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

NCT02418286 | Completed

• 1 other identifier: 14-102
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Low Back Pain; Korean Rehabilitation Clinic; Patient Registry

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (3)

• Change from Baseline in 'Roland Morris Disability Questionnaire'

  at Baseline, 90 days after registration

• Change from Baseline in Numeric Rating Scale of Pain

  at Baseline, 30 days after registration and 90 days after registration

• Change from Baseline in European Quality of life 5 Dimension

  at Baseline, 30 days after registration and 90 days after registration

Study Arms (1)

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

Interventions

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

There are no specific interventions associated with this registry as it is purely observational study of medical utilization.

Low Back Pain Participant Registry

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with low back pain who are visiting oriental rehabiliation clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gachon University Gil Oriental Medical Hospital: lead
• Sangji University Oriental Medical Center, Korea: collaborator
• Semyung University Korean Medicine Hospital in Chungju, Korea: collaborator
• Kyunghee University Medical Center: collaborator
• Woosuk University Oriental Medical Center, Korea: collaborator
• Daejeon University: collaborator
• Pusan National University Korean Medicine Hospital, Korea: collaborator

Study Sites (1)

Gachon University, Gil Oriental Medicine Center

Incheon, South Korea

Location

Related Publications (1)

• 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.

  PMID: 32695577 DERIVED

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yun-Kyung Song, KMD, PhD, Professor

  Gachon University, Gil Oriental Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: KMD, PhD

Study Record Dates

• First Submitted: April 6, 2015
• First Posted: April 16, 2015
• Study Start: March 1, 2015
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: March 30, 2021

Record last verified: 2021-03

Locations

KR (1)