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高强度激光疗法联合胶原酶化学溶核术治疗腰椎间盘突出症的疗效:一项前瞻性随机对照试验。

Efficacy of Combined High-Intensity Laser Therapy and Collagenase Chemonucleolysis in Lumbar Disc Herniation Management: a Prospective Randomized Controlled Trial.

作者信息

Song Peng, Ma Chao, Xu Chenchen, Zhang Yongjun, Yuan Yan

机构信息

Department of Pain, The Third Affiliated Hospital to Soochow University, No. 185, Juqian Street, Changzhou, 213003, China.

出版信息

Pain Ther. 2025 Jun 12. doi: 10.1007/s40122-025-00756-0.

Abstract

INTRODUCTION

Lumbar disc herniation (LDH) is a prevalent degenerative spinal disorder. While collagenase chemonucleolysis is effective in long-term LDH management, delayed symptom relief remains a limitation. Recent studies suggest that high-intensity laser therapy (HILT) may enhance tissue repair and pain modulation, providing a rationale for exploring its synergistic effects with collagenase therapy. This study aimed to investigate whether combining HILT with collagenase chemonucleolysis could accelerate early postoperative recovery in patients with lumbar disc herniation.

METHODS

This single-blind randomized controlled trial was conducted at the Department of Pain Management, The First People's Hospital of Changzhou, between October 2023 and October 2024. This single-center, single-blind randomized controlled trial finally enrolled 60 eligible patients with lumbar disc herniation; participants were randomly assigned to the experimental (HILT + collagenase) or control (collagenase alone) group using a computer-generated randomization sequence with 1:1 allocation. Group assignments were concealed in sealed opaque envelopes until intervention initiation. All participants underwent collagenase chemonucleolysis, with the control group receiving standard postoperative care combined with sham laser therapy, while the experimental group received additional high-intensity laser irradiation alongside conventional treatment. The primary endpoints comprised visual analog scale (VAS) pain scores and clinical efficacy rates evaluated using modified MacNab criteria, while secondary outcomes included the Oswestry Disability Index (ODI), straight-leg-raising angle measurements, and 36-Item Short Form Health Survey (SF-36) quality of life assessments, with standardized evaluations conducted at five predefined intervals: preoperative baseline, 1 week, 1 month, 3 months, and 6 months postoperatively. Statistical analyses were performed using SPSS 20.0. Continuous variables were compared via independent t-tests or Mann-Whitney U tests, while categorical variables were analyzed using chi-squared tests. All tests were two-tailed, with P < 0.05 considered statistically significant.

RESULTS

A total of 60 patients (30 per group) with a mean age of 57.15 ± 9.18 years completed the study. Baseline characteristics including age, gender, body mass index (BMI), herniation level, and symptom duration showed no significant intergroup differences (all P > 0.05). No significant baseline differences were observed between groups regarding age (58.00 ± 7.13 versus 57.06 ± 9.08 years), gender distribution (male: 53.3% versus 50.0%), or disease duration (5.17 ± 3.45 versus 5.73 ± 3.07 months) (all P > 0.05). The results showed that there was no statistically significant difference in baseline data between the two groups of patients. At 1 week and 1 month postoperatively, the experimental group demonstrated significantly better outcomes compared with the control group in terms of pain VAS scores, excellent/good rate, Oswestry Disability Index (ODI) scores, and Short Form 36 (SF-36) quality of life scores (all P < 0.05). However, at 3 and 6 months postoperatively, no significant differences were observed between the two groups. The lack of sustained intergroup differences is supported by small effect sizes (Cohen's d = 0.15 for ODI at 3 months; 95% CI: [-2.74, 0.74]) and overlapping confidence intervals in SF-36 domains, indicating that HILT's therapeutic impact is clinically meaningful only during the early inflammatory phase, with diminishing relevance as collagenase-mediated remodeling dominates long-term recovery.

CONCLUSIONS

Our findings demonstrate that high-intensity laser therapy augmentation of collagenase chemonucleolysis significantly improves early postoperative pain and functional outcomes in patients with lumbar disc herniation. However, the therapeutic advantage diminishes by 3 months, suggesting this combination therapy primarily accelerates early recovery rather than altering long-term prognosis.

摘要

引言

腰椎间盘突出症(LDH)是一种常见的脊柱退行性疾病。虽然胶原酶化学溶解术在腰椎间盘突出症的长期治疗中有效,但症状缓解延迟仍是一个限制因素。最近的研究表明,高强度激光治疗(HILT)可能会增强组织修复和疼痛调节,这为探索其与胶原酶治疗的协同作用提供了理论依据。本研究旨在探讨高强度激光治疗与胶原酶化学溶解术联合应用是否能加速腰椎间盘突出症患者术后的早期恢复。

方法

本单盲随机对照试验于2023年10月至2024年10月在常州市第一人民医院疼痛管理科进行。本单中心、单盲随机对照试验最终纳入了60例符合条件的腰椎间盘突出症患者;使用计算机生成的随机序列以1:1的比例将参与者随机分配到实验组(HILT+胶原酶)或对照组(仅胶原酶)。组分配被密封在不透明信封中,直到开始干预。所有参与者均接受胶原酶化学溶解术,对照组接受标准术后护理并联合假激光治疗,而实验组在常规治疗的基础上接受额外的高强度激光照射。主要终点包括视觉模拟量表(VAS)疼痛评分和使用改良MacNab标准评估的临床有效率,次要结果包括Oswestry功能障碍指数(ODI)、直腿抬高角度测量和36项简短健康调查(SF-36)生活质量评估,在五个预定义的时间间隔进行标准化评估:术前基线、术后1周、1个月、3个月和6个月。使用SPSS 20.0进行统计分析。连续变量通过独立t检验或Mann-Whitney U检验进行比较,分类变量使用卡方检验进行分析。所有检验均为双侧检验,P<0.05被认为具有统计学意义。

结果

共有60例患者(每组30例)完成了研究,平均年龄为57.15±9.18岁。包括年龄、性别、体重指数(BMI)、突出水平和症状持续时间在内的基线特征在组间无显著差异(所有P>0.05)。在年龄(58.00±7.13岁对57.06±9.08岁)、性别分布(男性:53.3%对50.0%)或病程(5.17±3.45个月对5.73±3.07个月)方面,两组之间未观察到显著的基线差异(所有P>0.05)。结果表明,两组患者的基线数据无统计学差异。术后1周和1个月,实验组在疼痛VAS评分、优/良率、Oswestry功能障碍指数(ODI)评分和简短健康调查36项(SF-36)生活质量评分方面的结果明显优于对照组(所有P<0.05)。然而,在术后3个月和6个月,两组之间未观察到显著差异。效应量较小(3个月时ODI的Cohen's d=0.15;95%CI:[-2.74, 0.74])以及SF-36各领域的置信区间重叠,支持了组间差异缺乏持续性,表明高强度激光治疗的治疗效果仅在早期炎症阶段具有临床意义,随着胶原酶介导的重塑在长期恢复中占主导地位,其相关性逐渐降低。

结论

我们的研究结果表明,高强度激光治疗增强胶原酶化学溶解术可显著改善腰椎间盘突出症患者术后早期的疼痛和功能结果。然而,治疗优势在3个月时减弱,表明这种联合治疗主要加速早期恢复,而不是改变长期预后。

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