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腰椎内固定融合术与认知干预及运动疗法对慢性下腰痛伴椎间盘退变患者的随机临床试验

Randomized clinical trial of lumbar instrumented fusion and cognitive intervention and exercises in patients with chronic low back pain and disc degeneration.

作者信息

Brox Jens Ivar, Sørensen Roger, Friis Astrid, Nygaard Øystein, Indahl Aage, Keller Anne, Ingebrigtsen Tor, Eriksen Hege R, Holm Inger, Koller Anne Kathrine, Riise Rolf, Reikerås Olav

机构信息

Department of Orthopedic Surgery, National Hospital, Oslo, Norway.

出版信息

Spine (Phila Pa 1976). 2003 Sep 1;28(17):1913-21. doi: 10.1097/01.BRS.0000083234.62751.7A.

DOI:10.1097/01.BRS.0000083234.62751.7A
PMID:12973134
Abstract

STUDY DESIGN

Single blind randomized study.

OBJECTIVES

To compare the effectiveness of lumbar instrumented fusion with cognitive intervention and exercises in patients with chronic low back pain and disc degeneration.

SUMMARY OF BACKGROUND DATA

To the authors' best knowledge, only one randomized study has evaluated the effectiveness of lumbar fusion. The Swedish Lumbar Spine Study reported that lumbar fusion was better than continuing physiotherapy and care by the family physician.

PATIENTS AND METHODS

Sixty-four patients aged 25-60 years with low back pain lasting longer than 1 year and evidence of disc degeneration at L4-L5 and/or L5-S1 at radiographic examination were randomized to either lumbar fusion with posterior transpedicular screws and postoperative physiotherapy, or cognitive intervention and exercises. The cognitive intervention consisted of a lecture to give the patient an understanding that ordinary physical activity would not harm the disc and a recommendation to use the back and bend it. This was reinforced by three daily physical exercise sessions for 3 weeks. The main outcome measure was the Oswestry Disability Index.

RESULTS

At the 1-year follow-up visit, 97% of the patients, including 6 patients who had either not attended treatment or changed groups, were examined. The Oswestry Disability Index was significantly reduced from 41 to 26 after surgery, compared with 42 to 30 after cognitive intervention and exercises. The mean difference between groups was 2.3 (-6.7 to 11.4) (P = 0.33). Improvements inback pain, use of analgesics, emotional distress, life satisfaction, and return to work were not different. Fear-avoidance beliefs and fingertip-floor distance were reduced more after nonoperative treatment, and lower limb pain was reduced more after surgery. The success rate according to an independent observer was 70% after surgery and 76% after cognitive intervention and exercises. The early complication rate in the surgical group was 18%.

CONCLUSION

The main outcome measure showed equal improvement in patients with chronic low back pain and disc degeneration randomized to cognitive intervention and exercises, or lumbar fusion.

摘要

研究设计

单盲随机研究。

目的

比较腰椎器械融合术联合认知干预与运动疗法对慢性下腰痛和椎间盘退变患者的疗效。

背景资料总结

据作者所知,仅有一项随机研究评估了腰椎融合术的疗效。瑞典腰椎研究报告称,腰椎融合术优于继续接受物理治疗和家庭医生的护理。

患者与方法

64例年龄在25至60岁之间、下腰痛持续时间超过1年且影像学检查显示L4-L5和/或L5-S1椎间盘退变的患者,被随机分为接受后路椎弓根螺钉腰椎融合术及术后物理治疗组,或认知干预与运动疗法组。认知干预包括一次讲座,让患者了解日常体力活动不会损害椎间盘,并建议其使用背部并弯曲背部。这通过为期3周的每日三次体育锻炼得以强化。主要结局指标为奥斯威斯残疾指数。

结果

在1年随访时,检查了97%的患者,包括6例未接受治疗或更换组别的患者。与认知干预和运动疗法后从42降至30相比,手术后奥斯威斯残疾指数从41显著降至26。两组间的平均差异为2.3(-6.7至11.4)(P = 0.33)。背痛、镇痛药使用、情绪困扰、生活满意度及重返工作方面的改善无差异。非手术治疗后恐惧回避信念和指尖至地面距离降低更多,手术后下肢疼痛减轻更多。独立观察者评估的手术成功率为70%,认知干预和运动疗法后为76%。手术组的早期并发症发生率为18%。

结论

主要结局指标显示,随机接受认知干预和运动疗法或腰椎融合术的慢性下腰痛和椎间盘退变患者的改善程度相当。

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