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/.