Pain Clinical Trial
— KLOSOfficial title:
KLOS Study - Korean Medicine Registry for Low Back Pain Patients, a Prospective, Observational, Multicenter, Pilot Study
NCT number | NCT02418286 |
Other study ID # | 14-102 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 2015 |
Est. completion date | December 31, 2020 |
Verified date | March 2021 |
Source | Gachon University Gil Oriental Medical Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 150 |
Est. completion date | December 31, 2020 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Gachon University, Gil Oriental Medicine Center | Incheon |
Lead Sponsor | Collaborator |
---|---|
Gachon University Gil Oriental Medical Hospital | Daejeon University, Kyunghee University Medical Center, Pusan National University Korean Medicine Hospital, Korea, Sangji University Oriental Medical Center, Korea, Semyung University Korean Medicine Hospital in Chungju, Korea, Woosuk University Oriental Medical Center, Korea |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Other | Change from Baseline in Numeric Rating Scale of Pain | 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 | |
Other | 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 | |
Primary | 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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