Effect of Thread-Embedding Acupuncture at EX-B2 on Pain and Quality of Life in Chronic Low Back Pain

Overview

The goal of this clinical trial is to learn whether thread-embedding acupuncture (TEA) is more effective than sham thread-embedding acupuncture in treating adults with chronic low back pain. The study will also evaluate the safety of TEA. The main questions it aims to answer are: * Does TEA reduce pain intensity more effectively than sham TEA? * Does TEA improve quality of life compared with sham TEA? * Does TEA reduce the frequency of bothersome pain episodes? * Does TEA reduce the use of routine and additional (extra) pain medications? * What side effects occur in participants receiving TEA compared with sham TEA? Researchers will compare TEA with sham TEA (a procedure that mimics acupuncture without needle insertion or thread placement) to determine whether TEA provides greater and longer-lasting benefits for chronic low back pain. Participants will: * Receive a single session of TEA or sham TEA * Continue using pain medications as prescribed by their physician * Be evaluated at weeks 2, 4, 6, and 8 after treatment * Complete pain assessments, quality-of-life questionnaires, and reports of pain episodes and medication use * Attend in-person clinic visits at weeks 4 and 8, and receive telephone follow-ups at weeks 2 and 6

* In the intervention group, thread-embedding acupuncture is performed using needles containing polydioxanone (PDO) threads at the bilateral lumbar EX-B2 acupuncture points (12.5 mm lateral to the spinous process). * In the control group, the needle is only touched to the skin at the acupuncture point area without skin penetration. * The selection of the EX-B2 level is based on the vertebral segment from L1 to L5 that best corresponds to the subject's dominant pain location, with reference to dermatome and myotome mapping as well as the concept of lumbar segmental innervation. If available, supporting examination results (e.g., MRI or CT scan) indicating abnormalities at a specific segment are used as additional references. When more than one segment is considered possible, the midpoint level is selected. * After completion of the study, participants in the sham thread-embedding acupuncture group are allowed to receive actual thread-embedding acupuncture therapy for chronic low back pain. Outcome Definitions \- Bothersome pain episodes: The number of days in the past 7 days during which the subject experienced bothersome low back pain. Bothersome low back pain is defined as pain that is sufficiently significant to interfere with daily activities, rest, concentration, or overall comfort. Mild pain or pain that does not interfere with activities is not counted. \- Frequency of routine analgesic use: The number of days in the past 7 days during which the subject consumed routine analgesic medication (taken as prescribed by a physician). Routine analgesics may include primary analgesics (paracetamol and/or opioids) and/or adjuvant analgesics (muscle relaxants, antiepileptics, antidepressants, antispasmodics). \- Frequency of additional (rescue) analgesic use: The number of days in the past 7 days during which the subject consumed additional (as-needed) analgesic medication when pain remained bothersome. Additional analgesics may include primary analgesics (paracetamol and/or opioids) and/or adjuvant analgesics (muscle relaxants, antiepileptics, antidepressants, antispasmodics).