NCT02988232

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P25-P50 for phase_4 low-back-pain

Timeline
Completed

Started Jul 2016

Longer than P75 for phase_4 low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 9, 2016

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

April 12, 2021

Status Verified

April 1, 2021

Enrollment Period

4.5 years

First QC Date

December 7, 2016

Last Update Submit

April 9, 2021

Conditions

Low Back PainWorkplace

Keywords

Work Related Chronic Low Back PainKorean MedicineSogyeonghwalhyeol-tang

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Change from Baseline in 'Roland Morris Disability Questionnaire'

    Screening Visit, At baseline, week 2, 4, 6, 8

  • Change from Baseline in European Quality of life 5 Dimension

    Screening Visit, At baseline, week 2, 4, 6, 8

Study Arms (2)

Treatment(SGHH)

EXPERIMENTAL

Admission to Sogyeonghwalhyeol-tang granule

Drug: Sogyeonghwalhyeol-tang

Placebo

PLACEBO COMPARATOR

admission to placebo

Drug: Placebo

Interventions

Sogyeonghwalhyeol-tangDRUG

herbal extract

Also known as: SGHH
Treatment(SGHH)
PlaceboDRUG

extract powder with same appearance, odor and color as SGHH

Placebo

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gachon University Gil Oriental Medical Hospital

Incheon, South Korea

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yun-Kyung Song, PhD

    Gachon University of Oriental Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
KMD PhD

Study Record Dates

First Submitted

December 7, 2016

First Posted

December 9, 2016

Study Start

July 1, 2016

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

April 12, 2021

Record last verified: 2021-04

Locations

KR(1)