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

Not Applicable

Recruiting

• Conditions: Diseases of the musculoskeletal system and connective tissue

• Registration Number: KCT0008557
• Lead Sponsor: Korea Institute of Oriental Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 104

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

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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual analog scale(VAS)

Secondary Outcome Measures

Name	Time	Method
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)