Ultrasound-guided Acupotomy Treatment for Degenerative Lumbar Spinal Stenosis

Feasibility, Safety, and Effectiveness of Ultrasound-guided Acupotomy Treatment for Degenerative Lumbar Spinal Stenosis: a pilot randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0009324

Enrollment

Registered

2024-04-09

Start date

2024-04-23

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device, Procedure/Surgery : 1. Ultrasound-guided Acupotomy therapy 2. Conventional Physical Therapy

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 (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

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 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

Design outcomes

Primary

Measure	Time frame
Feasibility	—

Secondary

Measure	Time frame
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)	—

Countries

Korea, Republic of

Contacts

Public ContactEunseok Kim

Pusan National University Korean Medicine Hospital

mybestcando@naver.com+82-55-360-5950

Outcome results