的方案来管理头痛参数和相关残疾，但仅在 CGH 中进行了评估。其在偏头痛和 TTH 中的有效性证据很少。本研究旨在确定 MMT 和运动在偏头痛、TTH 和 CGH 的治疗中比运动和安慰剂更有效。
这是一项在综合医院物理治疗科提供的临床环境中进行的前瞻性、三臂随机对照试验。将纳入 297 名根据已发表的头痛分类指南诊断为偏头痛、TTH 或 CGH 的参与者。一名对分组分配不知情的评估者将在干预前后以及治疗开始后 3 个月和 6 个月测量结局。参与者将被分配到以下三组之一：MMT 和运动；安慰剂和运动；以及单独运动。主要结局测量指标是头痛频率。次要结局测量指标是头痛持续时间和强度、药物摄入、压力疼痛阈值（PPT）、屈伸旋转试验记录的运动范围以及头痛日常生活活动指数（HADLI）记录的头痛残疾。将遵循意向治疗原则进行统计分析。使用混合模型方差分析计算所有结局测量在基线和重新评估点以及 95%置信区间的组间差异，并进行事后检验以确定组间和随时间的任何显著差异。
这项实用研究将提供证据，证明与安慰剂干预和运动相比，MMT 在头痛频率、强度和残疾方面的有效性。局限性在于，头痛参数的基线评估可能受到回忆偏倚的影响。外部有效性将仅限于至少有 1 年头痛病史的人群。HADLI 尚未广泛评估其心理测量特性，并且缺乏 PPT 与头痛参数之间的关联。由于一名治疗师将提供所有干预措施，因此难免会出现绩效偏差。
该试验在印度临床试验注册处进行了前瞻性注册（注册号：CTRI/2019/06/019506，日期为 2019 年 6 月 3 日）。
