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

Completed

• Conditions: Low Back Pain; Pain; Nervous System Diseases; Back Pain; Neurologic Manifestations
• Interventions: Other: expose to any drugs or procedures based on traditional Korean medicine theory

• Registration Number: NCT02418286
• Lead Sponsor: Gachon University Gil Oriental Medical Hospital

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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-04-06
• Study First Submitted QC: 2015-04-15
• Study First Posted: 2015-04-16
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-27
• Last Update Posted: 2021-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Low Back Pain Participant Registry	expose to any drugs or procedures based on traditional Korean medicine theory	Patients with low back pain in traditional Korean medicine rehabilitation clinic

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Gachon University, Gil Oriental Medicine Center; 🇰🇷 Incheon, Korea, Republic of