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

Gachon University Gil Oriental Medical Hospital

Status: Completed

Conditions: Neurologic Manifestations; Back Pain; Nervous System Diseases; Pain; Low Back Pain

Treatments: Other: expose to any drugs or procedures based on traditional Korean medicine theory

Study type: Observational

Funder types: Other

Identifiers

NCT02418286

14-102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 1 patient group

Low Back Pain Participant Registry

Description:

Patients with low back pain in traditional Korean medicine rehabilitation clinic

Treatment:

Other: expose to any drugs or procedures based on traditional Korean medicine theory