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
Parallel
Thread Embedding Acupuncture
DeviceParticipants will be randomly assigned in a 1:1 ratio to one of two parallel groups. The assigned procedures will be administered once, and outcomes will be evaluated over an 8-week follow-up period.
Sham Thread Embedding Acupuncture
DeviceParticipants will be randomly assigned in a 1:1 ratio to one of two parallel groups. The assigned procedures will be administered once, and outcomes will be evaluated over an 8-week follow-up period.
Change in Oswestry Disability Index (ODI)
The Oswestry Disability Index (ODI) is a validated questionnaire assessing disability related to low back pain. Scores range from 0 to 100, with higher scores indicating greater disability and worse functional status. A decrease in ODI score represents improvement in functional disability.
Change in Finger-to-Floor Distance (FFD)
The Finger-to-Floor Distance (FFD) assesses lumbar flexibility by measuring the distance (in centimeters) between the fingertips and the floor during maximal forward trunk flexion. Values range from 0 cm to higher positive values, with lower scores indicating better lumbar flexibility. A decrease in FFD represents improvement in lumbar flexibility.
Incidence and Type of Adverse Events Related to Thread Embedding Acupuncture
The incidence and type of adverse events related to thread embedding acupuncture will be recorded throughout the study period, including pain, bruising, swelling, infection, and other procedure-related complications. The number of participants experiencing at least one adverse event and the type of events will be summarized for each study group.
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