Back Pain, Low Back Pain, Nervous System Diseases, Neurologic Manifestations, Pain
Conditions
Keywords
Low Back Pain, Korean Rehabilitation Clinic, Patient Registry
Brief summary
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
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.
Interventions
OTHERexpose to any drugs or procedures based on traditional Korean medicine theory
There are no specific interventions associated with this registry as it is purely observational study of medical utilization.
Sponsors
Sangji University Oriental Medical Center, Korea
Semyung University Korean Medicine Hospital in Chungju, Korea
Kyunghee University Medical Center
Woosuk University Oriental Medical Center, Korea
Daejeon University
Pusan National University Korean Medicine Hospital, Korea
Gachon University Gil Oriental Medical Hospital
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in 'Roland Morris Disability Questionnaire' | at Baseline, 30 days after registration | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in 'Roland Morris Disability Questionnaire' | at Baseline, 90 days after registration | This is a self-reported questionnaire consisting of 24 items reflecting limitations in different activities of daily living attributed to low back pain |
| Change from Baseline in Numeric Rating Scale of Pain | at Baseline, 30 days after registration and 90 days after registration | A 10-point Numerical Pain Rating Scale (NRS; 0: no pain, 10: maximum pain) assesses the patients' current level of pain. |
| Change from Baseline in European Quality of life 5 Dimension | at Baseline, 30 days after registration and 90 days after registration | 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. |
Countries
South Korea
Outcome results
None listed