Low Back Pain, Workplace
Conditions
Keywords
Work Related Chronic Low Back Pain, Korean Medicine, Sogyeonghwalhyeol-tang
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
Interventions
DRUGSogyeonghwalhyeol-tang
herbal extract
DRUGPlacebo
extract powder with same appearance, odor and color as SGHH
Sponsors
Sangji University Oriental Medical Center, Korea
Semyung University Korean Medicine Hospital in Chungju, Korea
Daejeon University
Gachon University Gil Oriental Medical Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Numeric Rating Scale of Pain | Screening Visit, At baseline, week 2, 4, 6, 8 | A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) assesses the patients' current level of pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in 'Roland Morris Disability Questionnaire' | Screening Visit, At baseline, week 2, 4, 6, 8 | 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 | Screening Visit, At baseline, week 2, 4, 6, 8 | 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. |
Countries
South Korea
Outcome results
None listed