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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0007229
Enrollment
40
Registered
2022-04-26
Start date
2022-04-18
Completion date
Unknown
Last updated
2022-05-02

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

Conditions

None listed

Interventions

Others(pharmacopuncture therapy, acupuncture, electroacupuncture, cupping, infrared irradiation) : 1. pharmacopuncture therapy - Specific pharmacopuncture intervention will be chosen by a clinical exp

Sponsors

Korea Institute of Oriental Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Diagnosed with lumbar spinal stenosis by CT or MRI. - If there is no existing image data or if re-examination is necessary, L-spine CT scan will be performed 2. Pain or discomfort in the lower extremities/buttocks = VAS 40mm 3. Those who have clinical features of spinal stenosis, such as neurogenic claudication or changes in symptoms due to position 4. Those who are finally diagnosed with lumbar spinal stenosis as a result of a comprehensive physical examination, medical history examination, and imaging examination 5. Those who voluntarily decide to participate after hearing the explanation of the research purpose and process and consent in writing

Exclusion criteria

Exclusion criteria: 1. Those who are diagnosed with congenital or developmental spinal stenosis 2. Those who have serious defects due to spinal canal problems such as spinal segment muscle atrophy, gait disorder, and Cauda equina syndrome 3. Those who are moderate to severe spinal malalignment and spinal instability due to spondylolisthesis, spondylolysis, thoracic and lumbar fractures, etc. 4. Those who are diagnosed with other spinal diseases such as vertebral body tumors, spinal infections, ankylosing spondylosis, etc. 5. History of spinal surgery such as spinal fusion or laminectomy 6. Those who have factors that may affect hemostasis, such as taking anticoagulants and antiplatelet drugs, and bleeding disorders 7. History of acupuncture hypersensitivity, metal allergy, severe atopic dermatitis, keloid skin, and other skin hypersensitivity 8. Those with moderate to severe chronic kidney disease (Chronic Kidney Disease stage = 4), uncontrolled diabetes mellitus, or severe cardiovascular disease 9. Those who have a significant neuropsychiatric history or who are currently mentally or cognitively unstable 10. History of alcoholism or drug abuse 11. Those who have a serious underlying disease who is receiving active treatment for it 12. Pregnant woman, lactating woman, or woman in childbearing years who plans on being pregnant 13. Those who can not write informed consent/data by themselves or under the supervision of a guardian/researcher 14. Those who are difficult to participate in the trial according to investigator's decision

Design outcomes

Primary

MeasureTime frame
Visual analog scale(VAS)

Secondary

MeasureTime frame
Zurich claudication questionaire (ZCQ);Maximum walking distance;Modified-Modified Schober Test(MMST) ;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 6, 2026