Skip to main content
OpenTrials
Completed

NCT Number: NCT02988232

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Workplace

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Gachon University Gil Oriental Medical Hospital

Incheon, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sogyeonghwalhyeol-tang

Drug

herbal extract

Other names: SGHH

Placebo

Drug

extract powder with same appearance, odor and color as SGHH

Primary outcomes

  1. Change from Baseline in Numeric Rating Scale of Pain

    Time frame: 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 outcomes

  1. Change from Baseline in 'Roland Morris Disability Questionnaire'

    Time frame: 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.

  2. Change from Baseline in European Quality of life 5 Dimension

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Gachon University Gil Oriental Medical Hospital

Other

Collaborators

  • Daejeon University
  • Sangji University Oriental Medical Center, Korea
  • Semyung University Korean Medicine Hospital in Chungju, Korea

Registry information

Official study title

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

Acronym: WRMD

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Dec 9, 2016
Registry last updated
Apr 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.