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 -

Gachon University Gil Oriental Medical Hospital

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Chronic Low Back Pain

Treatments: Other: Sogyeonghwalhyeol-tang granule with manipulation procedure; Other: Placebo with manipulation procedure; Drug: Sogyeonghwalhyeol-tang granule

Study type: Interventional

Funder types: Other

Identifiers

NCT03132974

ISEE_2017_LBP

Details and patient eligibility

About

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

Enrollment: 150 estimated patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups, including a placebo group

SGHH

Experimental group

Description:

Admission to Sogyeonghwalhyeol-tang granule

Treatment:

Drug: Sogyeonghwalhyeol-tang granule

SGHH with manipulation therapy

Experimental group

Description:

Admission to Sogyeonghwalhyeol-tang granule and manipulation therapy

Treatment:

Other: Sogyeonghwalhyeol-tang granule with manipulation procedure

Placebo with manipulation therapy

Placebo Comparator group

Treatment:

Other: Placebo with manipulation procedure