Beall Douglas P, Davis Timothy T, Amirdelfan Kasra, Naidu Ramana K, DePalma Michael J, Costandi Shrif, Fleming Jacob W, Yoon Edward S, Ganey Timothy, Block Jon E, Mekhail Nagy
Comprehensive Specialty Care, Edmond, OK.
Source Healthcare, Santa Monica, CA.
Pain Physician. 2024 Nov;27(8):E865-E871.
Preventing disc degeneration remains a clinical challenge; patients experiencing chronic lumbar discogenic pain have limited treatment options. Minimally invasive intradiscal procedures such as allogeneic nucleus pulposus (NP) injection have the potential to fill the treatment gap between failed conservative care and spine surgery.
Our study sought to evaluate the magnitude and durability of improvement in back function in patients with chronic lumbar discogenic pain followed for 6 months after a single intradiscal injection of minimally manipulated, off-the-shelf processed NP allograft (VIA Disc NP®, VIVEX Biologics, Inc.) at up to 2 vertebral levels.
Single-arm, prospective, multicenter, pilot study.
Academic and private practice outpatient clinics.
A total of 29 patients with symptomatic lumbar discogenic pain refractory to conservative care who had a back function score of 40-80 points on the Oswestry Disability Index (ODI), ≥ 6 on an 11-point back pain Numeric Rating Scale (NRS-11) and corresponding imaging evidence of disc degeneration were enrolled. A single dose, intradiscal injection of approximately 100 mg of NP allograft mixed with sterile saline was administered to the affected level or levels.
The average ODI and NRS-11 improvements between baseline and 6-months postprocedure were 54.8% (95% CI, 41.3-68.3) and 52.9% (95% CI, 34.7-71.1) respectively (P < 0.001). A minimal clinically important difference of ≥ 30% improvement over baseline was achieved in 79% (22 of 28) and 68% (19 of 28) of patients for ODI and NRS-11, respectively. At 6-months postprocedure, 64% (18 of 28) of patients had an NRS-11 score ≥ 3.
This pilot study did not employ a concurrent control group and the clinical follow-up was limited to 6 months.
These pilot findings demonstrate the feasibility of treating patients with symptomatic lumbar disc degeneration with a single intradiscal injection of allogeneic NP to provide significant and durable improvements in back function and pain.
预防椎间盘退变仍然是一项临床挑战；患有慢性腰椎间盘源性疼痛的患者治疗选择有限。微创椎间盘内手术，如异体髓核（NP）注射，有可能填补保守治疗失败与脊柱手术之间的治疗空白。
我们的研究旨在评估单次椎间盘内注射最少处理的即用型NP同种异体移植物（VIA Disc NP®，VIVEX Biologics公司）后，对多达2个椎体节段的慢性腰椎间盘源性疼痛患者进行6个月随访时，其背部功能改善的程度和持久性。
单臂、前瞻性、多中心、试点研究。
学术和私人执业门诊诊所。
总共纳入29例对保守治疗无效的有症状的腰椎间盘源性疼痛患者，这些患者在Oswestry功能障碍指数（ODI）上的背部功能评分为40 - 80分，在11分的背痛数字评定量表（NRS - 11）上得分≥6分，且有相应的椎间盘退变影像学证据。将约100mg的NP同种异体移植物与无菌生理盐水混合后，单次椎间盘内注射到受影响的一个或多个节段。
基线与术后6个月之间，平均ODI和NRS - 11的改善分别为54.8%（95%CI，41.3 - 68.3）和52.9%（95%CI，34.7 - 71.1）（P < 0.001）。ODI和NRS - 11分别有79%（28例中的22例）和68%（28例中的19例）的患者实现了比基线改善≥30%的最小临床重要差异。术后6个月时，64%（28例中的18例）的患者NRS - 11评分≥3。
这项试点研究未采用同期对照组，临床随访限于6个月。
这些试点研究结果表明，单次椎间盘内注射异体NP治疗有症状的腰椎间盘退变患者，可显著且持久地改善背部功能和疼痛，具有可行性。
