Overview

Evaluation of Efficacy and Safety of Single and Multiple Therapy of Herbal Medicine/Chuna Therapy on Non-specific Chronic Low Back Pain: A Study Protocol for Multicenter, 3-arm, Randomized, Single Blinded, Parallel Group, Incomplete Factorial Design

Status:
Recruiting
Trial end date:
2021-12-31
Target enrollment:
0
Participant gender:
All
Summary
The Purpose of this trial is to investigate the efficacy and safety of herbal medicine with manipulation therapy on Korean Patients with Chronic Low Back Pain
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gachon University Gil Oriental Medical Hospital
Collaborators:
Daejeon University
Dunsan Korean Medicine Hospital of Daejeon University
Semyung University Korean Medicine Hospital in Chungju
Woosuk University Oriental Medical Center
Criteria
Inclusion Criteria:

- Inpatients with chief complaint of low back pain in oriental rehabilitation medical
center

- Age 19 - 65

- Patients who have 4 ~7 cm of VAS pain score;

- 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