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| Name | Class |
|---|---|
| Sangji University Oriental Medical Center, Korea | UNKNOWN |
| Semyung University Korean Medicine Hospital in Chungju, Korea | UNKNOWN |
| Kyunghee University Medical Center | OTHER |
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The Purpose of this trial is to define the characteristics of the in/outpatients with low back pain in traditional Korean medicine rehabilitation clinic. This information will create a registry that will help us to compare similarities and differences in patients and their symptoms. The more patients the investigators are able to enter into the registry, the more the investigators will be able to understand the low back pain and learn better ways of caring for patients.
KLOS, prospective, multi-center, patient registry pilot study will collaborate with 7 Korean medicine hospitals and plan to recruit low back pain patients into the registry. 150 eligible patients with new episode of LBP who visit Korean medicine hospital without any other treatment history will enroll to the registry. After enrollment, study collect the individual characteristics of patient's status such as pain intensity, LBP related daily disability, anthropometrics, HRQoL at baseline, 30 and 90 days. We also access to the patient's clinical and administrative electronic records to analyze the pattern of patients' resource utilization. Overall, the aims of KLOS are to: 1) explore the general characteristics of new episode of LBP patients and; 2) evaluate the efficacy and safety of various Korean medicine treatments on low back pain based on nationwide registry outcome collecting process.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Back Pain Participant Registry | Patients with low back pain in traditional Korean medicine rehabilitation clinic |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| expose to any drugs or procedures based on traditional Korean medicine theory | Other | There are no specific interventions associated with this registry as it is purely observational study of medical utilization. |
| 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. | at Baseline, 30 days after registration |
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| 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 | at Baseline, 90 days after registration |
| Change from Baseline in Numeric Rating Scale of Pain |
Inclusion Criteria:
Exclusion Criteria:
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Patients with low back pain who are visiting oriental rehabiliation clinic
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| Name | Affiliation | Role |
|---|---|---|
| Yun-Kyung Song, KMD, PhD, Professor | Gachon University, Gil Oriental Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gachon University, Gil Oriental Medicine Center | Incheon | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32695577 | Derived | Ko Y, Jang BH, Oh MS, Shin BC, Kim SJ, Cha YY, Ko YS, Hwang EH, Lee EJ, Jung JY, Song YK, Ko SG. Korean medicine registry for low back pain - A study protocol for prospective observational multi-center study (KLOS). Integr Med Res. 2020 Dec;9(4):100448. doi: 10.1016/j.imr.2020.100448. Epub 2020 Jun 8. |
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| Woosuk University Oriental Medical Center, Korea |
| UNKNOWN |
| Daejeon University | OTHER |
| Pusan National University | OTHER |
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A 10-point Numerical Pain Rating Scale (NRS; 0: no pain, 10: maximum pain) assesses the patients' current level of pain. |
| at Baseline, 30 days after registration and 90 days after registration |
| 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. | at Baseline, 30 days after registration and 90 days after registration |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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