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电刺激对老年患者腰椎融合的影响:一项随机、对照、多中心试验:第 1 部分:功能结局。

The effect of electrical stimulation on lumbar spinal fusion in older patients: a randomized, controlled, multi-center trial: part 1: functional outcome.

机构信息

Orthopaedic Department E, Spine Section, Aarhus University Hospital, Aarhus, Denmark.

出版信息

Spine (Phila Pa 1976). 2009 Oct 1;34(21):2241-7. doi: 10.1097/BRS.0b013e3181b02988.

DOI:10.1097/BRS.0b013e3181b02988
PMID:19934802
Abstract

STUDY DESIGN

Randomized, controlled, multi-center trial.

OBJECTIVE

To investigate the effect of direct current (DC) electrical stimulation on functional and clinical outcome after lumbar spinal fusion in patients older than 60 years.

SUMMARY OF BACKGROUND DATA

Older patients have increased complication rates after spinal fusion surgery. Treatments which have the possibility of enhancing functional outcome and fusion rates without lengthening the procedure could prove beneficial. DC-stimulation of spinal fusion has proven effective in increasing fusion rates in younger and "high risk" patients, but functional outcome measures have not been reported.

METHODS

A randomized, clinical trial comprising 5 orthopedic centers. The study included a total of 107 patients randomized to uninstrumented posterolateral lumbar spinal fusion with or without DC-stimulation. Functional outcome was assessed using Dallas Pain Questionnaire, SF-36, Low Back Pain Rating Scale pain index, and walking distance.

RESULTS

Follow-up after 1 year was 95/107 (89%). DC-stimulated patients had significant better outcome in 3 of 4 categories in the Dallas Pain Questionnaire, better SF-36 scores (not significantly), but no difference in pain scores were observed. Median walking distance at latest follow-up was better in the stimulated group (not significant). Walking distance was significantly associated with functional outcome. There was no difference in any of the functional outcome scores between patients who experienced a perioperative complication and those without complications.

CONCLUSION

The achievement of a good functional outcome was heavily dependent on the obtained walking distance. DC-stimulated patients tended to have better functional outcome as compared to controls. No negative effects of perioperative complications could be observed on the short-term functional outcome.

摘要

研究设计

随机对照多中心试验。

目的

研究直流电(DC)刺激对 60 岁以上腰椎融合术后功能和临床结果的影响。

背景资料概要

老年患者脊柱融合手术后并发症发生率增加。如果有一种治疗方法有可能在不延长手术时间的情况下提高功能结果和融合率,那么这种方法可能会很有帮助。直流电刺激在增加年轻和“高风险”患者的融合率方面已被证明是有效的,但尚未报告功能结果测量。

方法

一项由 5 个骨科中心组成的随机临床试验。该研究共纳入 107 例患者,随机分为未器械化的后路腰椎融合术加或不加直流电刺激。使用达拉斯疼痛问卷、SF-36、腰痛评分量表疼痛指数和步行距离来评估功能结果。

结果

107 例患者中有 95 例(89%)进行了 1 年随访。在达拉斯疼痛问卷的 4 个类别中的 3 个类别中,直流电刺激组的患者具有显著更好的结果,SF-36 评分更好(但无统计学意义),但疼痛评分无差异。在最新随访时,刺激组的中位步行距离更好(无统计学意义)。步行距离与功能结果显著相关。在经历围手术期并发症和无并发症的患者之间,任何功能结果评分均无差异。

结论

获得良好的功能结果在很大程度上取决于获得的步行距离。与对照组相比,直流电刺激组的患者功能结果往往更好。围手术期并发症对短期功能结果没有负面影响。

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