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

NCT ID: NCT04833270

Last Updated: 2022-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-09
• Study Completion Date: 2022-06-28

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.

Detailed 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.

Conditions

Lumbar Disc Prolapse With Radiculopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

KM non-pharmacological treatment group

Non-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.

Group Type: EXPERIMENTAL

KM non-pharmacological treatment group

Intervention Type: OTHER

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 treatment group

Pharmacological 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.

Group Type: ACTIVE_COMPARATOR

Pharmacological treatment group

Intervention Type: OTHER

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

KM non-pharmacological treatment group

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: OTHER

Pharmacological treatment group

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: OTHER

Eligibility Criteria

Inclusion Criteria

1. Numeric rating scale (NRS) score of radiating pain 5 or more for recent 3 serial days.

2. Onset time of radiating pain occurred within 12 weeks.

3. Radiologically diagnosed with lumbar disc herniation in lumbar spine magnetic resonance imaging (L-spine MRI)

4. 19-70 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 or pharmacopuncture 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: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korea Institute of Oriental Medicine

OTHER_GOV

Sponsor Role: collaborator

Jaseng Hospital of Korean Medicine

OTHER

Sponsor Role: lead

Responsible Party

Kyoung Sun Park

Chief, Clinical study center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kyoung Sun Park, KMD,Ph.D

Role: PRINCIPAL_INVESTIGATOR

Jaseng Hospital of Korean Medicine

Locations

Jaseng Hospital of Korean Medicine

Seoul, , South Korea

Countries

South Korea

Other Identifiers

JS-CT-2021-01

Identifier Type: -

Identifier Source: org_study_id