Schaufele Michael K
Emory Spine Center--Physical Medicine and Rehabilitation, Pain Medicine, Atlanta, Georgia 30329, USA.
Pain Med. 2008 Oct;9(7):835-43. doi: 10.1111/j.1526-4637.2008.00516.x.
Single-arm prospective clinical trial.
To determine the treatment effect and MRI changes of targeted disc decompression using an intradiscal catheter for focal heating of symptomatic lumbar disc protrusions resulting in radicular pain.
Percutaneous methods for treatment of lumbar disc herniations are potentially attractive alternatives to open surgical discetomies. The effects of a newly designed, percutaneous electrothermal intradiscal catheter were evaluated.
Twenty-two subjects with MRI confirmed, single-level contained lumbar disc protrusions, a minimum of 8 weeks of radicular pain (average 63 weeks) and failed nonsurgical treatment were invited. Nineteen patients underwent the decompression procedure. Follow-up was performed by physical exam and pain severity visual analog scale (VAS), SF-36 bodily pain (BP)/physical functioning (PF) scores for 12 months post-procedure. MRIs were obtained prior to treatment and at 3 months post-procedure.
Eighty-four percent of treated patients were available for follow-up at 12 months. The mean reduction in leg pain VAS scores was 2.6 points (40.6%, 95% CI 1.0-4.1). The mean reduction in back pain VAS scores was 2.4 points (44.4%, 95% CI 0.8-4.0). SF-36 BP scores improved 28.8 points (95% CI 17.5-40.0) and SF-36 PF scores improved 25.4 points (95% CI 13.0-37.7) on average. Effect sizes were small for VAS scores and moderate for SF-36 scores. Fifty-four percent of disc herniations were improved or resolved on MRI. No device-related or intraoperative complications were observed.
Targeted disc decompression provided moderate improvement in leg pain and function in the majority of patients with chronic radicular pain.
单臂前瞻性临床试验。
确定使用椎间盘内导管对有症状的腰椎间盘突出症进行局部加热以缓解神经根性疼痛的靶向椎间盘减压治疗效果及MRI变化。
经皮治疗腰椎间盘突出症的方法是开放性手术椎间盘切除术潜在的有吸引力的替代方案。对一种新设计的经皮电热椎间盘内导管的效果进行了评估。
邀请了22名经MRI证实为单节段包容性腰椎间盘突出症、神经根性疼痛至少8周（平均63周）且非手术治疗失败的受试者。19名患者接受了减压手术。术后12个月通过体格检查、疼痛严重程度视觉模拟量表（VAS）、SF-36身体疼痛（BP）/身体功能（PF）评分进行随访。在治疗前和术后3个月进行MRI检查。
84%的治疗患者在12个月时可进行随访。腿部疼痛VAS评分平均降低2.6分（40.6%，95%可信区间1.0 - 4.1）。背部疼痛VAS评分平均降低2.4分（44.4%，95%可信区间0.8 - 4.0）。SF-36 BP评分平均提高28.8分（95%可信区间17.5 - 40.0），SF-36 PF评分平均提高25.4分（95%可信区间13.0 - 37.7）。VAS评分的效应量较小，SF-36评分的效应量中等。54%的椎间盘突出症在MRI上得到改善或缓解。未观察到与器械相关或术中并发症。
靶向椎间盘减压使大多数慢性神经根性疼痛患者的腿部疼痛和功能得到中度改善。
