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

Jaseng Hospital of Korean Medicine

Status: Completed

Conditions: Radiculopathy Lumbar; Lumbar Disc Herniation

Treatments: Procedure: pharmacological treatment; Procedure: non-pharmacological treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05003726

JS-CT-2021-07

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 19 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups

Non-pharmacological group including KM

Experimental group

Description:

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.

Treatment:

Procedure: non-pharmacological treatment

Pharmacological group

Active Comparator group

Description:

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.

Treatment:

Procedure: pharmacological treatment