None listed
Conditions
Interventions
Procedure/Surgery : The intervention group (herbal medicine strategy group) is part of a pragmatic randomized controlled trial designed to evaluate the effectiveness of a herbal medicine-based treatme
Sponsors
Jaseng Hospital of Korean Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Presence of low back pain persisting for more than 3 months ? Numeric Rating Scale (NRS) score for low back pain of 5 or higher ? Patients aged 19 years or older and younger than 70 years ? Individuals who agree to participate in the clinical trial and provide written informed consent
Exclusion criteria
Exclusion criteria: ? Diagnosed with serious specific conditions that may cause low back pain or radiating leg pain (e.g., spinal metastasis of tumors, acute fractures, or spinal dislocations) ? Presence of progressive neurological deficits or severe neurological symptoms ? Pain originating from soft tissue disorders rather than the spine (e.g., tumors, fibromyalgia, rheumatoid arthritis, gout) ? Presence of other chronic diseases that may interfere with treatment efficacy or interpretation of outcomes (e.g., stroke, myocardial infarction, kidney disease, diabetic neuropathy, dementia, epilepsy) ? Currently taking steroids, immunosuppressants, psychiatric medications, or other drugs that may affect study results ? Unsuitable or unsafe for acupuncture treatment: individuals with bleeding disorders, receiving anticoagulant therapy, or those with severe diabetes at risk of infection ? Unsuitable or unsafe for herbal medicine treatment: individuals with conditions affecting drug absorption or with gastrointestinal disorders after related surgeries, or with severe liver or kidney disease (AST, ALT, ?-GTP, or serum creatinine = 2 times the upper normal limit at screening) ? Use of medications that may affect pain (e.g., NSAIDs) or acupuncture treatment within the past 7 days ? Pregnant women, those planning pregnancy, or breastfeeding mothers ? History of lumbar spine surgery within the past 3 months ? Participation in another clinical trial within the past month, or plans to participate in another trial during the study or follow-up period (within 6 months of enrollment) ? Difficulty providing written informed consent ? Any other condition that, in the investigator’s judgment, makes participation in the clinical trial inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Low back pain Numeric Rating Scale, NRS;Oswestry Disability Index, ODI | — |
Secondary
| Measure | Time frame |
|---|---|
| 5-Level EuroQol-5 Dimension, EQ-5D-5L;Health-related Quality of Life Instrument with 8 Items, HINT-8;Patient Health Questionnaire-15, PHQ-15;the Work Productivity and Activity Impairment questionnaire, WPAI;Drug consumption;Adverse events;Radiating leg pain Numeric Rating Scale, NRS;Low back pain and radiating leg pain Visual Analogue Scale, VAS;Roland-Morris Disability Questionnaire-6, RMDQ-6;Patient Global Impression of Change, PGIC | — |
Countries
Korea, Republic of
Contacts
Public ContactJu Yeon Kim
Jaseng Medical Foundation
Outcome results
None listed