Status:
COMPLETED
Effectiveness and Safety of Pharmacopunture Therapy for Chronic Low Back Pain: A Pragmatic Randomized Controlled Trial
Lead Sponsor:
Jaseng Medical Foundation
Collaborating Sponsors:
Korea Institute of Oriental Medicine
Conditions:
Chronic Low-back Pain
Eligibility:
All Genders
19-70 years
Phase:
NA
Brief Summary
This is a multi-center, 2-arm parallel pragmatic randomized controlled trial that will compare pharmacopuncture therapy with physical therapy for chronic low back pain.
Detailed Description
This is a multi-center, 2-arm parallel pragmatic randomized controlled trial that will compare pharmacopuncture therapy with physical therapy for chronic low back pain. Participants who voluntarily si...
Eligibility Criteria
Inclusion
- low back pain for more than 6 months
- Numeric rating scale (NRS) score for low back pain 5 or more
- 19-70 years old
- participants who agreed and signed informed consent form
Exclusion
- Spine metastasis of cancer, acute fracture of spine, or spine dislocation
- Progressive neurologic deficits or severe neurologic deficits
- Soft tissue diseases that can induce low back pain (ie. cancer, fibromyalgia, rheumatoid arthritis, gout, etc)
- Presence of chronic underlying disease which can interfere the efficacy or interpretation (ie. stroke, myocardial infarct, kidney disease, dementia, diabetic neuropathy, epilepsy, etc)
- Concurrent use of steroids, immunosuppressants, or psychotropic medications
- Hemorrhagic disease, severe diabetes or taking anticoagulant drug
- Participants who took NSAIDs or pharmacopuncture within 1 week
- Pregnant or lactating women
- Participants who had undergone lumbar surgery within 3 months
- Participants who had participated in other clinical trial within 1 month, or have plan for participation in other trial during follow up period of this trial
- Participants who can not write informed consent
- Participants who is difficult to participate in the trial according to investigator's decision
Key Trial Info
Start Date :
June 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 26 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04833309
Start Date
June 10 2021
End Date
February 26 2022
Last Update
December 18 2024
Active Locations (4)
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1
Jaseng Hospital of Korean Medicine
Seoul, Gangnam-Gu, South Korea, 135-896
2
Bucheon Jaseng Hospital of Korean Medicine
Bucheon-si, Gyeonggi Province, South Korea, 14598
3
Haeundae Jaseng Hospital of Korean Medicine
Busan, South Korea, 48102
4
Daejeon Jaseng Hospital of Korean Medicine
Daejeon, South Korea, 35262