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

Low Back Pain Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02988232
• Other study ID #: ISEE_2015_WRMD
• Status: Completed
• Phase: Phase 4
• Start date: July 1, 2016
• Est. completion date: December 30, 2020

Study information

• Verified date: April 2021
• Source: Gachon University Gil Oriental Medical Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Workplace

Intervention

Drug:
• Sogyeonghwalhyeol-tang
herbal extract
• Placebo
extract powder with same appearance, odor and color as SGHH

Locations

Country	Name	City	State
Korea, Republic of	Gachon University Gil Oriental Medical Hospital	Incheon

Sponsors (4)

Lead Sponsor	Collaborator
Gachon University Gil Oriental Medical Hospital	Daejeon University, Sangji University Oriental Medical Center, Korea, Semyung University Korean Medicine Hospital in Chungju, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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