Clinical trial NCT02418286: KLOS Study - Korean Medicine Registry for Low Back Pain Patients, a Prospective, Observational, Multicenter, Pilot Study
Official title: KLOS Study - Korean Medicine Registry for Low Back Pain Patients, a Prospective, Observational, Multicenter, Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Keywords: Low Back Pain
Korean Rehabilitation Clinic
Patient Registry
Lead sponsor: Gachon University Gil Oriental Medical Hospital
Sponsor class: OTHER
Collaborators: name: Sangji University Oriental Medical Center, Korea
name: Semyung University Korean Medicine Hospital in Chungju, Korea
name: Kyunghee University Medical Center
name: Woosuk University Oriental Medical Center, Korea
name: Daejeon University
name: Pusan National University Korean Medicine Hospital, Korea
First posted: 2015-04-16
Enrollment: 150
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with low back pain who are visiting oriental rehabiliation clinic

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in 'Roland Morris Disability Questionnaire'
timeFrame: at Baseline, 30 days after registration
Secondary outcomes:
Other outcomes:
measure: Change from Baseline in 'Roland Morris Disability Questionnaire'
timeFrame: at Baseline, 90 days after registration
measure: Change from Baseline in Numeric Rating Scale of Pain
timeFrame: at Baseline, 30 days after registration and 90 days after registration
measure: Change from Baseline in European Quality of life 5 Dimension
timeFrame: at Baseline, 30 days after registration and 90 days after registration
Locations:
city: Incheon
country: Korea, Republic of
facility: Gachon University, Gil Oriental Medicine Center
Study officials:
affiliation: Gachon University, Gil Oriental Medical Center
name: Yun-Kyung Song, KMD, PhD, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.