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 2

• Conditions: Chronic Low Back Pain
• Interventions: Other: Sogyeonghwalhyeol-tang granule with manipulation procedure; Other: Placebo with manipulation procedure; Drug: Sogyeonghwalhyeol-tang granule

• Registration Number: NCT03132974
• Lead Sponsor: Gachon University Gil Oriental Medical Hospital

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-19
• Study First Submitted QC: 2017-04-25
• Study First Posted: 2017-04-28
• Study Start: 2018-09-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-27
• Last Update Posted: 2021-03-30
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SGHH with manipulation therapy	Sogyeonghwalhyeol-tang granule with manipulation procedure	Admission to Sogyeonghwalhyeol-tang granule and manipulation therapy
Placebo with manipulation therapy	Placebo with manipulation procedure	-
SGHH	Sogyeonghwalhyeol-tang granule	Admission to Sogyeonghwalhyeol-tang granule

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Numeric Rating Scale of Pain	Screening Visit, At baseline, week 2, 4, 6, 8	A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) assesses the patients' current level of pain.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in 'Roland Morris Disability Questionnaire'	Screening Visit, At baseline, week 2, 4, 6, 8	This is a self-reported questionnaire consisting of 24 items reflecting limitations in different activities of daily living attributed to low back pain including walking, bending over, sitting, lying down, dressing, sleeping, self-care and daily activities.
Change from Baseline in European Quality of life 5 Dimension	Screening Visit, At baseline, week 2, 4, 6, 8	The EQ-5D is an international, standardized, generic instrument for describing and valuing health status. Participants were asked to indicate which of the following statements best describes their health state.

Trial Locations

Locations (1)

Gachon University Gil Oriental Medicine Hospital; 🇰🇷 Incheon, Korea, Republic of