KLOS Study - Korean Medicine Registry for Low Back Pain Patients, a Prospective, Observational, Multicenter, Pilot Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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KLOS Study - Korean Medicine Registry for Low Back Pain Patients, a Prospective, Observational, Multicenter, Pilot Study

Conditions
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Low Back Pain, Back Pain, Pain, Neurologic Manifestations, Nervous System Diseases

Intervention / Treatment
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* Other: expose to any drugs or procedures based on traditional Korean medicine theory


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inpatients with chief complaint of low back pain in Korean medicine rehabilitation center Age greater than or equal to 19 Ability to have normal communication Ability to give informed consent Exclusion Criteria: Patients with low back pain which caused by other diseases(ex. lumbar herniated disc-surgery within past 3 months, vertebral fracture, inflammatory spondylitis, spinal infection, metastatic cancer etc.); Patient with musculoskeletal pain which is more severe than lower back pain; Patients with chronic disease may affect the results of clinical trial; Treated with medication for low back pain within past 4 months; Participated in other low back pain clinical trials within past 1 month; Patients who are Inability to communicate, such as alzheimer's disease or mild cognitive impairment; Pregnant women; Patients who are judged to be inappropriate for the clinical study by the researchers

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Low Back Pain Participant Registry<br>Patients with low back pain in traditional Korean medicine rehabilitation clinic | Other: expose to any drugs or procedures based on traditional Korean medicine theory<br>* There are no specific interventions associated with this registry as it is purely observational study of medical utilization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low Back Pain, Korean Rehabilitation Clinic, Patient Registry