Non-pharmacological Treatment and Pharmacological Treatment for Non-acute Lumbar Disc Herniation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-15

Study Completion Date

2023-05-11

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lumbar Disc Herniation Radiculopathy Lumbar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Non-pharmacological group including KM

Non-pharmacological treatment including Korean medicine will be implemented to the participants for total 8 weeks. This is a pragmatic clinical trial, and the specific intervention will be determined according to the physician's choice. intervention data will be recorded in the case report form.

Group Type EXPERIMENTAL

non-pharmacological treatment

Intervention Type PROCEDURE

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.

Pharmacological group

Pharmacological treatment will be implemented to the participants for total 8 weeks. This is a pragmatic clinical trial, and the specific intervention will be determined according to the physician's choice. intervention data will be recorded in the case report form.

Group Type ACTIVE_COMPARATOR

pharmacological treatment

Intervention Type PROCEDURE

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.

Interventions

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non-pharmacological treatment

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.

Intervention Type PROCEDURE

pharmacological treatment

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Numeric rating scale (NRS) score of radiating pain or low back pain 5 or more for recent 3 serial days.
2. Onset time of radiating pain occurred 3 months before enrollment.
3. 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
4. 19-69 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 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

Minimum Eligible Age

19 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No