Levi David, Tyszko Sara, Horn Scott, Pham Nicole, Levin Joshua
Jordan-Young Institute, Virginia Beach, VA, USA.
PM&R Section, Department of Orthopaedic Surgery and Neurosurgery, Stanford University, Redwood City, CA, USA.
Interv Pain Med. 2025 Jul 17;4(3):100611. doi: 10.1016/j.inpm.2025.100611. eCollection 2025 Sep.
The field of orthobiologics has attempted to address the challenge of discogenic low back pain (LBP). Research in areas such as stem cells, platelet-rich plasma, and specific growth factor injections has seen limited success.
The purpose of this trial was to determine the efficacy of a single intradiscal bone marrow concentrate (BMC) injection on pain and function for chronic discogenic LBP.
Patients with presumed discogenic LBP participated in a prospective, double-blind, randomized, sham controlled trial of a single intradiscal BMC injection compared to a sham procedure. Pain and function were assessed at baseline, 3, 6, and 12 months by Clinical Outcome Measurement Brief Instrument (COMBI) which includes the Numeric Rating Scale (NRS). Function was also assessed by the Oswestry Disability Index (ODI). The primary outcome was based upon clinical success, defined by at least 50 % pain relief from baseline to 3, 6, and 12 months.
Sixty-three patients were included in the trial (45 BMC, 18 sham). There were no significant differences in the primary outcome (>50 % relief in NRS) at 3 months (40 % BMC group [95 %CI: 27-50 %] vs 33 % sham group [95 %CI: 15-56 %]), 6 months (40 % BMC [95 %CI: 27-50 %] vs 39 % sham [95 %CI: 20-61 %]), or 12 months (44 % BMC [95 %CI: 31-59 %] vs 56 % sham [95 %CI: 34-75 %]). There were no significant differences in the proportion of patients achieving at least a 30 % improvement on the ODI at 3 months (51 % BMC group [95 %CI: 37-65 %] vs 33 % sham group [95 %CI: 16-56 %]), 6 months (53 % BMC [95 %CI: 39-67 %] vs 44 % sham [95 %CI: 25-65 %]), or 12 months (56 % BMC [95 %CI: 41-69 %] vs 61 % sham [95 %CI: 39-80 %]).
Intradiscal BMC was equivalent to a sham procedure for chronic discogenic LBP. Both groups had a high, but statistically equivalent success rate. Unfortunately, the significant limitations of this trial, including lack of quality cell analysis, limit the ability to draw conclusions on the effectiveness of intradiscal BMC.
骨科生物治疗领域一直试图应对椎间盘源性下腰痛（LBP）的挑战。在干细胞、富血小板血浆和特定生长因子注射等领域的研究取得的成功有限。
本试验的目的是确定单次椎间盘内骨髓浓缩物（BMC）注射对慢性椎间盘源性LBP的疼痛和功能的疗效。
疑似椎间盘源性LBP的患者参与了一项前瞻性、双盲、随机、假手术对照试验，将单次椎间盘内BMC注射与假手术进行比较。在基线、3个月、6个月和12个月时，通过临床结果测量简要工具（COMBI）评估疼痛和功能，该工具包括数字评分量表（NRS）。还通过Oswestry功能障碍指数（ODI）评估功能。主要结局基于临床成功，定义为从基线到3个月、6个月和12个月疼痛缓解至少50%。
63例患者纳入试验（45例BMC组，18例假手术组）。在3个月时（BMC组40%[95%CI：27-50%]对假手术组33%[95%CI：15-56%]）、6个月时（BMC组40%[95%CI：27-50%]对假手术组39%[95%CI：20-61%]）或12个月时（BMC组44%[95%CI：31-59%]对假手术组56%[95%CI：34-75%]），主要结局（NRS缓解>50%）无显著差异。在3个月时（BMC组51%[95%CI：37-65%]对假手术组33%[95%CI：16-56%]）、6个月时（BMC组53%[95%CI：39-67%]对假手术组44%[95%CI：25-65%]）或12个月时（BMC组56%[95%CI：41-69%]对假手术组61%[95%CI：39-80%]），ODI改善至少30%的患者比例无显著差异。
对于慢性椎间盘源性LBP，椎间盘内BMC与假手术等效。两组成功率都很高，但在统计学上相当。不幸的是，该试验存在重大局限性，包括缺乏高质量的细胞分析，限制了就椎间盘内BMC的有效性得出结论的能力。
