{"title":"Precision targeting in acupuncture: a pilot and feasibility study protocol of ultrasound-guided approach for non-specific low back pain.","authors":"Zihan Liu, Tianying Chang, Jili Fu, Hui Chi, Xiaodan Wang, Lisha Wang, Wenqi Cui, Yingzi Cui, Zhibin Cong","doi":"10.1186/s40814-025-01673-x","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Non-specific low back pain (NLBP) is increasingly prevalent in the world due to changes in lifestyle and work habits. It is found that the symptom is usually associated with damage in the thoracolumbar fascia (TLF) and its surrounding muscles. This paper introduces a pioneering approach for treating NLBP, using the heterogeneous echo zones on ultrasound images as needling targets, presenting a novel treatment protocol.</p><p><strong>Methods: </strong>An open randomized controlled trial is designed and conducted, in which 48 patients with NLBP will be randomly allocated at a ratio of one to one to an ultrasound-guided acupuncture (UGA) group and a regular acupuncture treatment (RA) group. The trial involves a 3-week treatment along with a follow-up for 3 weeks. Its primary purpose is to evaluate the feasibility and safety of ultrasound-guided acupuncture in the TLF and its adjacent muscles as a treatment method for NLBP. As its secondary objective, the treatment effectiveness will be assessed by observing the changes in the patient's pain level and low back dysfunction before and after treatment. The ultrasound-related parameters and adverse events will also be collected.</p><p><strong>Discussion: </strong>It is a novel therapeutic approach to treat NLBP with ultrasound-guided acupuncture performed in the TLF and its adjacent muscles, which is characterized by integrating acupuncture with ultrasound. This study is a single-site, open, randomized controlled study designed and conducted to evaluate the effectiveness of the method. If this strategy turns out to be safe and feasible, future in-depth and extensive research will be planned.</p><p><strong>Trial registration: </strong>International Traditional Medicine Clinical Trial Registry, ITMCTR2025000046. Registered on January 9, 2025. http://itmctr.ccebtcm.org.cn/.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"89"},"PeriodicalIF":1.5000,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12210429/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pilot and Feasibility Studies","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1186/s40814-025-01673-x","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
引用次数: 0
Abstract
Introduction: Non-specific low back pain (NLBP) is increasingly prevalent in the world due to changes in lifestyle and work habits. It is found that the symptom is usually associated with damage in the thoracolumbar fascia (TLF) and its surrounding muscles. This paper introduces a pioneering approach for treating NLBP, using the heterogeneous echo zones on ultrasound images as needling targets, presenting a novel treatment protocol.
Methods: An open randomized controlled trial is designed and conducted, in which 48 patients with NLBP will be randomly allocated at a ratio of one to one to an ultrasound-guided acupuncture (UGA) group and a regular acupuncture treatment (RA) group. The trial involves a 3-week treatment along with a follow-up for 3 weeks. Its primary purpose is to evaluate the feasibility and safety of ultrasound-guided acupuncture in the TLF and its adjacent muscles as a treatment method for NLBP. As its secondary objective, the treatment effectiveness will be assessed by observing the changes in the patient's pain level and low back dysfunction before and after treatment. The ultrasound-related parameters and adverse events will also be collected.
Discussion: It is a novel therapeutic approach to treat NLBP with ultrasound-guided acupuncture performed in the TLF and its adjacent muscles, which is characterized by integrating acupuncture with ultrasound. This study is a single-site, open, randomized controlled study designed and conducted to evaluate the effectiveness of the method. If this strategy turns out to be safe and feasible, future in-depth and extensive research will be planned.
Trial registration: International Traditional Medicine Clinical Trial Registry, ITMCTR2025000046. Registered on January 9, 2025. http://itmctr.ccebtcm.org.cn/.
期刊介绍：
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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