Evaluation of Efficacy and Safety of Herbal Medicine on Work related Chronic Low Back Pain

Evaluation of Efficacy and Safety of Herbal Medicine on Work related Chronic Low Back Pain - Multicenter, Randomized, Double Blinded, Parallel Group, Placebo Controlled Pilot study -

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0002177

Enrollment

Registered

2016-12-23

Start date

2016-07-29

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Sogyeonghwalhyeol-tang and Placebo groups take prescribed medication orally , 3g each time, 3 times per day, each taken before or between meals for 4 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Inpatients with Chief Complaint of Low Back Pain in Oriental Rehabilitation Medical Center 2) Age 19 - 65 3) Occupations Designated As High-Risk Or Safety-Sensitive to low back pain(hospital worker, office worker, blue collar, vehicle driver) 4) Satisfying all of the following criteria - Numeric rating scale 4-7 points - Diagnosed with at-risk worker or worker with pain by using musculoskeletal disorder questionnaire(KOSHA) 5) Ability to have normal communication 6) Ability to give informed consent

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
numeric rating scale	—

Secondary

Measure	Time frame
Roland Morris Disability Questionnaire ;European Quality of life 5 Dimension ;Adverse Events;Liver function test	—

Countries

Korea, Republic of

Contacts

Public ContactYoume Ko

Kyung Hee University

ymymko84@gmail.com+82-2-961-9278

Outcome results