None listed
Conditions
Interventions
Medical Device, Procedure/Surgery : 1. Ultrasound-guided Acupotomy therapy
2. Conventional Physical Therapy (TENS
Microwave)
Intervention phase : Each group will receive the assigned treatment twice a week for 4 weeks.
Follow-up phase : Assessments will be performed at Week 5 (1 week post-treatment), Week 8 (4 w
Sponsors
Pusan National University Korean Medicine Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) aged 40 years and older but younger than 75 years 2) confirmed to have lumbar spinal stenosis on imaging examination (L-spine MRI) - In cases where there is no existing imaging data or re-imaging is necessary, L-spine MRI examination will be performed 3) pain or discomfort in the lumbar, lower limb, or buttock = VAS 40mm 4) Individuals who have clinical manifestations of lumbar spinal stenosis, such as neurogenic claudication or symptoms that change with posture 5) Individuals who have received a final diagnosis of degenerative lumbar spinal stenosis based on comprehensive physical examination, medical history, and imaging examination results 6) Individuals who voluntarily decide to participate after being informed of the study purpose and procedure and provide written informed consent
Exclusion criteria
Exclusion criteria: 1) Individuals diagnosed with congenital or developmental lumbar spinal stenosis 2) Individuals diagnosed with spinal disorders other than lumbar spinal stenosis, which may cause lower back pain and radiating pain (e.g., vertebral tumors, Cauda equina syndrome, spinal infections, ankylosing spondylitis) 3) Individuals with lower extremity arterial stenosis or occlusion that can induce claudication (in cases where ABI 1.4) 4) Individuals with major structural issues of the spine (acute thoracolumbar vertebral fracture, spinal dislocation, spondylolysis) 5) Individuals with a history of spinal surgery, such as spinal fusion or laminectomy 6) Individuals deemed unsuitable for the acupotomy procedure due to abnormal hemostasis, such as those taking anticoagulants or antiplatelet drugs, or those with bleeding disorders 7) Individuals with acupuncture hypersensitivity, metal allergies, severe atopic dermatitis, keloid skin, or other skin hypersensitivity 8) Individuals with chronic diseases (e.g., chronic kidney disease, diabetic neuropathy, stroke and myocardial infarction, dementia, epilepsy) that may affect treatment outcomes or research results 9) Individuals taking medications (e.g., steroids, immunosuppressants) that may affect treatment outcomes or research results 10) Individuals with significant neuropsychiatric medical history or current illness 11) Individuals with a history of alcohol or drug abuse 12) Pregnant or lactating women or those planning to become pregnant 13) Individuals who are unable to complete patient-reported outcome measures, even with assistance from a caregiver or researcher 14) Other individuals deemed inappropriate by the clinical research coordinator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual analog scale (VAS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Zurich claudication questionaire (ZCQ) : ZCQ-symptom score, ZCQ-function score;Oswestry Disability Index (ODI);Maxium walking distance;EuroQol-5D-5L index(EQ-5D-5L) ;Elastic modulus of the multifidus muscle;Patient Global Impression of change (PGIC);Clinically important difference (CID);Use of rescue medication;Safety assessment (Adverse effect);Economic Evaluation | — |
Countries
Korea, Republic of
Contacts
Public ContactEunseok Kim
Pusan National University Korean Medicine Hospital
Outcome results
None listed