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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
Sogyeonghwalhyeol-tang herbal extract granule
Sogyeonghwalhyeol-tang herbal extract granule with manipulation procedure
Placebo granule with manipulation procedure
Gachon University Gil Oriental Medicine Hospital
Incheon, South Korea
RECRUITINGChange 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.
Time frame: Screening Visit, At baseline, week 2, 4, 6, 8
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.
Time frame: 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.
Time frame: Screening Visit, At baseline, week 2, 4, 6, 8
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