Chronic low back pain (CLBP) is a leading cause of disability worldwide and significantly impairs functional capacity and quality of life. Non-pharmacological therapies are recommended as first-line management, and acupuncture has demonstrated potential benefits in reducing pain and disability. Thread embedding acupuncture (TEA) is a modified acupuncture technique that provides prolonged stimulation through the implantation of absorbable polydioxanone (PDO) threads at acupuncture points.
This randomized controlled trial aims to evaluate the effectiveness of TEA at the EX-B2 points compared with sham TEA in improving disability and lumbar flexibility in patients with chronic non-specific low back pain. Disability will be assessed using the Oswestry Disability Index (ODI), and lumbar flexibility will be measured using the Finger-to-Floor Distance (FFD) test over an 8-week follow-up period.
Male or female participants aged ≥ 18 years
Participants experiencing low back pain for at least 3 months (>12 weeks)
Highest low back pain intensity within the past 2 weeks with a score of ≥ 3 on a 0-10 Numeric Pain Rating Scale (NPRS)
Receiving pharmacological therapy with a stable analgesic regimen for at least 2 weeks prior to enrollment
History of hypersensitivity reactions to acupuncture or thread embedding acupuncture, or known allergy to stainless steel or polydioxanone (PDO) threads
History of keloid formation
Presence of scars (cicatrices) or skin disorders at the thread embedding acupuncture insertion sites in the lower back area
Specific spinal pathology including fracture, tumor, infection, or severe lumbar spinal stenosis requiring surgical intervention