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

Pain Clinical Trial

— KLOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02418286
• Other study ID #: 14-102
• Status: Completed
• Start date: March 2015
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2021
• Source: Gachon University Gil Oriental Medical Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Gachon University, Gil Oriental Medicine Center	Incheon

Sponsors (7)

Lead Sponsor	Collaborator
Gachon University Gil Oriental Medical Hospital	Daejeon University, Kyunghee University Medical Center, Pusan National University Korean Medicine Hospital, Korea, Sangji University Oriental Medical Center, Korea, Semyung University Korean Medicine Hospital in Chungju, Korea, Woosuk University Oriental Medical Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	at Baseline, 90 days after registration
Other	Change from Baseline in Numeric Rating Scale of Pain	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
Other	Change from Baseline in European Quality of life 5 Dimension	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
Primary	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