骨髓浓缩液椎间盘内注射治疗慢性椎间盘源性腰痛：一项双盲随机假对照试验

Interventional Pain Medicine Pub Date : 2025-07-17 DOI:10.1016/j.inpm.2025.100611

David Levi , Sara Tyszko , Scott Horn , Nicole Pham , Joshua Levin

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引用次数: 0

摘要

背景概述骨科领域试图解决椎间盘源性腰痛（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了有限的成功。目的探讨单次椎间盘内骨髓浓缩液（BMC）注射对慢性盘源性腰痛的镇痛作用。方法假定椎间盘源性腰痛患者参加了一项前瞻性、双盲、随机、假对照试验，与假手术相比，单次椎间盘内BMC注射。疼痛和功能在基线、3、6和12个月通过临床结果测量简短工具（COMBI）进行评估，其中包括数字评定量表（NRS）。并用Oswestry残疾指数（ODI）评估功能。主要结局是基于临床成功，定义为从基线到3,6和12个月至少有50%的疼痛缓解。结果共纳入63例患者（BMC组45例，假手术组18例）。3个月（40% BMC组[95% CI: 27 - 50%] vs 33%假手术组[95% CI: 15 - 56%]）、6个月（40% BMC组[95% CI: 27 - 50%] vs 39%假手术组[95% CI: 20 - 61%]）或12个月（44% BMC组[95% CI: 31 - 59%] vs 56%假手术组[95% CI: 34 - 75%]）的主要结局（NRS缓解>； 50%）无显著差异。3个月（51% BMC组[95% CI: 37 - 65%] vs 33%假手术组[95% CI: 16 - 56%]）、6个月（53% BMC组[95% CI: 39 - 67%] vs 44%假手术组[95% CI: 25 - 65%]）或12个月（56% BMC组[95% CI: 41 - 69%] vs 61%假手术组[95% CI: 39 - 80%]）的患者比例无显著差异。结论椎间盘下基底区BMC等同于假手术治疗慢性椎间盘源性腰痛。两组的成功率都很高，但在统计学上是相等的。不幸的是，该试验的重大局限性，包括缺乏高质量的细胞分析，限制了对椎间盘内BMC有效性得出结论的能力。

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Bone marrow concentrate intradiscal injection for chronic discogenic low back pain: A double-blind randomized sham-controlled trial

Summary of background

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.

Objective

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.

Methods

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.

Results

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 %]).

Conclusions

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.

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Interventional Pain Medicine

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