Non-specific Low Back Pain
Conditions
Interventions
Treatment group:Acupuncture Procedure: The patient was placed in a supine position. After disinfection with 75% alcohol, needles were inserted at the upper one-third of the umbilical wall. Centered on
Sham stimulation group:Sham Acupuncture Operation: The patient was placed in a supine position. After disinfection with 75% alcohol, a disposable foam pad was applied to the selected acupuncture point
the tip of the needle touched the skin surface but did not penetrate the skin. The duration of needle manipulation and retention was consistent with the treatment group. The treatment frequency was id
Healthy Control Group:"The acupuncture procedure and treatment frequency were identical to those of the treatment group
Sponsors
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
20 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients with Non-specific Low Back Pain (NSLBP) (1) Diagnostic Criteria: Based on the NSLBP diagnostic criteria in the Chinese Guidelines for the Diagnosis and Treatment of Chronic Low Back Pain (2024 Edition). (2) TCM Pattern Differentiation Criteria: 1) Pain characteristics: Soreness or dull pain in the lumbar region. 2) Aggravating and relieving factors: Aggravated by exertion/fatigue; relieved by lying down. (3) Inclusion Criteria: 1) Meet the aforementioned diagnostic criteria for NSLBP and TCM pattern differentiation criteria. 2) Aged 20–70 years, of any gender. 3) Disease duration of at least 3 months. 4) Visual Analog Scale (VAS) score > 3 at enrollment. 2. Healthy Control Group Inclusion Criteria: 1) Normal lumbar spine and function (confirmed by imaging or physical examination). 2) Age and gender matched with the treatment group (allowable range of ±10%). 3) Have not received acupuncture or similar treatments within the past week. 4) Good sleep quality within the past week. 5) Baseline assessment scores: HAMD < 8 and HAMA < 7. 6) No habit of strenuous exercise within the past month; maintain regular daily activities. 7) Understand and agree to participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with Non-specific Low Back Pain (Treatment Group and Sham Stimulation Group) Exclusion Criteria: 1) Patients with infectious lumbar spine diseases. 2) Severe diseases of the cardiovascular, liver, kidney, or hematopoietic systems; or failure of important organs. 3) History of cerebrovascular diseases or neurological diseases. 4) History of severe psychiatric disorders. 5) Regular use of analgesics (=3 times/week) within 3 weeks prior to enrollment, or temporary use of the aforementioned analgesics more than 2 times within 2 weeks prior to enrollment. 6) Local contraindications for acupuncture in the umbilical region, such as skin infection, skin damage, or unrepaired umbilical hernia. 7) Coagulation disorders (INR > 1.5 or APTT > 1.5 times the normal value). 8) Pregnant or lactating women, and those unable to cooperate with the trial. 9) Comorbidities that may significantly interfere with pain assessment, as judged by the investigator. 2. Healthy Control Group Exclusion Criteria: 1) History of cerebrovascular or neurological diseases. 2) History of severe psychiatric disorders. 3) Local contraindications for acupuncture in the umbilical region, such as skin infection, skin damage, or unrepaired umbilical hernia. 4) History of coagulation disorders (INR > 1.5 or APTT > 1.5 times the normal value). 5) Pregnant or lactating women, and those unable to cooperate with the trial. 6) History of needle fainting. 7) Any contraindications for EEG recording.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analog Scale,VAS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Oswestry Disability Index,ODI;Hamilton Depression Scale,HAMD;Hamilton anxiety scale, HAMA;Traditional Chinese Medicine Symptom Score;Resting-state Electroencephalogram;Clinical Efficacy of TCM Syndromes (Total Effective Rate); | — |
Countries
China
Contacts
Public ContactHua Xu Yun
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed