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慢性下腰痛患者从早期干预减少缺勤中获益吗?一项随机、对照、单中心试点研究。

Do Patients With Chronic Low Back Pain Benefit From Early Intervention Regarding Absence From Work?: A Randomized, Controlled, Single-Center Pilot Study.

作者信息

Norbye Anja Davis, Omdal Aina Vedvik, Nygaard Marit Eikrem, Romild Ulla, Eldøen Guttorm, Midgard Rune

机构信息

Department of Neurology, Molde Hospital, Møre and Romsdal Health Trust, Molde, Norway.

Swedish National Institute of Public Health, Ostersund, Sweden.

出版信息

Spine (Phila Pa 1976). 2016 Nov 1;41(21):E1257-E1264. doi: 10.1097/BRS.0000000000001878.

Abstract

STUDY DESIGN

A randomized, controlled, single-center pilot study.

OBJECTIVE

The aim of this study was to investigate the feasibility of running a trial to explore if early intervention in individuals with chronic low back pain (CLBP) would lead to an early return to work (RTW) and reduce sick leave during 12 months of follow-up compared with patients on a 3-month waiting list.

SUMMARY OF BACKGROUND DATA

Back pain is the reason for numerous absent days from work. In Norway, the government initiated a priority program, Earlier Return to Work (ERTW), to reduce work absences through early intervention. However, no proper evaluation has been performed on populations with CLBP. There is no consensus on how RTW should be measured. Only a few studies have examined how waiting time affects RTW.

METHODS

Fifty-eight patients were included in the study. The group with early intervention was examined within 2 weeks, and the group on the waiting list was examined after 12 weeks. The intervention was identical in both groups and consisted of an outpatient, intensive back school. The data were obtained by questionnaire after 3, 6, and 12 months. The primary outcome was absence from work.

RESULTS

The sample size in a full-scale study must comprise at least 382 patients on the basis of the assumptions in the pilot. In the pilot study, early intervention directly compared with an ordinary waiting list did not significantly affect the number of sick leave days after 12 months of follow-up.

CONCLUSION

A prerequisite for launching a full-scale clinical trial is a redesign of the intervention, an improvement of procedures concerning inclusion and randomization, and finally a more precise definition of RTW.

LEVEL OF EVIDENCE

摘要

研究设计

一项随机、对照、单中心的试点研究。

目的

本研究旨在探讨对慢性下腰痛(CLBP)患者进行早期干预,与等待3个月的患者相比,是否能在12个月的随访期内促使其早日重返工作岗位(RTW)并减少病假天数。

背景数据总结

背痛是导致大量缺勤的原因。在挪威,政府启动了一项优先计划,即早日重返工作岗位(ERTW),以通过早期干预减少工作缺勤。然而,尚未对CLBP人群进行适当评估。对于如何衡量RTW尚无共识。仅有少数研究探讨了等待时间对RTW的影响。

方法

58名患者纳入本研究。早期干预组在2周内接受检查,等待名单组在12周后接受检查。两组干预措施相同,均包括门诊强化背部康复课程。在3、6和12个月后通过问卷调查获取数据。主要结局指标为缺勤情况。

结果

根据试点研究的假设,大规模研究的样本量必须至少包括382名患者。在试点研究中,早期干预与普通等待名单直接比较,在12个月的随访期后,对病假天数无显著影响。

结论

开展大规模临床试验的前提是重新设计干预措施,改进纳入和随机化程序,最后更精确地定义RTW。

证据级别

3级。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cf9e/5113231/7df0bd9aa6e5/brs-41-e1257-g001.jpg

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