Costandi Shrif, Beall Douglas P, Davis Timothy T, Amirdelfan Kasra, Naidu Ramana K, DePalma Michael J, Yoon Edward S, Fleming Jacob W, Block Jon E, Mekhail Nagy
Pain Management, Cleveland Clinic, Cleveland, OH, USA.
Comprehensive Specialty Care, Edmond, OK, USA.
J Pain Res. 2025 Apr 9;18:1901-1908. doi: 10.2147/JPR.S516571. eCollection 2025.
The objective of this study was to determine the degree of improvement in lumbar discogenic pain severity and associated back impairment in patients with chronic axial low back pain treated with intradiscally delivered allogeneic nucleus pulposus (NP) at up to two vertebral levels (L1-S1).
Prospective, single-arm clinical study conducted at 6 sites in the US involving 28 participants with discogenic pain (mean age: 44 ± 13 yrs) and modified Pfirrmann grade 3-7 on magnetic resonance imaging. This report includes the final participant follow up at 24 months post procedure. Back pain severity was evaluated using an 11-point numeric rating scale (NRS) and back function using the Oswestry Disability Index (ODI). Minimal clinically important difference (MCID) and substantial clinical benefit (SCB) were set at ≥30% and ≥50% over baseline, respectively. The patient acceptable symptom state (PASS) threshold for pain severity was ≤3.
The average improvement in back pain severity from 7.1 ± 1.6 at baseline to 3.6 ± 2.9 at 24 months was 43% (p<0.001). Approximately 64% (14 of 22) of participants achieved both the MCID and SCB in back pain at 24 months, while nearly 55% (12 of 22) reported a 24-month back pain severity score of ≤3. The corresponding average decrease in ODI values was 53% (p<0.001) with 73% (16 of 22) of participants achieving the MCID. At baseline approximately 82% (23 of 28) of participants reported severe or crippled back impairment compared to 18% (4 of 22) at 24 months (p<0.001). There was no association between modified Pfirrmann grade, number of levels treated or Modic changes and any outcome (range: p=0.12 to 0.43).
This study provides evidence of clinically significant pain relief and functional improvement through 24 months of follow up after a single allogeneic NP supplementation procedure in patients with lumbar discogenic pain.
本研究的目的是确定在多达两个椎体节段（L1-S1）接受椎间盘内同种异体髓核（NP）治疗的慢性轴性下腰痛患者中，腰椎间盘源性疼痛严重程度及相关背部功能障碍的改善程度。
在美国6个地点进行的前瞻性单臂临床研究，纳入28例椎间盘源性疼痛患者（平均年龄：44±13岁），磁共振成像显示改良Pfirrmann分级为3-7级。本报告包括术后24个月对参与者的最终随访。使用11点数字评分量表（NRS）评估背痛严重程度，使用Oswestry功能障碍指数（ODI）评估背部功能。最小临床重要差异（MCID）和显著临床获益（SCB）分别设定为相对于基线提高≥30%和≥50%。疼痛严重程度的患者可接受症状状态（PASS）阈值为≤3。
背痛严重程度从基线时的7.1±1.6改善至24个月时的3.6±2.9，平均改善率为43%（p<0.001）。约64%（22例中的14例）参与者在24个月时背痛达到MCID和SCB，而近55%（22例中的12例）报告24个月时背痛严重程度评分≤3。ODI值相应的平均下降率为53%（p<0.001），73%（22例中的16例）参与者达到MCID。基线时约82%（28例中的23例）参与者报告有严重或致残性背部功能障碍，而24个月时为18%（22例中的4例）（p<0.001）。改良Pfirrmann分级、治疗节段数或Modic改变与任何结果之间均无关联（范围：p=0.12至0.43）。
本研究提供了证据，表明腰椎间盘源性疼痛患者在单次同种异体NP补充治疗后，经过24个月的随访，临床上有显著的疼痛缓解和功能改善。
