None listed
Conditions
Interventions
Others(Combined Treatment of Acupuncture and Pharmacopuncture Therapy) : Combined treatment of pharmacopuncture and acupuncture, or standard medical treatment, is administered twice a week for a total
Sponsors
Kyung Hee University Oriental Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female aged 19 to under 65 years. 2. Low back pain persisting for more than 3 months, with low back pain as the primary complaint. 3. Pain and bothersomeness scored 4 or higher on a 10 cm Visual Analogue Scale (VAS) within the week prior to the study. 4. Voluntary participation after receiving a detailed explanation of the clinical trial and providing written informed consent to adhere to the precautions.
Exclusion criteria
Exclusion criteria: 1. Radiating pain in areas other than the lumbar region or symptoms extending to the lower extremities. 2. Abnormalities observed during neurological examinations of the lower extremities. 3. Severe neurological symptoms, such as cauda equina syndrome or pronounced sensory or motor paralysis, requiring surgical intervention. 4. History of spinal surgery or scheduled surgery during the clinical trial period. 5. Diagnosis of neuromuscular scoliosis or neurodegenerative diseases. 6. Low back pain potentially attributable to specific medical conditions, such as vertebral fractures, inflammatory spondylitis, spinal infections, or malignancies. 7. Presence of pain more severe in regions other than the lumbar area. 8. Unsuitability or safety concerns regarding herbal acupuncture treatment, including individuals with bleeding disorders, those receiving anticoagulant therapy, or those with severe diabetes prone to infections. 9. Recent use (within the past two weeks) of medications that could affect pain, such as Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), or recent experience with acupuncture, herbal acupuncture, or physical therapy. 10. Pregnant or lactating women, those planning pregnancy, or individuals of childbearing potential not using appropriate contraceptive measures. 11. Participation in another clinical trial related to chronic low back pain within the past month. 12. Any other conditions deemed inappropriate for inclusion by the clinical investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in pain score (VAS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in pain score (VAS);Proportion of trial participants whose VAS pain score decreased by at least the MCID (Minimal Clinically Important Difference; VAS 2) ;Proportion of trial participants whose VAS pain score decreased by at least 30%;Proportion of trial participants whose VAS pain score decreased by at least 50%;Change in Roland and Morris Disability Questionnaire (RMDQ);Change in EuroQol-5D (EQ-5D) score;Patient Global Impression of Change (PGIC) | — |
Countries
Korea, Republic of
Contacts
Public ContactYejin Hong
Kyung Hee University Hospital
Outcome results
None listed