Trial | NCT03132974  Report issue

Official Title

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, Pilot Study -

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    sogyeonghwalhyeol-tang ...

  • Study Participants

    150
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
Study Started
Sep 01
2018
Primary Completion
Dec 31
2021
Anticipated
Study Completion
Dec 31
2021
Anticipated
Last Update
Mar 30
2021

Drug Sogyeonghwalhyeol-tang granule

Sogyeonghwalhyeol-tang herbal extract granule

Other Sogyeonghwalhyeol-tang granule with manipulation procedure

Sogyeonghwalhyeol-tang herbal extract granule with manipulation procedure

Other Placebo with manipulation procedure

Placebo granule with manipulation procedure

SGHH Experimental

Admission to Sogyeonghwalhyeol-tang granule

SGHH with manipulation therapy Experimental

Admission to Sogyeonghwalhyeol-tang granule and manipulation therapy

Placebo with manipulation therapy Placebo Comparator

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
No Results Posted