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

Primary Purpose

Lumbar Disc Prolapse With Radiculopathy

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
KM non-pharmacological treatment group
Pharmacological treatment group
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 Prolapse With Radiculopathy

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jaseng Hospital of Korean Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

KM non-pharmacological treatment group

Pharmacological treatment group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Numeric rating scale (NRS) of radiating pain in lower extremities
NRS is a pain scale in which the patient indicates their subjective pain as awhole number from 0 to 10, where 0 indicates 'no pain or discomfort' and10 indicates 'the most severe pain and discomfort imaginable'.

Secondary Outcome Measures

Numeric rating scale (NRS) of radiating pain in lower extremities
NRS is a pain scale in which the patient indicates their subjective pain as awhole number from 0 to 10, where 0 indicates 'no pain or discomfort' and10 indicates 'the most severe pain and discomfort imaginable'.
Numeric rating scale (NRS) of low-back pain
NRS is a pain scale in which the patient indicates their subjective pain as awhole number from 0 to 10, where 0 indicates 'no pain or discomfort' and10 indicates 'the most severe pain and discomfort imaginable'.
Visual analogue scale (VAS) of leg radiating pain
Visual analogue scale of radiating leg pain, minimum 0 to maximum 100,which is a higher score means a worse outcome.
Visual analogue scale (VAS) of low-back pain
Visual analogue scale of radiating leg pain, minimum 0 to maximum 100,which is a higher score means a worse outcome.
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)
Fear-Avoidance Beliefs Questionnaire (FABQ)
FABQ is one of pateint-reported outcome questionnaire which consists of total 16 questions. Through FABQ, the investigator can evaluate fear avoidance responses, especially in physical and occupational activity domain for patients with low-back pain
Patient Global Impression of Change (PGIC)
Participants rate the improvement after treatment on a 7-point Likert scale(1, very much improved; 2, much improved; 3, minimally improved; 4, nochange; 5, minimally worse; 6, much worse; or 7, very much worse.)
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)

Full Information

First Posted
April 4, 2021
Last Updated
September 26, 2022
Sponsor
Jaseng Hospital of Korean Medicine
Collaborators
Korea Institute of Oriental Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04833270
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
July 9, 2021 (Actual)
Primary Completion Date
June 28, 2022 (Actual)
Study Completion Date
June 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jaseng Hospital of Korean Medicine
Collaborators
Korea Institute of Oriental 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 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.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
KM non-pharmacological treatment group
Arm Type
Experimental
Arm Description
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.
Arm Title
Pharmacological treatment group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
KM non-pharmacological treatment group
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
Other
Intervention Name(s)
Pharmacological treatment group
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
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 awhole number from 0 to 10, where 0 indicates 'no pain or discomfort' and10 indicates 'the most severe pain and discomfort imaginable'.
Time Frame
week 9
Secondary Outcome Measure Information:
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 awhole number from 0 to 10, where 0 indicates 'no pain or discomfort' and10 indicates 'the most severe pain and discomfort imaginable'.
Time Frame
week 1, 2, 3, 4, 5, 6, 7, 8, 9, 14, 27
Title
Numeric rating scale (NRS) of low-back pain
Description
NRS is a pain scale in which the patient indicates their subjective pain as awhole number from 0 to 10, where 0 indicates 'no pain or discomfort' and10 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 leg radiating pain
Description
Visual analogue scale of 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
Visual analogue scale (VAS) of low-back pain
Description
Visual analogue scale of 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
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
Title
Fear-Avoidance Beliefs Questionnaire (FABQ)
Description
FABQ is one of pateint-reported outcome questionnaire which consists of total 16 questions. Through FABQ, the investigator can evaluate fear avoidance responses, especially in physical and occupational activity domain for patients with low-back pain
Time Frame
week 1, 9, 14, 27
Title
Patient Global Impression of Change (PGIC)
Description
Participants rate the improvement after treatment on a 7-point Likert scale(1, very much improved; 2, much improved; 3, minimally improved; 4, nochange; 5, minimally worse; 6, much worse; or 7, very much worse.)
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Numeric rating scale (NRS) score of radiating pain 5 or more for recent 3 serial days. Onset time of radiating pain occurred within 12 weeks. Radiologically diagnosed with lumbar disc herniation in lumbar spine magnetic resonance imaging (L-spine MRI) 19-70 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 or pharmacopuncture 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, KMD,Ph.D
Organizational Affiliation
Jaseng Hospital of Korean Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jaseng Hospital of Korean Medicine
City
Seoul
ZIP/Postal Code
06110
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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