Clinical trial NCT02988232: Evaluation of the Efficacy and Safety of Herbal Medicine for Treating Work-related Chronic Low Back Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Low Back Pain
Workplace
Keywords: Work Related Chronic Low Back Pain
Korean Medicine
Sogyeonghwalhyeol-tang
Lead sponsor: Gachon University Gil Oriental Medical Hospital
Sponsor class: OTHER
Collaborators: name: Sangji University Oriental Medical Center, Korea
name: Semyung University Korean Medicine Hospital in Chungju, Korea
name: Daejeon University
First posted: 2016-12-09
Enrollment: 72
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in Numeric Rating Scale of Pain
timeFrame: Screening Visit, At baseline, week 2, 4, 6, 8
Secondary outcomes:
measure: Change from Baseline in 'Roland Morris Disability Questionnaire'
timeFrame: Screening Visit, At baseline, week 2, 4, 6, 8
measure: Change from Baseline in European Quality of life 5 Dimension
timeFrame: Screening Visit, At baseline, week 2, 4, 6, 8
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Oriental Medical Hospital
Study officials:
affiliation: Gachon University of Oriental Hospital
name: Yun-Kyung Song, PhD
role: PRINCIPAL_INVESTIGATOR
References: