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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2021-12-31

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

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Detailed Description

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Conditions

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Chronic Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SGHH

Admission to Sogyeonghwalhyeol-tang granule

Group Type EXPERIMENTAL

Sogyeonghwalhyeol-tang granule

Intervention Type DRUG

Sogyeonghwalhyeol-tang herbal extract granule

SGHH with manipulation therapy

Admission to Sogyeonghwalhyeol-tang granule and manipulation therapy

Group Type EXPERIMENTAL

Sogyeonghwalhyeol-tang granule with manipulation procedure

Intervention Type OTHER

Sogyeonghwalhyeol-tang herbal extract granule with manipulation procedure

Placebo with manipulation therapy

Group Type PLACEBO_COMPARATOR

Placebo with manipulation procedure

Intervention Type OTHER

Placebo granule with manipulation procedure

Interventions

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Sogyeonghwalhyeol-tang granule

Sogyeonghwalhyeol-tang herbal extract granule

Intervention Type DRUG

Sogyeonghwalhyeol-tang granule with manipulation procedure

Sogyeonghwalhyeol-tang herbal extract granule with manipulation procedure

Intervention Type OTHER

Placebo with manipulation procedure

Placebo granule with manipulation procedure

Intervention Type OTHER

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

Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No