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 -

Study Overview
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Brief Summary
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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

Official Title
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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 -

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Drug: Sogyeonghwalhyeol-tang granule
* Other: Sogyeonghwalhyeol-tang granule with manipulation procedure
* Other: Placebo with manipulation procedure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SGHH<br>Admission to Sogyeonghwalhyeol-tang granule | Drug: Sogyeonghwalhyeol-tang granule<br>* Sogyeonghwalhyeol-tang herbal extract granule<br>|
| Experimental: SGHH with manipulation therapy<br>Admission to Sogyeonghwalhyeol-tang granule and manipulation therapy | Other: Sogyeonghwalhyeol-tang granule with manipulation procedure<br>* Sogyeonghwalhyeol-tang herbal extract granule with manipulation procedure<br>|
| Placebo Comparator: Placebo with manipulation therapy<br> | Other: Placebo with manipulation procedure<br>* Placebo granule with manipulation procedure<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in 'Roland Morris Disability Questionnaire' | 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. | Screening Visit, At baseline, week 2, 4, 6, 8 | 
| Change from Baseline in European Quality of life 5 Dimension | 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. | Screening Visit, At baseline, week 2, 4, 6, 8 |