Pragmatic Randomized Controlled Trial of Non-pharmacological Treatment for Lumbar Disc Herniation : A Pilot Study

Launched by JASENG HOSPITAL OF KOREAN MEDICINE · Apr 4, 2021

Keywords

ClinConnect Summary

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. Participants of each group will receive twice a week for total 8 weeks of intervention. This is a pragmatic randomized controlled trial, so physicians will have medical decision making according to each participant's conditions and choose the specific intervention and dosage of pharmacological and non-pharmacological treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Numeric rating scale (NRS) score of radiating pain 5 or more for recent 3 serial days.
• • 2. Onset time of radiating pain occurred within 12 weeks.
• • 3. Radiologically diagnosed with lumbar disc herniation in lumbar spine magnetic resonance imaging (L-spine MRI)
• • 4. 19-70 years old
• • 5. participants who agreed and signed informed consent form
• Exclusion Criteria:
• • 1. Spine metastasis of cancer, acute fracture of spine, or spine dislocation
• • 2. Progressive neurologic deficits or severe neurologic deficits
• • 3. Soft tissue diseases that can induce low back pain(ie. cancer, fibromyalgia, rheumatoid arthritis, gout,etc)
• • 4. Presence of chronic underlying disease which can interfere the efficacy or interpretation (ie. stroke, myocardial infarct, kidney disease, dementia, diabetic neuropathy, epilepsy, etc)
• • 5. Concurrent use of steroids, immunosuppressants, orpsychotropic medications or any other medication that can interrupt the study result
• • 6. Hemorrhagic disease, severe diabetes or taking anticoagulant drug
• • 7. Participants who took NSAIDs or pharmacopuncture within 1 week
• • 8. Pregnant or lactating women
• • 9. Participants who had undergone lumbar surgery within 3 months
• • 10. 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
• • 11. Participants who can not write informed consent
• • 12. Participants who is difficult to participate in the trial according to investigator's decision