None listed
Conditions
Interventions
Procedure/Surgery : Participants in the experimental group will receive thread-embedding acupuncture (TEA) once weekly for 4 weeks (total of 4 sessions).
The treatment points will include the EX-B2 po
Sponsors
Pusan National University Korean Medicine Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adults aged 40 to 74 years. 2) Diagnosis of lumbar spinal stenosis confirmed by imaging (CT or MRI). 3) Low back and/or buttock or leg pain or discomfort with a visual analogue scale (VAS) score = 40 mm. 4) Presence of clinical symptoms consistent with lumbar spinal stenosis, such as neurogenic claudication or postural symptom changes. 5) Final diagnosis of degenerative lumbar spinal stenosis based on comprehensive evaluation of medical history, physical examination, and imaging studies. 6) Individuals who voluntarily agree to participate after receiving an explanation of the study purpose and procedures, and who provide written informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients diagnosed with congenital or developmental lumbar spinal stenosis. 2) Patients with other spinal diseases that may cause low back pain or radiating pain 3) Patients with arterial stenosis or occlusion of the lower extremities that may cause intermittent claudication. 4) Patients with structural spinal abnormalities 5) History of spinal surgery, including spinal fusion or laminectomy. 6) Patients with bleeding tendencies or coagulation disorders that make thread-embedding acupuncture inappropriate. 7) Patients with a previous history of thread-embedding acupuncture for lumbar spinal stenosis. 8) Patients with hypersensitivity to acupuncture, metal allergy, severe atopic dermatitis, keloid formation, or other significant skin hypersensitivity conditions. 9) Patients with serious cardiovascular, hypertensive, diabetic, renal, hepatic, or cerebrovascular diseases that could affect treatment outcomes. 10) Patients currently taking medications that may influence study results 11) Patients with a history or current diagnosis of significant neuropsychiatric disorders. 12) Patients with a history of alcohol or drug abuse. 13) Patients receiving active treatment for any severe underlying medical condition. 14) Pregnant or lactating women, or women planning to become pregnant during the study period. 15) Patients who are unable to complete patient-reported outcome measures, even with assistance from a caregiver or researcher. 16) Any individual deemed inappropriate for participation by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility (Recruitment rate, Completion rate, Protocol adherence, Acceptability, Study duration, Blinding maintenance) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Evaluation;Mean change in the Visual Analogue Scale (VAS) score for low back and buttock/leg pain or discomfort;Mean change in the Zurich claudication questionaire (ZCQ) function/symptom score;Mean change in the Roland-Morris Disability Questionnaire (RMDQ) ;Mean change in self-reported walking distance;EuroQol-5D-5L (EQ-5D-5L) index;Patient Global Impression of change (PGIC) | — |
Countries
Korea, Republic of
Contacts
Public ContactYoona Oh
Pusan National University Korean Medicine Hospital
Outcome results
None listed