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经皮椎间孔臭氧治疗联合或不联合周围神经周围类固醇注射治疗腰椎间盘突出症的疗效:一项双盲对照研究。

Efficacy of Intradiscal Ozone Therapy with or without Periforaminal Steroid Injection on Lumbar Disc Herniation: A Double-Blinded Controlled Study.

机构信息

Department of Physical Medicine and Rehabilitation, Division of Pain Medicine, Sisli Hamidiye Etfal Training and Research Hospital, Turkey.

1Department of Physical Medicine and Rehabilitation, Division of Pain Medicine, Health Sciences University, Sisli Hamidiye Etfal Training and Research Hospital, Turkey; 2Department of Neurosurgery, Health Sciences University, Sisli Hamidiye Etfal Training and Research Hospital, Turkey.

出版信息

Pain Physician. 2020 Sep;23(5):477-484.

Abstract

BACKGROUND

Intradiscal ozone therapy, a minimally invasive technique, is used in patients that do not respond to standard conservative therapies for low back pain due to degenerative disc-induced lumbar disc herniation (LDH). Many studies on clinical efficacy lack a standardized injection method and are limited by inadequate study design.

OBJECTIVE

This study aimed to determine the efficacy of periforaminal steroid injection together with intradiscal ozone therapy.

STUDY DESIGN

A prospective, double-blinded, randomized controlled trial.

SETTING

A tertiary care center.

METHODS

This study was conducted in 65 patients with low back and leg pain caused by LDH. Group 1 received intradiscal ozone therapy (n = 35) and Group 2 received intradiscal ozone therapy with periforaminal steroid injection (n = 30). Patients were evaluated for pain using the visual analogue scale (VAS), for disability using Oswestry Disability Index (ODI), and for quality of life using the short form 36 health survey administered pre-injection and at one and 6 months post-injection. All procedures were performed under sterile conditions using C-arm fluoroscopy.

RESULTS

Significant improvements were observed in pain, disability, and quality of life in both groups post-treatment compared to pre-injection. Mean pre-injection VAS was not significantly different between the groups (VAS: 7.8 ± 1.1 for Group 1, 7.8 ± 1.2 for Group 2). VAS values at 6 months for Group 1 and Group 2 were as follows: 3.6 ± 2.4, 4.1 ± 1.6, respectively) (P < 0.001). Mean pre-injection ODI was not significantly different between the groups (ODI: 20.9 ± 9.6 for Group 1, 25.2 ± 10.3 for Group 2). ODI values at 6 months for Group 1 and Group 2 were as follows: 12.8 ± 9.2, 14.3 ± 7.2, respectively) (P < 0.001). However, there were no significant differences between the groups. Similarly, there was no significant difference between the 2 groups on any of these parameters.

LIMITATIONS

A limited number of patients and limited follow-up time.

CONCLUSION

This study showed that intradiscal ozone injection alone was sufficient to treat low back and leg pain caused by LDH and that periforaminal steroid injection does not provide additional benefit, which is contrary to the literature.

摘要

背景

椎间盘内臭氧治疗是一种微创技术,适用于因退行性椎间盘引起的腰椎间盘突出症(LDH)导致的腰痛而对标准保守治疗无反应的患者。许多关于临床疗效的研究缺乏标准化的注射方法,并且受到研究设计不足的限制。

目的

本研究旨在确定经皮椎间孔内类固醇注射联合椎间盘内臭氧治疗的疗效。

研究设计

前瞻性、双盲、随机对照试验。

设置

三级护理中心。

方法

本研究纳入了 65 例因 LDH 引起腰痛和下肢痛的患者。第 1 组接受椎间盘内臭氧治疗(n=35),第 2 组接受椎间盘内臭氧治疗联合经皮椎间孔内类固醇注射(n=30)。使用视觉模拟量表(VAS)评估疼痛,使用 Oswestry 残疾指数(ODI)评估残疾,使用简短 36 健康调查(SF-36)评估生活质量,所有患者在注射前和注射后 1 个月和 6 个月进行评估。所有程序均在无菌条件下使用 C 臂透视机进行。

结果

与注射前相比,两组患者在治疗后疼痛、残疾和生活质量均有显著改善。两组患者的平均注射前 VAS 无显著差异(VAS:第 1 组 7.8±1.1,第 2 组 7.8±1.2)。第 1 组和第 2 组患者在 6 个月时的 VAS 值分别为:3.6±2.4、4.1±1.6(P<0.001)。两组患者的平均注射前 ODI 无显著差异(ODI:第 1 组 20.9±9.6,第 2 组 25.2±10.3)。第 1 组和第 2 组患者在 6 个月时的 ODI 值分别为:12.8±9.2、14.3±7.2(P<0.001)。然而,两组间无显著差异。同样,在这些参数上,两组之间也没有差异。

局限性

患者数量有限且随访时间有限。

结论

本研究表明,单独椎间盘内臭氧注射足以治疗 LDH 引起的腰痛和下肢痛,而经皮椎间孔内类固醇注射并不能带来额外的益处,这与文献报道相反。

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