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

NCT05003726 | Completed DMC

• 1 other identifier: JS-CT-2021-07
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 4

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.

Conditions

Lumbar Disc Herniation; Radiculopathy Lumbar

Outcome Measures

Primary Outcomes (1)

• Oswestry disability index (ODI)

  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)

  week 1, 5, 9, 14, 27

Secondary Outcomes (10)

• 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 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

• Patient global impression of change (PGIC)

  week 9, 14, 27

• Short form-12 health survey version 2 (SF-12 v2)

  week 1, 5, 9, 14, 27

Study Arms (2)

Non-pharmacological group including KM

EXPERIMENTAL

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.

Procedure: non-pharmacological treatment

Pharmacological group

ACTIVE COMPARATOR

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.

Procedure: pharmacological treatment

Interventions

non-pharmacological treatment 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.

Non-pharmacological group including KM

pharmacological treatment 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.

Pharmacological group

Eligibility Criteria

• Age: 19 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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 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

Sponsors & Collaborators

• Jaseng Hospital of Korean Medicine: lead

Study Sites (4)

Bucheon Jaseng Hospital of Korean Medicine

Bucheon-si, Gyeonggi Province, 14598, South Korea

Location

Haeundae Jaseng Hospital of Korean Medicine

Busan, South Korea

Location

Daejeon Jaseng Hospital of Korean Medicine

Daejeon, South Korea

Location

Jaseng Hospital of Korean Medicine

Seoul, South Korea

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Kyoung Sun Park, Ph.D

  Jaseng Hospital of Korean Medicine

  PRINCIPAL INVESTIGATOR

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: August 11, 2021
• First Posted: August 12, 2021
• Study Start: October 15, 2021
• Primary Completion: January 4, 2023
• Study Completion: May 11, 2023
• Last Updated: May 30, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (4)