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一项比较两种治疗方案治疗头痛和颈痛患者的随机临床试验的初步结果、方法学考虑因素和招募困难。

Preliminary results, methodological considerations and recruitment difficulties of a randomised clinical trial comparing two treatment regimens for patients with headache and neck pain.

机构信息

Faculty of Physical Education and Physical Therapy, Vrije Universiteit Brussel, Brussels, Belgium.

出版信息

BMC Musculoskelet Disord. 2009 Sep 23;10:115. doi: 10.1186/1471-2474-10-115.

DOI:10.1186/1471-2474-10-115
PMID:19775434
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2758835/
Abstract

BACKGROUND

Headache is a highly prevalent disorder. Irrespective of the headache diagnosis it is often accompanied with neck pain and -stiffness. Due to this common combination of headache and neck pain, physical treatments of the cervical spine are often considered. The additional value of these treatments to standard medical care or usual care (UC) is insufficiently documented.We therefore wanted to compare the treatment effects of UC alone and in combination with manual therapy (MT) in patients with a combination of headache and neck pain. UC consisted of a stepped treatment approach according to the Dutch General Practitioners Guideline for headache, the additional MT consisted of articular mobilisations and low load exercises.Due to insufficient enrolment the study was terminated prematurely. We aim to report not only our preliminary clinical findings but also to discuss the encountered difficulties and to formulate recommendations for future research.

METHODS

A randomised clinical trial was conducted. Thirty-seven patients were included and randomly allocated to one of both treatment groups. The treatment period was 6 weeks, with follow-up measurements at weeks 7, 12 and 26. Primary outcome measures were global perceived effect (GPE) and the impact of the headache using the Headache Impact Test (HIT-6). Reduction in headache frequency, pain intensity, medication intake, absenteeism and the use of additional professional help were secondary outcome measures

RESULTS

Significant improvements on primary and secondary outcome measures were recorded in both treatment groups. No significant differences between both treatment groups were found. The number of recruited patients remained low despite various strategies.

CONCLUSION

It appears that both treatment strategies can have equivalent positive influences on headache complaints. Additional studies with larger study populations are needed to draw firm conclusions. Recommendations to increase patient inflow in primary care trials, such as the use of an extended network of participating physicians and of clinical alert software applications, are discussed.

TRIAL REGISTRATION NUMBER

NCT00298142.

摘要

背景

头痛是一种高发疾病。无论头痛诊断如何,它通常伴有颈部疼痛和僵硬。由于头痛和颈部疼痛的常见组合,通常会考虑对颈椎进行物理治疗。这些治疗方法对标准医疗护理或常规护理(UC)的额外价值尚未得到充分证明。因此,我们希望比较 UC 单独治疗和联合手动治疗(MT)在头痛和颈部疼痛同时存在的患者中的治疗效果。UC 包括根据荷兰全科医生头痛指南进行的阶梯治疗方法,额外的 MT 包括关节松动术和低负荷运动。由于入组人数不足,该研究提前终止。我们不仅旨在报告初步的临床发现,还讨论所遇到的困难,并为未来的研究提出建议。

方法

进行了一项随机临床试验。纳入了 37 名患者,并随机分配到两个治疗组之一。治疗期为 6 周,在第 7、12 和 26 周进行随访测量。主要结局指标是整体感知效果(GPE)和头痛影响使用头痛影响测试(HIT-6)。次要结局指标包括头痛发作频率、疼痛强度、药物摄入、缺勤和额外专业帮助的使用减少。

结果

两组治疗组均记录到主要和次要结局指标的显著改善。两组治疗组之间未发现显著差异。尽管采取了各种策略,但招募的患者人数仍然较少。

结论

似乎两种治疗策略都可以对头痛症状产生同等的积极影响。需要更大的研究人群进行进一步研究以得出明确的结论。讨论了增加初级保健试验中患者流量的建议,例如使用扩展的参与医生网络和临床警报软件应用程序。

试验注册号

NCT00298142。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/eefd/2758835/23a632c3ad91/1471-2474-10-115-2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/eefd/2758835/daeff04c3049/1471-2474-10-115-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/eefd/2758835/23a632c3ad91/1471-2474-10-115-2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/eefd/2758835/daeff04c3049/1471-2474-10-115-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/eefd/2758835/23a632c3ad91/1471-2474-10-115-2.jpg

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