Status:
COMPLETED
Pragmatic Randomized Controlled Trial of Non-pharmacological Treatment for Lumbar Disc Herniation : A Pilot Study
Lead Sponsor:
Jaseng Hospital of Korean Medicine
Collaborating Sponsors:
Korea Institute of Oriental Medicine
Conditions:
Lumbar Disc Prolapse With Radiculopathy
Eligibility:
All Genders
19-70 years
Phase:
NA
Brief Summary
This is a 2-arm parallel pragmatic randomized controlled trial that will compare non-pharmacological treatment with pharmacological therapy for lumbar disc herniation.
Detailed Description
Participants who voluntarily signed informed consent form and eligible for the study were randomly assigned in a 1:1 ratio (15:15) for non-pharmacological treatment and pharmacological treatment group...
Eligibility Criteria
Inclusion
- Numeric rating scale (NRS) score of radiating pain 5 or more for recent 3 serial days.
- Onset time of radiating pain occurred within 12 weeks.
- Radiologically diagnosed with lumbar disc herniation in lumbar spine magnetic resonance imaging (L-spine MRI)
- 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, orpsychotropic medications or any other medication that can interrupt the study result
- 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 :
July 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04833270
Start Date
July 9 2021
End Date
June 28 2022
Last Update
September 27 2022
Active Locations (1)
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1
Jaseng Hospital of Korean Medicine
Seoul, South Korea, 06110