高强度激光联合胶原酶化学核溶解治疗腰椎间盘突出症的疗效:一项前瞻性随机对照试验。

IF 3.3 2区 医学 Q1 CLINICAL NEUROLOGY
Pain and Therapy Pub Date : 2025-08-01 Epub Date: 2025-06-12 DOI:10.1007/s40122-025-00756-0
Peng Song, Chao Ma, Chenchen Xu, Yongjun Zhang, Yan Yuan
{"title":"高强度激光联合胶原酶化学核溶解治疗腰椎间盘突出症的疗效:一项前瞻性随机对照试验。","authors":"Peng Song, Chao Ma, Chenchen Xu, Yongjun Zhang, Yan Yuan","doi":"10.1007/s40122-025-00756-0","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":19908,"journal":{"name":"Pain and Therapy","volume":" ","pages":"1379-1398"},"PeriodicalIF":3.3000,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12279629/pdf/","citationCount":"0","resultStr":"{\"title\":\"Efficacy of Combined High-Intensity Laser Therapy and Collagenase Chemonucleolysis in Lumbar Disc Herniation Management: a Prospective Randomized Controlled Trial.\",\"authors\":\"Peng Song, Chao Ma, Chenchen Xu, Yongjun Zhang, Yan Yuan\",\"doi\":\"10.1007/s40122-025-00756-0\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>\",\"PeriodicalId\":19908,\"journal\":{\"name\":\"Pain and Therapy\",\"volume\":\" \",\"pages\":\"1379-1398\"},\"PeriodicalIF\":3.3000,\"publicationDate\":\"2025-08-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12279629/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Pain and Therapy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s40122-025-00756-0\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/6/12 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pain and Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s40122-025-00756-0","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/6/12 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
引用次数: 0

摘要

腰椎间盘突出症(LDH)是一种常见的退行性脊柱疾病。虽然胶原酶化学核溶解对LDH的长期治疗是有效的,但延迟症状缓解仍然是一个限制。最近的研究表明,高强度激光治疗(HILT)可能增强组织修复和疼痛调节,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HILT联合胶原酶化学核溶解术是否能加速腰椎间盘突出症患者术后早期恢复。方法:该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。这项单中心、单盲随机对照试验最终招募了60名符合条件的腰椎间盘突出症患者;采用计算机生成的随机顺序,按1:1分配,将参与者随机分配到实验组(HILT +胶原酶)或对照组(仅胶原酶)。在干预开始之前,小组作业被隐藏在密封的不透明信封中。所有的参与者都接受了胶原酶化学核溶解,对照组接受标准的术后护理联合假激光治疗,而实验组在常规治疗的同时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,而次要终点包括Oswestry残疾指数(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,并在五个预定义的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。采用SPSS 20.0进行统计学分析。连续变量的比较采用独立t检验或Mann-Whitney U检验,分类变量的分析采用卡方检验。结果:共60例患者(每组30例)完成研究,平均年龄为57.15±9.18岁。年龄、性别、体重指数(BMI)、疝程度、症状持续时间等基线特征组间差异无统计学意义(P < 0.05)。在年龄(58.00±7.13岁vs 57.06±9.08岁)、性别分布(男性:53.3% vs 50.0%)或病程(5.17±3.45个月vs 5.73±3.07个月)方面,两组间基线差异无统计学意义(P < 0.05)。结果显示,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残疾指数(ODI)评分和SF-36生活质量评分方面均明显优于对照组(均P)。我们的研究结果表明,高强度激光治疗增强胶原酶化学核溶解术可显著改善腰椎间盘突出症患者术后早期疼痛和功能预后。然而,治疗优势在3个月后减弱,这表明这种联合治疗主要是加速早期恢复,而不是改变长期预后。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Efficacy of Combined High-Intensity Laser Therapy and Collagenase Chemonucleolysis in Lumbar Disc Herniation Management: a Prospective Randomized Controlled Trial.

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.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Pain and Therapy
Pain and Therapy CLINICAL NEUROLOGY-
CiteScore
6.60
自引率
5.00%
发文量
110
审稿时长
6 weeks
期刊介绍: Pain and Therapy is an international, open access, peer-reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of pain therapies and pain-related devices. Studies relating to diagnosis, pharmacoeconomics, public health, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to, acute pain, cancer pain, chronic pain, headache and migraine, neuropathic pain, opioids, palliative care and pain ethics, peri- and post-operative pain as well as rheumatic pain and fibromyalgia. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports, trial protocols, short communications such as commentaries and editorials, and letters. The journal is read by a global audience and receives submissions from around the world. Pain and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信