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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    30
  • sponsor
    Jaseng Hospital of Korean Medicine
Updated on 9 August 2021

Summary

This is a 2-arm parallel pragmatic randomized controlled trial that will compare non-pharmacological treatment with pharmacological therapy for lumbar disc herniation.

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. 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.

Details
Condition Lumbar Disc Prolapse With Radiculopathy
Treatment KM non-pharmacological treatment group, Pharmacological treatment group
Clinical Study IdentifierNCT04833270
SponsorJaseng Hospital of Korean Medicine
Last Modified on9 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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