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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 -

Unknown statusPhase 2, Phase 3NCT03132974
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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 details

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 -
Interventions
  • Drug: Sogyeonghwalhyeol-tang granule
  • Other: Sogyeonghwalhyeol-tang granule with manipulation procedure
  • Other: Placebo with manipulation procedure
Sponsor
Gachon University Gil Oriental Medical Hospital
Collaborators
Daejeon University; Semyung University Korean Medicine Hospital in Chungju; Woosuk University Oriental Medical Center
Start date
2018-09-01
Primary completion
2021-12-31
Sex
All
Age range
from 19 Years to 65 Years
Results posted
No results posted in this snapshot
Countries
South Korea
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03132974