Pragmatic Randomized Controlled Trial of Non-pharmacological Treatment for Lumbar Disc Herniation : A Pilot Study
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2021
CompletedFirst Posted
Study publicly available on registry
April 6, 2021
CompletedStudy Start
First participant enrolled
July 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2022
CompletedSeptember 27, 2022
September 1, 2022
12 months
April 4, 2021
September 26, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Numeric rating scale (NRS) of radiating pain in lower extremities
NRS is a pain scale in which the patient indicates their subjective pain as awhole number from 0 to 10, where 0 indicates 'no pain or discomfort' and10 indicates 'the most severe pain and discomfort imaginable'.
week 9
Secondary Outcomes (9)
Numeric rating scale (NRS) of radiating pain in lower extremities
week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
Numeric rating scale (NRS) of low-back pain
week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
Visual analogue scale (VAS) of leg radiating pain
week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
Visual analogue scale (VAS) of low-back pain
week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
Oswestry Disability Index (ODI)
week 1, 5, 9, 14, 27
- +4 more secondary outcomes
Study Arms (2)
KM non-pharmacological treatment group
EXPERIMENTALNon-pharmacological treatment including Korean medicine will be implemented to the participants twice a week for total 8 weeks. The specific intervention will be determined according to the physician's choice, and information will be recorded in the case report form.
Pharmacological treatment group
ACTIVE COMPARATORPharmacological treatment will be implemented to the participants twice a week for total 8 weeks. The specific intervention will be determined according to the physician's choice, and information will be recorded in the case report form.
Interventions
This is a pragmatic setting, and specific intervention is not determined prior to the study. Non-pharmacological treatment including Korean medicine, such as acupuncture, electroacupuncture and chuna, etc, will be chosen by professional physician according to the medical condition of each subject.
This is a pragmatic setting, and specific intervention is not determined prior to the study. The pharmacological treatment will be chosen by professional physician according to the medical condition of each subject.
Eligibility Criteria
You may qualify if:
- 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)
- years old
- participants who agreed and signed informed consent form
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jaseng Hospital of Korean Medicine
Seoul, 06110, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
Kyoung Sun Park, KMD,Ph.D
Jaseng Hospital of Korean Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief, Clinical study center
Study Record Dates
First Submitted
April 4, 2021
First Posted
April 6, 2021
Study Start
July 9, 2021
Primary Completion
June 28, 2022
Study Completion
June 28, 2022
Last Updated
September 27, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share