Chronic Nonspecific Low Back Pain
Conditions
Interventions
Sham Electroacupuncture Group:Sham Electroacupuncture. Detailed Description: Points: Same as the electroacupuncture group. Procedure: A disposable blunt-tip (non-penetrating) needle is used. The nee
Sponsors
Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
25 Years to 54 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria (1)Meet the diagnostic criteria for chronic nonspecific low back pain according to the 2020 NASS Evidence-Based Clinical Guidelines for the Diagnosis and Treatment of Low Back Pain and the 2022 Chinese Clinical Guidelines for the Diagnosis and Treatment of Nonspecific Low Back Pain; (2) Aged between 25 and 54 years (inclusive), regardless of gender; (3) Visual Analogue Scale (VAS) score for low back pain = 40 mm; (4) The participant provides informed consent, signs the informed consent form, and voluntarily agrees to participate in this study. Note: Participants must meet ALL of the above criteria to be enrolled in this study.
Exclusion criteria
Exclusion criteria: Exclusion Criteria (1) Presence of specific low back pain indicated by lumbar MRI/CT within the past 3 months, such as spinal tumors (primary or metastatic), vertebral fractures, spinal infections, spinal cord injury, myelitis, ankylosing spondylitis, or clinically significant spinal deformities (e.g., spondylolisthesis, spondylolysis, or scoliosis); (2) Clinical signs of cauda equina compression (e.g., saddle anesthesia, bladder or bowel dysfunction/incontinence, progressive lower limb weakness); (3) Abnormal cardiac, hepatic, or renal function, or serious systemic red flags (e.g., fever on most days over the past month; unexplained weight loss =5 kg recently); (4) Presence of widespread pain or radicular signs; (5) Unsuitable for electroacupuncture treatment, such as patients with a cardiac pacemaker, bleeding tendency or current use of anticoagulants (e.g., warfarin), history of needle syncope, history of lumbar 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 year; (7) Use of medications effective for chronic low back pain, such as glucocorticoids or nonsteroidal anti-inflammatory drugs (NSAIDs), within the past 4 weeks (patients may be re-screened after a washout period of 5 half-lives); (8) Severe mental disorders or cognitive impairments that hinder cooperation with treatment and evaluation; (9) Planned spinal surgery or other interventional treatments (e.g., glucocorticoid injections) during the trial period; (10) Pregnancy, lactation, or planned pregnancy. Note: Patients meeting ANY of the above criteria will be excluded from the study.
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);Self-Rating Anxiety Scale Score(SAS);Self-Rating Depression Scale Score (SDS) ; Patient Global Assessment (PGA);Rescue Medication Use;Patient Blinding Assessment (PBA);Incidence of adverse events (AEs); | — |
Countries
Kyrgyz Republic
Contacts
Public ContactGuo Yi
Tianjin University of Traditional Chinese Medicine
Outcome results
None listed