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挥鞭样损伤相关疾病患者保守治疗的随机临床试验:设计与动态治疗方案的考量

Randomized clinical trial of conservative treatment for patients with whiplash-associated disorders: considerations for the design and dynamic treatment protocol.

作者信息

Scholten-Peeters Gwendolijne G M, Verhagen Arianne P, Neeleman-van der Steen Catharina W M, Hurkmans John C A M, Wams Ria W A, Oostendorp Rob A B

机构信息

Dutch National Institute of Allied Health Professions, PO Box 1161, 3800 BD Amersfoort, The Netherlands.

出版信息

J Manipulative Physiol Ther. 2003 Sep;26(7):412-20. doi: 10.1016/S0161-4754(03)00092-7.

Abstract

BACKGROUND

Whiplash concerns a considerable problem to health care. Available evidence from systematic reviews indicates beneficial effects of active interventions for patients with whiplash injury. In order to evaluate whether a general practitioner or a physiotherapist should provide these active interventions, we have designed a randomized clinical trial.

OBJECTIVE

The purpose of this article is to present the design of the trial and to provide transparency into the dynamic treatment protocol used.

PATIENTS

Patients with whiplash-associated disorders grade I and II who still have symptoms and disabilities 4 weeks after the accident.

INTERVENTIONS

A dynamic treatment protocol consisting of 4 different subprotocols. The primary aim is to increase their activities and to improve their quality of life. Content and intensity of treatment are described. Outcome measures The primary outcome measures are pain and disability. The short-term effects are measured at 12 weeks and long-term effects at 1 year after the trauma.

CONCLUSION

To date, generally the effect of one intervention compared to another intervention has been examined. In our opinion, this cannot be considered as usual care for physiotherapy or general practice. Therefore, a dynamic treatment protocol has been developed to structure the black box of usual physiotherapy and general practice treatment. The results of this trial will be available in 0.5 year.

摘要

背景

挥鞭样损伤给医疗保健带来了相当大的问题。系统评价的现有证据表明,积极干预对挥鞭样损伤患者有有益效果。为了评估应由全科医生还是物理治疗师提供这些积极干预措施,我们设计了一项随机临床试验。

目的

本文的目的是介绍该试验的设计,并使所采用的动态治疗方案具有透明度。

患者

事故发生4周后仍有症状和残疾的I级和II级挥鞭样相关疾病患者。

干预措施

一种由4种不同子方案组成的动态治疗方案。主要目的是增加他们的活动并改善他们的生活质量。描述了治疗的内容和强度。结局指标主要结局指标是疼痛和残疾。在创伤后12周测量短期效果,在1年后测量长期效果。

结论

迄今为止,通常是比较一种干预措施与另一种干预措施的效果。我们认为,这不能被视为物理治疗或全科医疗的常规护理。因此,已制定了一种动态治疗方案,以构建常规物理治疗和全科医疗治疗的黑箱。该试验的结果将在半年后公布。

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