Clinical trial NCT05003726: Non-pharmacological Treatment and Pharmacological Treatment for Non-acute Lumbar Disc Herniation
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Disc Herniation
Radiculopathy Lumbar
Lead sponsor: Jaseng Hospital of Korean Medicine
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 36
Sex: ALL
Minimum age (years): 19
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Oswestry disability index (ODI)
timeFrame: week 1, 5, 9, 14, 27
Secondary outcomes:
measure: Numeric rating scale (NRS) of low back pain
timeFrame: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
measure: Visual analogue scale (VAS) of low back pain and radiating pain in lower extermities
timeFrame: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
measure: Numeric rating scale (NRS) of radiating pain in lower extremities
timeFrame: week -1, 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
measure: Patient global impression of change (PGIC)
timeFrame: week 9, 14, 27
measure: Short form-12 health survey version 2 (SF-12 v2)
timeFrame: week 1, 5, 9, 14, 27
measure: EuroQol-5 Dimension (EQ-5D-5L)
timeFrame: week 1, 5, 9, 14, 27
measure: Credibility and Expectancy
timeFrame: week -1
measure: Evaluation question
timeFrame: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
measure: Drug Consumption
timeFrame: week -1, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
measure: Adverse events
timeFrame: week -1, 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Bucheon Jaseng Hospital of Korean Medicine
state: Gyeonggi Province
city: Busan
country: Korea, Republic of
facility: Haeundae Jaseng Hospital of Korean Medicine
city: Daejeon
country: Korea, Republic of
facility: Daejeon Jaseng Hospital of Korean Medicine
city: Seoul
country: Korea, Republic of
facility: Jaseng Hospital of Korean Medicine
Study officials:
affiliation: Jaseng Hospital of Korean Medicine
name: Kyoung Sun Park, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: