Evaluation of the Efficacy and Safety of Herbal Medicine for Treating Work-related Chronic Low Back Pain
NCT ID: NCT02988232
Last Updated: 2021-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
72 participants
INTERVENTIONAL
2016-07-01
2020-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Treatment(SGHH)
Admission to Sogyeonghwalhyeol-tang granule
Sogyeonghwalhyeol-tang
herbal extract
Placebo
admission to placebo
Placebo
extract powder with same appearance, odor and color as SGHH
Interventions
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Placebo
extract powder with same appearance, odor and color as SGHH
Sogyeonghwalhyeol-tang
herbal extract
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
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
19 Years
65 Years
ALL
No
Sponsors
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Sangji University Oriental Medical Center, Korea
UNKNOWN
Semyung University Korean Medicine Hospital in Chungju, Korea
UNKNOWN
Daejeon University
OTHER
Gachon University Gil Oriental Medical Hospital
OTHER
Responsible Party
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Yun-Kyung Song
KMD PhD
Principal Investigators
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Yun-Kyung Song, PhD
Role: PRINCIPAL_INVESTIGATOR
Gachon University of Oriental Hospital
Locations
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Gachon University Gil Oriental Medical Hospital
Incheon, , South Korea
Countries
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Other Identifiers
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ISEE_2015_WRMD
Identifier Type: -
Identifier Source: org_study_id
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