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不同物理疗法干预在颈源性头痛管理中的有效性:一项初步随机对照试验。

Effectiveness of different physiotherapy interventions in the management of cervicogenic headache: a pilot randomized controlled trial.

机构信息

Department of Physiotherapy, Guru Jambheshwar University of Science & Technology, Hisar, Haryana, India.

出版信息

J Man Manip Ther. 2022 Apr;30(2):96-104. doi: 10.1080/10669817.2021.1962687. Epub 2021 Aug 10.

Abstract

BACKGROUND

Cervicogenic headache is a secondary headache which leads to decreased functional activity, quality of life and functional disability.

OBJECTIVE

To determine the feasibility and acceptability of different physiotherapy interventions in the management of cervicogenic headache and to determine sample size for a full trial.

TRIAL DESIGN

A pilot randomized controlled trial.

SETTINGS

Various physiotherapy outpatient department.

METHODS

Participants suffering from cervicogenic headache with age 20- 60 years were randomly allocated into four groups. Sessions were given over 4 weeks 4 times a week (16 sessions). The primary outcomes were feasibility of participant recruitment, assessment procedure, retention, adherence, and acceptability. The secondary outcomes were headache impact test-6 for a headache disability, headache diary for headache intensity, frequency, duration, and neck disability index for neck pain, disability measured at baseline, 4th week, and follow up after 1 month.

RESULT

178 subjects were screened based on selection criteria. Out of them, 93 (52%) were eligible and 80 (86%) participated in the study. 96.25% of participants completed the final 8-week assessment. Overall 93.75% of participants completed the entire assessment item across all time points. 95% completed all treatment sessions. 97.5-100% of participants were satisfied with the treatment protocol. No adverse effects were reported by participants. Based on the data obtained from the pilot trial, sample size was determined as 35 participants in each group.

CONCLUSION

The results indicate that the trial methodology and intervention are feasible for implementing a full-powered randomized controlled trial to determine the effectiveness of physiotherapy intervention in the management of cervicogenic headache.

摘要

背景

颈源性头痛是一种继发性头痛,会导致功能活动、生活质量和功能障碍下降。

目的

确定不同物理治疗干预措施在颈源性头痛管理中的可行性和可接受性,并确定全试验样本量。

试验设计

一项先导随机对照试验。

设置

各种物理治疗门诊。

方法

将年龄在 20-60 岁之间患有颈源性头痛的参与者随机分配到四组。每周 4 次,每次 4 次,共 4 周进行治疗(共 16 次)。主要结局是参与者招募、评估程序、保留、依从性和可接受性的可行性。次要结局是头痛影响测试-6(用于评估头痛残疾)、头痛日记(用于评估头痛强度、频率、持续时间)、颈部残疾指数(用于评估颈部疼痛、残疾),在基线、第 4 周和随访 1 个月时进行测量。

结果

根据选择标准对 178 名受试者进行了筛选。其中,93 名(52%)符合条件,80 名(86%)参加了研究。96.25%的参与者完成了最终的 8 周评估。总体而言,93.75%的参与者在所有时间点都完成了所有评估项目。95%的参与者完成了所有治疗课程。97.5-100%的参与者对治疗方案表示满意。参与者未报告任何不良反应。根据先导试验获得的数据,确定每组 35 名参与者为样本量。

结论

结果表明,该试验方法和干预措施在实施全效随机对照试验以确定物理治疗干预在颈源性头痛管理中的有效性方面是可行的。

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