None listed
Conditions
Interventions
Medical Device : This study is a prospective, 2-arm, parallel, assessor-blind, randomized, and controlled trial. Participants assigned to the experimental group (acupuncture combined with usual care)
Sponsors
Pusan National University Korean Medicine Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women over 40 years of age 2. Patients who complain of discomfort in the back, buttocks, or lower limbs that started at least 3 months ago (numeric rating scale 4 or higher) 3. Patients with clinical features of lumbar spinal stenosis (LSS), such as neurogenic claudication or symptomatic changes according to position 4. Patients diagnosed with LSS by imaging studies using magnetic resonance imaging (MRI) or computed tomography (CT) within the last 2 years 5. Patients who listen to the research purpose and characteristics, and provide the written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with congenital stenosis, vertebral fractures, spinal infections or tumours, and other spinal diseases 2. Patients who underwent surgery for LSS or other spinal diseases, such as laminectomy, spinal fusion, or discectomy 3. Patients who underwent any other surgery that could affect the spine 4. Patients with compression fractures in the adjacent vertebrae at the level of LSS 5. Patients with severe osteoporosis 6. Patients with significant lumbar instability confirmed by imaging studies (anterior spondylolisthesis, posterior spondylolisthesis, degeneration of intervertebral disc, etc.) 7. Patients deemed unable to participate in the study due to severe complications (e.g., severe cardiopulmonary disease, severe diabetes mellitus, cognitive impairment, etc.) 8. Patients who initiated new medications or non-medication treatments, including oriental and western medical treatments, within the last month (not the exclusion criteria from 1 month ago) 9. Patients with diseases that require rapid surgical treatment, such as cauda equine syndrome 10. Patients who are uncooperative in the treatment process (e.g., those who have difficulties in meeting the visit schedule) 11. Patients judged by the researchers to be unsuitable for participation in the study (e.g., coagulation and bleeding disorders, severe depression, lack of cognitive ability, severe mental illness, focal skin infections, or skin trauma).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oswestry disability index | — |
Secondary
| Measure | Time frame |
|---|---|
| Self-reported pain-free walking distance;Medical expenses;Oswestry disability index;Back pain bothersomeness numeric rating scale (NRS);Back pain intensity NRS;Leg pain bothersomeness NRS;Leg pain intensity NRS;Quality of life;Patient satisfaction;Patient global assessment;Use of medications;Adverse events | — |
Countries
Korea, Republic of
Contacts
Public ContactYU KYUNG SHIN
Pusan National University Hospital
Outcome results
None listed