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Evaluation of the Efficacy and Safety of Herbal Medicine for Treating Work-related Chronic Low Back Pain (WRMD)

Primary Purpose

Low Back Pain, Workplace

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Sogyeonghwalhyeol-tang
Placebo
Sponsored by
Gachon University Gil Oriental Medical Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Work Related Chronic Low Back Pain, Korean Medicine, Sogyeonghwalhyeol-tang

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Inpatients with chief complaint of low back pain in oriental rehabilitation medical center
  • Age 19 - 65
  • Workplace Vulnerable populations(hospital workers, office worker, blue collar workers, transit workers)

  • Patients must include all of the following symptoms:

    • Those who have 4 ~7 cm of VAS pain score;
    • Those who has classified as 'at risk non-complier' or 'pain complaints' by KOSHA questionnaire
  • Ability to have normal communication
  • Ability to give informed consent

Exclusion Criteria:

  1. Patients with pain duration of 3 months or less
  2. Patients with progressive neurologic deficit or severe neurologic symptoms by SLR test
  3. Patients diagnosed with serious pathology(s) which may cause low back pain (e.g. spinal metastasis of tumor(s), acute fracture, etc)
  4. Patients with spondylolisthesis or spondylolysis(diagnosed with grade II or higher level)
  5. Patients currently taking steroids, immunosuppressants, medicine for mental illness or other medication(s) that may interfere with study results
  6. Patients with history of spinal surgery
  7. Patients with more severe pain than pain caused by low back pain
  8. Those who do not (cannot) abide by treatment and follow up due to the mental illness such as behavior disorder, depression, anxiety neurosis etc.
  9. Patients with history of Medical Malpractice Case
  10. Patients with treatment history of low back pain within 1 month either KM or WM
  11. Patients participating in other clinical studies within 3 months
  12. Pregnant patients or patients with plans of pregnancy or lactating patients
  13. Patients disagree to sign the informed consent form
  14. Patients deemed unsuitable for participating the trial by the researchers

Sites / Locations

  • Gachon University Gil Oriental Medical Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment(SGHH)

Placebo

Arm Description

Admission to Sogyeonghwalhyeol-tang granule

admission to placebo

Outcomes

Primary Outcome Measures

Change from Baseline in Numeric Rating Scale of Pain
A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) assesses the patients' current level of pain.

Secondary Outcome Measures

Change from Baseline in 'Roland Morris Disability Questionnaire'
This is a self-reported questionnaire consisting of 24 items reflecting limitations in different activities of daily living attributed to low back pain including walking, bending over, sitting, lying down, dressing, sleeping, self-care and daily activities.
Change from Baseline in European Quality of life 5 Dimension
The EQ-5D is an international, standardized, generic instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state.

Full Information

First Posted
December 7, 2016
Last Updated
April 9, 2021
Sponsor
Gachon University Gil Oriental Medical Hospital
Collaborators
Sangji University Oriental Medical Center, Korea, Semyung University Korean Medicine Hospital in Chungju, Korea, Daejeon University
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1. Study Identification

Unique Protocol Identification Number
NCT02988232
Brief Title
Evaluation of the Efficacy and Safety of Herbal Medicine for Treating Work-related Chronic Low Back Pain
Acronym
WRMD
Official Title
Evaluation of the Efficacy and Safety of Herbal Medicine for Treating Work-related Chronic Low Back Pain: a Multicenter, Randomized, Controlled, Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gachon University Gil Oriental Medical Hospital
Collaborators
Sangji University Oriental Medical Center, Korea, Semyung University Korean Medicine Hospital in Chungju, Korea, Daejeon University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The Purpose of this trial is to investigate the efficacy and safety of Sogyeonghwalhyeol-tang(SGHH) on Korean Patients With Work Related Chronic Low Back Pain
Detailed Description
Investigating the efficacy and safety of Sogyeonghwalhyeol-tang(SGHH) on Korean Patients With Work-related Chronic Low Back Pain

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Workplace
Keywords
Work Related Chronic Low Back Pain, Korean Medicine, Sogyeonghwalhyeol-tang

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment(SGHH)
Arm Type
Experimental
Arm Description
Admission to Sogyeonghwalhyeol-tang granule
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
admission to placebo
Intervention Type
Drug
Intervention Name(s)
Sogyeonghwalhyeol-tang
Other Intervention Name(s)
SGHH
Intervention Description
herbal extract
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
extract powder with same appearance, odor and color as SGHH
Primary Outcome Measure Information:
Title
Change from Baseline in Numeric Rating Scale of Pain
Description
A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) assesses the patients' current level of pain.
Time Frame
Screening Visit, At baseline, week 2, 4, 6, 8
Secondary Outcome Measure Information:
Title
Change from Baseline in 'Roland Morris Disability Questionnaire'
Description
This is a self-reported questionnaire consisting of 24 items reflecting limitations in different activities of daily living attributed to low back pain including walking, bending over, sitting, lying down, dressing, sleeping, self-care and daily activities.
Time Frame
Screening Visit, At baseline, week 2, 4, 6, 8
Title
Change from Baseline in European Quality of life 5 Dimension
Description
The EQ-5D is an international, standardized, generic instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state.
Time Frame
Screening Visit, At baseline, week 2, 4, 6, 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inpatients with chief complaint of low back pain in oriental rehabilitation medical center Age 19 - 65 Workplace Vulnerable populations(hospital workers, office worker, blue collar workers, transit workers) Patients must include all of the following symptoms: Those who have 4 ~7 cm of VAS pain score; Those who has classified as 'at risk non-complier' or 'pain complaints' by KOSHA questionnaire Ability to have normal communication Ability to give informed consent Exclusion Criteria: Patients with pain duration of 3 months or less Patients with progressive neurologic deficit or severe neurologic symptoms by SLR test Patients diagnosed with serious pathology(s) which may cause low back pain (e.g. spinal metastasis of tumor(s), acute fracture, etc) Patients with spondylolisthesis or spondylolysis(diagnosed with grade II or higher level) Patients currently taking steroids, immunosuppressants, medicine for mental illness or other medication(s) that may interfere with study results Patients with history of spinal surgery Patients with more severe pain than pain caused by low back pain Those who do not (cannot) abide by treatment and follow up due to the mental illness such as behavior disorder, depression, anxiety neurosis etc. Patients with history of Medical Malpractice Case Patients with treatment history of low back pain within 1 month either KM or WM Patients participating in other clinical studies within 3 months Pregnant patients or patients with plans of pregnancy or lactating patients Patients disagree to sign the informed consent form Patients deemed unsuitable for participating the trial by the researchers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yun-Kyung Song, PhD
Organizational Affiliation
Gachon University of Oriental Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gachon University Gil Oriental Medical Hospital
City
Incheon
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Evaluation of the Efficacy and Safety of Herbal Medicine for Treating Work-related Chronic Low Back Pain

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