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

March 27, 2021 updated by: Yun-Kyung Song, Gachon University Gil Oriental Medical Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Incheon, Korea, Republic of
        • Gachon University, Gil Oriental Medicine Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with low back pain who are visiting oriental rehabiliation clinic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Low Back Pain Participant Registry
Patients with low back pain in traditional Korean medicine rehabilitation clinic
Other: expose 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in 'Roland Morris Disability Questionnaire'
Time Frame: 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.
at Baseline, 30 days after registration

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in 'Roland Morris Disability Questionnaire'
Time Frame: 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
at Baseline, 90 days after registration
Change from Baseline in Numeric Rating Scale of Pain
Time Frame: 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.
at Baseline, 30 days after registration and 90 days after registration
Change from Baseline in European Quality of life 5 Dimension
Time Frame: 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.
at Baseline, 30 days after registration and 90 days after registration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gachon University Gil Oriental Medical Hospital

Collaborators

Kyunghee University Medical Center
Daejeon University
Sangji University Oriental Medical Center, Korea
Semyung University Korean Medicine Hospital in Chungju, Korea
Woosuk University Oriental Medical Center, Korea
Pusan National University Korean Medicine Hospital, Korea

Investigators

  • Principal Investigator: Yun-Kyung Song, KMD, PhD, Professor, Gachon University, Gil Oriental Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

April 6, 2015

First Submitted That Met QC Criteria

April 15, 2015

First Posted (Estimate)

April 16, 2015

Study Record Updates

Last Update Posted (Actual)

March 30, 2021

Last Update Submitted That Met QC Criteria

March 27, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Nervous System Diseases

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe