Clinical trial NCT04833270: Pragmatic Randomized Controlled Trial of Non-pharmacological Treatment for Lumbar Disc Herniation : A Pilot Study
Official title: Pragmatic Randomized Controlled Trial of Non-pharmacological Treatment for Lumbar Disc Herniation : A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Disc Prolapse With Radiculopathy
Lead sponsor: Jaseng Hospital of Korean Medicine
Sponsor class: OTHER
Collaborators: name: Korea Institute of Oriental Medicine
First posted: 2021-04-06
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Numeric rating scale (NRS) of radiating pain in lower extremities
timeFrame: week 9
Secondary outcomes:
measure: Numeric rating scale (NRS) of radiating pain in lower extremities
timeFrame: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
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 leg radiating pain
timeFrame: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
measure: Visual analogue scale (VAS) of low-back pain
timeFrame: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
measure: Oswestry Disability Index (ODI)
timeFrame: week 1, 5, 9, 14, 27
measure: Fear-Avoidance Beliefs Questionnaire (FABQ)
timeFrame: week 1, 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
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jaseng Hospital of Korean Medicine
Study officials:
affiliation: Jaseng Hospital of Korean Medicine
name: Kyoung Sun Park, KMD,Ph.D
role: PRINCIPAL_INVESTIGATOR
References: