Chronic Nonspecific Low Back Pain
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria (1) Meet the diagnostic criteria for chronic nonspecific low back pain described above; (2) Aged 18 to 65 years (inclusive), with no gender restriction; (3) Low back pain Visual Analogue Scale (VAS) score = 40 mm; (4) The subject has been informed of the study details, signs the informed consent form, and voluntarily agrees to participate in this study.
Exclusion criteria
Exclusion criteria: Exclusion Criteria (1) Presence of specific low back pain indicated by lumbar MRI/CT within 3 months, including spinal tumors (primary or metastatic), vertebral fractures, spinal infection, spinal cord injury, myelitis, ankylosing spondylitis, or clinically significant spinal deformities (spondylolisthesis, spondylolysis, or scoliosis); (2) Clinical signs of cauda equina compression (e.g., saddle area paresthesia, bowel or bladder dysfunction or incontinence, progressive lower limb weakness, etc.); (3) Abnormal heart, liver, or kidney function, or serious general warning signs (fever on most days in the past month; unexplained weight loss of 5 kg or more in the recent period); (4) Presence of widespread pain or radicular signs; (5) Presence of conditions unsuitable for electroacupuncture treatment, such as implanted cardiac pacemaker, bleeding tendency or current use of anticoagulant medications (e.g., warfarin), history of needle phobia, history of lumbar spine surgery (including discectomy, fusion, etc.), or uncontrolled epilepsy; (6) Receipt of any form of acupuncture (including manual acupuncture, electroacupuncture, etc.) for chronic low back pain within the past 1 year; (7) Use of glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDs), or other medications with therapeutic effects on chronic low back pain within the past 4 weeks (patients may be rescreened after a washout period of 5 half-lives); (8) Presence of local skin lesions, infection, dermatitis, or allergy to electrode pad adhesive, making the patient unsuitable for transcutaneous electrical acupoint stimulation; (9) Presence of severe mental illness or cognitive impairment that precludes cooperation with treatment and evaluation; (10) Planned spinal surgery or other interventional procedures (e.g., glucocorticoid injections) during the trial treatment period; (11) Women who are pregnant, lactating, or planning to become pregnant. Note: Patients meeting any of the above criteria will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale (VAS) for Low Back Pain; | — |
Secondary
| Measure | Time frame |
|---|---|
| Roland-Morris Disability Questionnaire Score (RMDQ);Oswestry Disability Index Score (ODI) ;36-Item Short Form Health Survey Score (SF-36);Fear-Avoidance Beliefs Questionnaire (FABQ);Patient Global Assessment (PGA);Rescue Medication Use;Incidence of adverse events (AEs);Functional near-infrared spectroscopy (fNIRS); | — |
Countries
China
Contacts
Tianjin Binhai New Area Hospital of Traditional Chinese Medicine