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