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| Name | Class |
|---|---|
| Daejeon University | OTHER |
| Semyung University Korean Medicine Hospital in Chungju | UNKNOWN |
| Woosuk University Oriental Medical Center | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SGHH | Experimental | Admission to Sogyeonghwalhyeol-tang granule |
|
| SGHH with manipulation therapy | Experimental | Admission to Sogyeonghwalhyeol-tang granule and manipulation therapy |
|
| Placebo with manipulation therapy | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sogyeonghwalhyeol-tang granule | Drug | Sogyeonghwalhyeol-tang herbal extract granule |
| |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in pelvic incidence | angle between the line perpendicular to the sacral plate and the line connecting the midpoint of the sacral plate to the bicoxofemoral axis. | At baseline, week 4, 8 |
| Change from baseline in iliac crest height |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Youme Ko, MA | Contact | 8229619278 | iseeymk@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yun-Kyung Song, PhD | Gachon University Gil Oriental Medical Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gachon University Gil Oriental Medicine Hospital | Recruiting | Incheon | 22318 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32791704 | Derived | Ko Y, Jang BH, Oh MS, Kim SJ, Ko YS, Ha IH, Lee EJ, Kim MR, Song YK, Ko SG. 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. Medicine (Baltimore). 2020 Jul 24;99(30):e21260. doi: 10.1097/MD.0000000000021260. |
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| Sogyeonghwalhyeol-tang granule with manipulation procedure |
| Other |
Sogyeonghwalhyeol-tang herbal extract granule with manipulation procedure |
|
| Placebo with manipulation procedure | Other | Placebo granule with manipulation procedure |
|
| 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 |
A measure of the vertical distance from the top of the iliac crest to the floor while the subject stands.
| At baseline, week 4, 8 |
| Change from baseline in lumbar gravity line | created by first locating center of the L3 body & then droping a line downward from there, perpendicular to the bottom of the film. | At baseline, week 4, 8 |
| Change from baseline in lumbar lordotic angle | the angle between the top (superior surface) of the second lumbar vertebra and the bottom (inferior surface) of the fifth lumbar vertebra | At baseline, week 4, 8 |