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

Study Overview
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Brief Summary
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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
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Investigating the efficacy and safety of Sogyeonghwalhyeol-tang(SGHH) on Korean Patients With Work-related Chronic Low Back Pain

Official Title
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Evaluation of the Efficacy and Safety of Herbal Medicine for Treating Work-related Chronic Low Back Pain: a Multicenter, Randomized, Controlled, Clinical Trial

Conditions
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Low Back Pain, Workplace

Intervention / Treatment
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* Drug: Sogyeonghwalhyeol-tang
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment(SGHH)<br>Admission to Sogyeonghwalhyeol-tang granule | Drug: Sogyeonghwalhyeol-tang<br>* herbal extract<br>* Other names: SGHH;|
| Placebo Comparator: Placebo<br>admission to placebo | Drug: Placebo<br>* extract powder with same appearance, odor and color as SGHH<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Screening Visit, At baseline, week 2, 4, 6, 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Screening Visit, At baseline, week 2, 4, 6, 8 | 
| 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. | Screening Visit, At baseline, week 2, 4, 6, 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Work Related Chronic Low Back Pain, Korean Medicine, Sogyeonghwalhyeol-tang