ltrasound-guided Acupotomy Treatment for Degenerative Lumbar Spinal Stenosis
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- KCT0009324
- Lead Sponsor
- Pusan National University Korean Medicine Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 50
1) aged 40 years and older but younger than 75 years
2) confirmed to have lumbar spinal stenosis on imaging examination (CT or MRI)
- In cases where there is no existing imaging data or re-imaging is necessary, L-spine CT 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 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
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
4) Individuals with major structural issues of the spine (acute thoracolumbar vertebral fracture, spinal dislocation, spondylolisthesis)
5) Individuals with a history of spinal surgery, such as spinal fusion or laminectomy
6) Individuals taking anticoagulants or antiplatelet drugs, or with bleeding disorders that may affect hemostasis
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 alcoholism or drug abuse
12) Pregnant or lactating women or those planning to become pregnant
13) Individuals who are unable to self-report consent/data or require assistance from a caregiver/researcher to do so
14) Other individuals deemed inappropriate by the clinical research coordinator
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Feasibility
- Secondary Outcome Measures
Name Time Method Safety assessment (Adverse effect);Visual analog scale (VAS);Zurich claudication questionaire (ZCQ) : ZCQ-symptom score, ZCQ-function score;Oswestry Disability Index (ODI);Maxium walking distance;EuroQol-5D-5L index(EQ-5D-5L) ;Patient Global Impression of change (PGIC)