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Add-on effect and safety of pharmacopuncture therapy and acupotomy in the treatment of patients with lumbar spinal stenosis

Add-on effect and safety of pharmacopuncture therapy and acupotomy in the treatment of patients with lumbar spinal stenosis : a pragmatic assessor-blinded, randomized, controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0008557
Enrollment
104
Registered
2023-06-26
Start date
2023-03-07
Completion date
Unknown
Last updated
2023-09-18

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

Conditions

None listed

Interventions

Others : 1. Pharmcopuncture therapy - Based on clinical judgment considering the location of the lesion on imaging, radiation pain area, pain site, and tenderness, selectively combine the following ar

Sponsors

Korea Institute of Oriental Medicine
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 structural problems in the spine that may cause lower back pain and radiating pain (e.g., acute thoracolumbar fractures, spinal dislocation, spondylolisthesis) 4) Individuals with a history of spinal surgery, such as spinal fusion or laminectomy 5) Individuals taking anticoagulants or antiplatelet drugs, or with bleeding disorders that may affect hemostasis 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
Visual analog scale(VAS)

Secondary

MeasureTime frame
Zurich claudication questionaire (ZCQ) : ZCQ-symptom score, ZCQ-function score;Roland-Morris disability questionnaire (RMDQ);Maxium walking distance;EuroQol-5D-5L index(EQ-5D-5L) ;Patient Global Impression of change (PGIC) ;Clinically important difference (CID);Safety assessment(Adverse effect)

Countries

Korea, Republic of

Contacts

Public ContactEunseok Kim

Pusan National University Korean Medicine Hospital

mybestcando@naver.com+82-55-360-5967

Outcome results

None listed

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