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Clinical trial on Pharmacopuncture therapy for Lumbar Spinal Stenosis compared to Conventional Physical Therapy

Feasibility, Safety, and Effectiveness of Pharmacopuncture therapy for Degenerative Lumbar Spinal Stenosis compared to Conventional Physical Therapy: a pilot randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0010232
Enrollment
50
Registered
2025-02-25
Start date
2025-03-10
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

None listed

Interventions

Procedure/Surgery : 1. Experimental group
Pharmacopuncture therapy -Based on the clinical judgment of a Korean Medicine Doctor who considers the lesion of stenosis, symptom area, and tender point, the following sites and methods are selective
Conventional Physical Therapy (TENS
Microwave) - Transcutaneous Electrical Nerve Stimulation : Attach two pads on both sides of the lumbar spine considering the levels of spinal stenosis lesions. Apply low-frequency (20Hz) and high-inte

Sponsors

Pusan National University Korean Medicine Hospital
Lead Sponsor

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 with acupuncture hypersensitivity, metal allergies, severe atopic dermatitis, keloid skin, or other skin hypersensitivity 7) 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 8) Individuals taking medications (e.g., steroids, immunosuppressants) that may affect treatment outcomes or research results 9) Individuals with significant neuropsychiatric medical history or current illness 10) Individuals with a history of alcoholism or drug abuse 11) Pregnant or lactating women or those planning to become pregnant 12) Individuals who are unable to self-report consent/data or require assistance from a caregiver/researcher to do so 13) Other individuals deemed inappropriate by the clinical research coordinator

Design outcomes

Primary

MeasureTime frame
Feasibility

Secondary

MeasureTime frame
Safety assessment (Adverse effect);Visual analog scale (VAS);Zurich claudication questionaire (ZCQ) : ZCQ-symptom score, ZCQ-function score (Assessment for Symptom & Functional disability);Roland-Morris disability questionnaire (RMDQ) (Assessment for lumbar functional disability);Maxium walking distance;EuroQol-5D-5L (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+82-55-360-5690

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026