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

Phase 4

Completed

• Conditions: Low Back Pain; Workplace
• Interventions: Drug: Sogyeonghwalhyeol-tang; Drug: Placebo

• Registration Number: NCT02988232
• Lead Sponsor: Gachon University Gil Oriental Medical Hospital

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

Study Timeline

• Study Start: 2016-07-01
• Study First Submitted: 2016-12-07
• Study First Submitted QC: 2016-12-07
• Study First Posted: 2016-12-09
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-09
• Last Update Posted: 2021-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment(SGHH)	Sogyeonghwalhyeol-tang	Admission to Sogyeonghwalhyeol-tang granule
Placebo	Placebo	admission to placebo

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Gachon University Gil Oriental Medical Hospital; 🇰🇷 Incheon, Korea, Republic of