Lili Zhu, Yuanjie Sun, Jing Kang, Jun Liang, Tongsheng Su, Wenbin Fu, Wei Zhang, Rongshui Dai, Yan Hou, Hong Zhao, Weina Peng, Weiming Wang, Jing Zhou, Ruimin Jiao, Biyun Sun, Yan Yan, Yan Liu, Zhishun Liu
{"title":"针灸对退行性腰椎管狭窄症患者神经源性跛行的影响：随机临床试验。","authors":"Lili Zhu, Yuanjie Sun, Jing Kang, Jun Liang, Tongsheng Su, Wenbin Fu, Wei Zhang, Rongshui Dai, Yan Hou, Hong Zhao, Weina Peng, Weiming Wang, Jing Zhou, Ruimin Jiao, Biyun Sun, Yan Yan, Yan Liu, Zhishun Liu","doi":"10.7326/M23-2749","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Acupuncture may improve degenerative lumbar spinal stenosis (DLSS), but evidence is insufficient.</p><p><strong>Objective: </strong>To investigate the effect of acupuncture for DLSS.</p><p><strong>Design: </strong>Multicenter randomized clinical trial. (ClinicalTrials.gov: NCT03784729).</p><p><strong>Setting: </strong>5 hospitals in China.</p><p><strong>Participants: </strong>Patients with DLSS and predominantly neurogenic claudication pain symptoms.</p><p><strong>Intervention: </strong>18 sessions of acupuncture or sham acupuncture (SA) over 6 weeks, with 24-week follow-up after treatment.</p><p><strong>Measurements: </strong>The primary outcome was change from baseline in the modified Roland-Morris Disability Questionnaire ([RMDQ] score range, 0 to 24; minimal clinically important difference [MCID], 2 to 3). Secondary outcomes were the proportion of participants achieving minimal (30% reduction from baseline) and substantial (50% reduction from baseline) clinically meaningful improvement per the modified RMDQ.</p><p><strong>Results: </strong>A total of 196 participants (98 in each group) were enrolled. The mean modified RMDQ score was 12.6 (95% CI, 11.8 to 13.4) in the acupuncture group and 12.7 (CI, 12.0 to 13.3) in the SA group at baseline, and decreased to 8.1 (CI, 7.1 to 9.1) and 9.5 (CI, 8.6 to 10.4) at 6 weeks, with an adjusted difference in mean change of -1.3 (CI, -2.6 to -0.03; <i>P </i>= 0.044), indicating a 43.3% greater improvement compared with SA. The between-group difference in the proportion of participants achieving minimal and substantial clinically meaningful improvement was 16.0% (CI, 1.6% to 30.4%) and 12.6% (CI, -1.0% to 26.2%) at 6 weeks. Three cases of treatment-related adverse events were reported in the acupuncture group, and 3 were reported in the SA group. All events were mild and transient.</p><p><strong>Limitation: </strong>The SA could produce physiologic effects.</p><p><strong>Conclusion: </strong>Acupuncture may relieve pain-specific disability among patients with DLSS and predominantly neurogenic claudication pain symptoms, although the difference with SA did not reach MCID. The effects may last 24 weeks after 6-week treatment.</p><p><strong>Primary funding source: </strong>2019 National Administration of Traditional Chinese Medicine \"Project of building evidence-based practice capacity for TCM-Project BEBPC-TCM\" (NO. 2019XZZX-ZJ).</p>","PeriodicalId":7932,"journal":{"name":"Annals of Internal Medicine","volume":null,"pages":null},"PeriodicalIF":19.6000,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Effect of Acupuncture on Neurogenic Claudication Among Patients With Degenerative Lumbar Spinal Stenosis : A Randomized Clinical Trial.\",\"authors\":\"Lili Zhu, Yuanjie Sun, Jing Kang, Jun Liang, Tongsheng Su, Wenbin Fu, Wei Zhang, Rongshui Dai, Yan Hou, Hong Zhao, Weina Peng, Weiming Wang, Jing Zhou, Ruimin Jiao, Biyun Sun, Yan Yan, Yan Liu, Zhishun Liu\",\"doi\":\"10.7326/M23-2749\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Acupuncture may improve degenerative lumbar spinal stenosis (DLSS), but evidence is insufficient.</p><p><strong>Objective: </strong>To investigate the effect of acupuncture for DLSS.</p><p><strong>Design: </strong>Multicenter randomized clinical trial. (ClinicalTrials.gov: NCT03784729).</p><p><strong>Setting: </strong>5 hospitals in China.</p><p><strong>Participants: </strong>Patients with DLSS and predominantly neurogenic claudication pain symptoms.</p><p><strong>Intervention: </strong>18 sessions of acupuncture or sham acupuncture (SA) over 6 weeks, with 24-week follow-up after treatment.</p><p><strong>Measurements: </strong>The primary outcome was change from baseline in the modified Roland-Morris Disability Questionnaire ([RMDQ] score range, 0 to 24; minimal clinically important difference [MCID], 2 to 3). Secondary outcomes were the proportion of participants achieving minimal (30% reduction from baseline) and substantial (50% reduction from baseline) clinically meaningful improvement per the modified RMDQ.</p><p><strong>Results: </strong>A total of 196 participants (98 in each group) were enrolled. The mean modified RMDQ score was 12.6 (95% CI, 11.8 to 13.4) in the acupuncture group and 12.7 (CI, 12.0 to 13.3) in the SA group at baseline, and decreased to 8.1 (CI, 7.1 to 9.1) and 9.5 (CI, 8.6 to 10.4) at 6 weeks, with an adjusted difference in mean change of -1.3 (CI, -2.6 to -0.03; <i>P </i>= 0.044), indicating a 43.3% greater improvement compared with SA. The between-group difference in the proportion of participants achieving minimal and substantial clinically meaningful improvement was 16.0% (CI, 1.6% to 30.4%) and 12.6% (CI, -1.0% to 26.2%) at 6 weeks. Three cases of treatment-related adverse events were reported in the acupuncture group, and 3 were reported in the SA group. All events were mild and transient.</p><p><strong>Limitation: </strong>The SA could produce physiologic effects.</p><p><strong>Conclusion: </strong>Acupuncture may relieve pain-specific disability among patients with DLSS and predominantly neurogenic claudication pain symptoms, although the difference with SA did not reach MCID. The effects may last 24 weeks after 6-week treatment.</p><p><strong>Primary funding source: </strong>2019 National Administration of Traditional Chinese Medicine \\\"Project of building evidence-based practice capacity for TCM-Project BEBPC-TCM\\\" (NO. 2019XZZX-ZJ).</p>\",\"PeriodicalId\":7932,\"journal\":{\"name\":\"Annals of Internal Medicine\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":19.6000,\"publicationDate\":\"2024-08-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Annals of Internal Medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.7326/M23-2749\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/7/2 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Annals of Internal Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.7326/M23-2749","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/7/2 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
Participants: Patients with DLSS and predominantly neurogenic claudication pain symptoms.
Intervention: 18 sessions of acupuncture or sham acupuncture (SA) over 6 weeks, with 24-week follow-up after treatment.
Measurements: The primary outcome was change from baseline in the modified Roland-Morris Disability Questionnaire ([RMDQ] score range, 0 to 24; minimal clinically important difference [MCID], 2 to 3). Secondary outcomes were the proportion of participants achieving minimal (30% reduction from baseline) and substantial (50% reduction from baseline) clinically meaningful improvement per the modified RMDQ.
Results: A total of 196 participants (98 in each group) were enrolled. The mean modified RMDQ score was 12.6 (95% CI, 11.8 to 13.4) in the acupuncture group and 12.7 (CI, 12.0 to 13.3) in the SA group at baseline, and decreased to 8.1 (CI, 7.1 to 9.1) and 9.5 (CI, 8.6 to 10.4) at 6 weeks, with an adjusted difference in mean change of -1.3 (CI, -2.6 to -0.03; P = 0.044), indicating a 43.3% greater improvement compared with SA. The between-group difference in the proportion of participants achieving minimal and substantial clinically meaningful improvement was 16.0% (CI, 1.6% to 30.4%) and 12.6% (CI, -1.0% to 26.2%) at 6 weeks. Three cases of treatment-related adverse events were reported in the acupuncture group, and 3 were reported in the SA group. All events were mild and transient.
Limitation: The SA could produce physiologic effects.
Conclusion: Acupuncture may relieve pain-specific disability among patients with DLSS and predominantly neurogenic claudication pain symptoms, although the difference with SA did not reach MCID. The effects may last 24 weeks after 6-week treatment.
Primary funding source: 2019 National Administration of Traditional Chinese Medicine "Project of building evidence-based practice capacity for TCM-Project BEBPC-TCM" (NO. 2019XZZX-ZJ).
期刊介绍：
Established in 1927 by the American College of Physicians (ACP), Annals of Internal Medicine is the premier internal medicine journal. Annals of Internal Medicine’s mission is to promote excellence in medicine, enable physicians and other health care professionals to be well informed members of the medical community and society, advance standards in the conduct and reporting of medical research, and contribute to improving the health of people worldwide. To achieve this mission, the journal publishes a wide variety of original research, review articles, practice guidelines, and commentary relevant to clinical practice, health care delivery, public health, health care policy, medical education, ethics, and research methodology. In addition, the journal publishes personal narratives that convey the feeling and the art of medicine.
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