Comparative Effectiveness of Non-pharmacological Treatment and Pharmacological Treatment for Non-acute Lumbar Disc Herniation : a Multi-centered, Pragmatic Randomized Controlled, Parallel-grouped Pilot Study

Jaseng Hospital of Korean Medicine4 sites in 1 country36 target enrollmentOctober 15, 2021

ConditionsLumbar Disc Herniation Radiculopathy Lumbar

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Lumbar Disc Herniation
Sponsor: Jaseng Hospital of Korean Medicine
Enrollment: 36
Locations: 4
Primary Endpoint: Oswestry disability index (ODI)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a 2-armed parallel, multi-centered, pragmatic clinical trial that compares the comparative effectiveness of non-pharmacological treatment and pharmacological treatment for non-acute lumbar disc herniation.

Detailed Description

This study is a multi-centered, pragmatic clinical trial that compares the comparative effectiveness of non-pharmacological treatment and pharmacological treatment for non-acute lumbar disc herniation. The participants who voluntarily signed informed consent will be randomly assigned in 1:2 ratio to non-pharmacological group and pharmacological group and will receive the 8 weeks of intervention.

Registry

clinicaltrials.gov

Start Date

October 15, 2021

End Date

May 11, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Jaseng Hospital of Korean Medicine

Responsible Party

Principal Investigator

Kyoung Sun Park

Chief, clinical study center

Jaseng Hospital of Korean Medicine

Eligibility Criteria

Inclusion Criteria

•Numeric rating scale (NRS) score of radiating pain or low back pain 5 or more for recent 3 serial days.
•Onset time of radiating pain occurred 3 months before enrollment.
•Radiologically diagnosed with lumbar disc herniation in lumbar spine magnetic resonance imaging (L-spine MRI), which can explain lower extremity radiation pain and back pain
•19-69 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 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

Outcomes

Primary Outcomes

Oswestry disability index (ODI)

Time Frame: week 1, 5, 9, 14, 27

ODI is a functional disability questionnaire. The possible range of eachitem score is 0 to 5. Total score range is 0 (better outcome) to 100 (worse outcome)

Secondary Outcomes

Visual analogue scale (VAS) of low back pain and radiating pain in lower extermities(week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27)
Numeric rating scale (NRS) of radiating pain in lower extremities(week -1, 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27)
Short form-12 health survey version 2 (SF-12 v2)(week 1, 5, 9, 14, 27)
Evaluation question(week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27)
Drug Consumption(week -1, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27)
Adverse events(week -1, 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)
EuroQol-5 Dimension (EQ-5D-5L)(week 1, 5, 9, 14, 27)
Credibility and Expectancy(week -1)
Patient global impression of change (PGIC)(week 9, 14, 27)