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

Primary Purpose

Lumbar Disc Herniation, Radiculopathy Lumbar

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
non-pharmacological treatment
pharmacological treatment
Sponsored by
Jaseng Hospital of Korean Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Disc Herniation

Eligibility Criteria

19 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Bucheon Jaseng Hospital of Korean Medicine
  • Haeundae Jaseng Hospital of Korean Medicine
  • Daejeon Jaseng Hospital of Korean Medicine
  • Jaseng Hospital of Korean Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Non-pharmacological group including KM

Pharmacological group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Numeric rating scale (NRS) of low back pain
NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.
Visual analogue scale (VAS) of low back pain and radiating pain in lower extermities
Visual analogue scale of low back pain and radiating leg pain, minimum 0 to maximum 100,which is a higher score means a worse outcome.
Numeric rating scale (NRS) of radiating pain in lower extremities
NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.
Patient global impression of change (PGIC)
Participants rate the global impression of improvement after treatment on a 7-point Likert scale.
Short form-12 health survey version 2 (SF-12 v2)
The SF-12 consists of 12 questions across 8 domains, and higher scores indicate better health-related quality of life.
EuroQol-5 Dimension (EQ-5D-5L)
The EQ-5D-5L consists of 5 questions (mobility, self-care, usual activities, pain, anxiety/depression) that ask about the current state of health, and answers each question with 5 likert. (1=I have no problems about, 2=I have slight problems about, 3=I have moderate problems about, 4=I have severe problems about, 5=I am unable to about)
Credibility and Expectancy
To evaluate participants' expectations for treatment, the nine-point scale(Likert scale) is used to evaluate them. During the screening visit, the candidates will choose their scores in response to the question, "How much do you think non-drug therapy, including Korean medical treatment, or medication will relieve your symptoms?" (1 = not at all, 5 = somewhat, and 9 = very much)
Evaluation question
Use a questionnaire that measures official unofficial medical expenses, non-medical expenses, time costs, and productivity loss costs developed separately to measure cost items. Informal medical expenses, such as purchasing pars or medical devices, include transportation, patient time, transportation, patient time, and nursing costs are non-medical expenses. Productivity loss costs refer to the cost of economic loss caused by the disease itself or by the inability to participate in labor due to premature death from the disease. To calculate the cost of productivity loss, we will use the Work Productivity and Activity Impairment questionnair (WPAI) to convert it into cost-effectiveness analysis.
Drug Consumption
The type and dose of prescribed drugs or relief drugs due to the active history of drugs taken during the study period are observed through a questionnaire when visiting the study subjects. Other than the medication you are taking, physical therapy, injection therapy, etc. should be recorded in the number of times.
Adverse events
Safety will be verified by comparing the occurrence of adverse events between the two groups. The researcher evaluates each treatment method and its adverse events on a six-step scale according to the WHO-UMC UMC causality assessment system (1=definitive linked, 2=provocatively linked, 4=probably not related, 5=definitive not related, 5=definitive not related to the study), and all adverse events are classified into three stages by the Spilker taxonomy (Mild(1)): If treatment is not required and does not significantly impair the normal life function, Moderate(2): may significantly impair normal life function, and may require treatment, and Severe(3): severe adverse events require high treatment, and side effects remain.

Full Information

First Posted
August 11, 2021
Last Updated
May 25, 2023
Sponsor
Jaseng Hospital of Korean Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05003726
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
October 15, 2021 (Actual)
Primary Completion Date
January 4, 2023 (Actual)
Study Completion Date
May 11, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jaseng Hospital of Korean Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation, Radiculopathy Lumbar

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-pharmacological group including KM
Arm Type
Experimental
Arm 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.
Arm Title
Pharmacological group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
non-pharmacological treatment
Intervention Description
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
Procedure
Intervention Name(s)
pharmacological treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Oswestry disability index (ODI)
Description
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)
Time Frame
week 1, 5, 9, 14, 27
Secondary Outcome Measure Information:
Title
Numeric rating scale (NRS) of low back pain
Description
NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.
Time Frame
week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
Title
Visual analogue scale (VAS) of low back pain and radiating pain in lower extermities
Description
Visual analogue scale of low back pain and radiating leg pain, minimum 0 to maximum 100,which is a higher score means a worse outcome.
Time Frame
week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
Title
Numeric rating scale (NRS) of radiating pain in lower extremities
Description
NRS is a pain scale in which the patient indicates their subjective pain as a whole number from 0 to 10, where 0 indicates 'no pain or discomfort' and 10 indicates 'the most severe pain and discomfort imaginable'.
Time Frame
week -1, 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
Title
Patient global impression of change (PGIC)
Description
Participants rate the global impression of improvement after treatment on a 7-point Likert scale.
Time Frame
week 9, 14, 27
Title
Short form-12 health survey version 2 (SF-12 v2)
Description
The SF-12 consists of 12 questions across 8 domains, and higher scores indicate better health-related quality of life.
Time Frame
week 1, 5, 9, 14, 27
Title
EuroQol-5 Dimension (EQ-5D-5L)
Description
The EQ-5D-5L consists of 5 questions (mobility, self-care, usual activities, pain, anxiety/depression) that ask about the current state of health, and answers each question with 5 likert. (1=I have no problems about, 2=I have slight problems about, 3=I have moderate problems about, 4=I have severe problems about, 5=I am unable to about)
Time Frame
week 1, 5, 9, 14, 27
Title
Credibility and Expectancy
Description
To evaluate participants' expectations for treatment, the nine-point scale(Likert scale) is used to evaluate them. During the screening visit, the candidates will choose their scores in response to the question, "How much do you think non-drug therapy, including Korean medical treatment, or medication will relieve your symptoms?" (1 = not at all, 5 = somewhat, and 9 = very much)
Time Frame
week -1
Title
Evaluation question
Description
Use a questionnaire that measures official unofficial medical expenses, non-medical expenses, time costs, and productivity loss costs developed separately to measure cost items. Informal medical expenses, such as purchasing pars or medical devices, include transportation, patient time, transportation, patient time, and nursing costs are non-medical expenses. Productivity loss costs refer to the cost of economic loss caused by the disease itself or by the inability to participate in labor due to premature death from the disease. To calculate the cost of productivity loss, we will use the Work Productivity and Activity Impairment questionnair (WPAI) to convert it into cost-effectiveness analysis.
Time Frame
week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
Title
Drug Consumption
Description
The type and dose of prescribed drugs or relief drugs due to the active history of drugs taken during the study period are observed through a questionnaire when visiting the study subjects. Other than the medication you are taking, physical therapy, injection therapy, etc. should be recorded in the number of times.
Time Frame
week -1, 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
Title
Adverse events
Description
Safety will be verified by comparing the occurrence of adverse events between the two groups. The researcher evaluates each treatment method and its adverse events on a six-step scale according to the WHO-UMC UMC causality assessment system (1=definitive linked, 2=provocatively linked, 4=probably not related, 5=definitive not related, 5=definitive not related to the study), and all adverse events are classified into three stages by the Spilker taxonomy (Mild(1)): If treatment is not required and does not significantly impair the normal life function, Moderate(2): may significantly impair normal life function, and may require treatment, and Severe(3): severe adverse events require high treatment, and side effects remain.
Time Frame
week -1, 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 19-69 years old participants who agreed and signed informed consent form Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyoung Sun Park, Ph.D
Organizational Affiliation
Jaseng Hospital of Korean Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bucheon Jaseng Hospital of Korean Medicine
City
Bucheon
State/Province
Gyeonggi Province
ZIP/Postal Code
14598
Country
Korea, Republic of
Facility Name
Haeundae Jaseng Hospital of Korean Medicine
City
Busan
Country
Korea, Republic of
Facility Name
Daejeon Jaseng Hospital of Korean Medicine
City
Daejeon
Country
Korea, Republic of
Facility Name
Jaseng Hospital of Korean Medicine
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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