Chronic Low Back Pain
Conditions
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
Interventions
DRUGSogyeonghwalhyeol-tang granule
Sogyeonghwalhyeol-tang herbal extract granule
OTHERSogyeonghwalhyeol-tang granule with manipulation procedure
Sogyeonghwalhyeol-tang herbal extract granule with manipulation procedure
OTHERPlacebo with manipulation procedure
Placebo granule with manipulation procedure
Sponsors
Daejeon University
Semyung University Korean Medicine Hospital in Chungju
Woosuk University Oriental Medical Center
Gachon University Gil Oriental Medical Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in pelvic incidence | At baseline, week 4, 8 | angle between the line perpendicular to the sacral plate and the line connecting the midpoint of the sacral plate to the bicoxofemoral axis. |
| Change from baseline in lumbar lordotic angle | At baseline, week 4, 8 | the angle between the top (superior surface) of the second lumbar vertebra and the bottom (inferior surface) of the fifth lumbar vertebra |
| Change from baseline in iliac crest height | At baseline, week 4, 8 | A measure of the vertical distance from the top of the iliac crest to the floor while the subject stands. |
| Change from baseline in lumbar gravity line | At baseline, week 4, 8 | created by first locating center of the L3 body & then droping a line downward from there, perpendicular to the bottom of the film. |
Countries
South Korea
Contacts
Primary ContactYoume Ko, MA
Outcome results
None listed