Status:
COMPLETED
Effectiveness and Safety of Pharmacopuncture Therapy for Patients with Lumbar Spinal Stenosis
Lead Sponsor:
Jaseng Medical Foundation
Conditions:
Lumbar Spinal Stenosis
Eligibility:
All Genders
19-69 years
Phase:
NA
Brief Summary
This is 1:1 pragmatic randomized controlled trials in a parallel-grouped, multi-centered design that investigated pharmacopuncture therapy for patients with lumbar spinal stenosis, compared to the con...
Detailed Description
This is 1:1 pragmatic randomized controlled trials in a parallel-grouped, multi-centered design that investigated pharmacopuncture therapy for patients with lumbar spinal stenosis, compared to the con...
Eligibility Criteria
Inclusion
- Diagnosed with lumbar spinal stenosis based on radiology including computed tomography or magnetic resonance imaging.
- Clear neurogenic claudication symptoms existed (symptoms aggravated with walking, and alleviated upon resting in lumbar flexion position).
- reported radiating leg pain or low back pain (LBP) with intensity of NRS ≥5
- Between the age of 19 and 69 years old.
- Participants who agreed to participate the study and voluntarily signed the informed consent form.
Exclusion
- Patients with vascular claudication
- Patients with pathologies of non-spinal origin that may cause LBP or radiating leg pain (e.g. spinal tumor, fracture)
- Patients with soft tissue pathologies that may cause LBP or radiating leg pain (e.g. tumor, fibromyalgia, rheumatoid arthritis, gout)
- Patients with other systemic diseases that may interfere with treatment effect or outcome interpretation
- Patients who administrate those prescribed medicine that may interfere with interpretation of the result (e.g. corticosteroids, immunosuppressants, physchotropic drugs)
- Patients for whom pharmacopuncture treatment may be inappropriate or unsafe (e.g. hemorrhagic diseases, blood clotting disorders, history of anti-coagulation medicine intake, serious diabetes with risk of infection)
- Patients who were treated with one of the following intervention within the past week; medicine that may potentially influence pain such as NSAIDs (nonsteroidal antiinflammatory drugs), pharmacopuncture, or physical therapies.
- Pregnant patients or patients planning pregnancy
- Patients with medical history of spinal surgery within the past 3 months
- Previous participation in other clinical studies within 1 month of current study enrollment, or plans to participate in other clinical studies during participation (including follow-up period) of the current study after study enrollment
- Patients unable to fill out study participation consent form
- Patients deemed unsuitable for study participation as assessed by the researchers
Key Trial Info
Start Date :
April 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2024
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT05242497
Start Date
April 13 2022
End Date
October 28 2024
Last Update
January 9 2025
Active Locations (7)
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1
Dongguk University Bundang Oriental Hospital
Seongnam-si, Bundang-gu, South Korea, 13601
2
Kyung Hee University Korean Medicine Hospital
Seoul, Dongdaemun-gu, South Korea, 130-701
3
Kyung Hee University Korean Medicine Hospital at Gangdong
Seoul, Gangdong-gu, South Korea, 05278
4
Jaseng Hospital of Korean Medicine
Seoul, Gangnam-Gu, South Korea, 135-896