Low Back PainKLOSNCT02418286
KLOS Study - Korean Medicine Registry for Low Back Pain Patients, a Prospective, Observational, Multicenter, Pilot Study
An observational study of Low Back Pain and Back Pain, run by Gachon University Gil Oriental Medical Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Low Back Pain, Back Pain, Pain
- What is being tested?
- expose to any drugs or procedures based on traditional Korean medicine theory
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2015to 31 Dec 2020
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with low back pain who are visiting oriental rehabiliation clinic
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- expose to any drugs or procedures based on traditional Korean medicine theory
- Keywords
- Low Back Pain, Korean Rehabilitation Clinic, Patient Registry
- Medical subject headings
- Low Back Pain, Back Pain, Pain, Neurologic Manifestations, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
expose to any drugs or procedures based on traditional Korean medicine theoryOther
There are no specific interventions associated with this registry as it is purely observational study of medical utilization.
| Study group | Role | What they receive |
|---|---|---|
| Low Back Pain Participant Registry | Patients with low back pain in traditional Korean medicine rehabilitation clinic Receives: Other: expose to any drugs or procedures based on traditional Korean medicine theory |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at Baseline, 30 days after registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2015 (estimated)
- Study startMar 2015
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Oriental Medical Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sangji University Oriental Medical Center, Korea, Semyung University Korean Medicine Hospital in Chungju, Korea, Kyunghee University Medical Center, Woosuk University Oriental Medical Center, Korea, Daejeon University, Pusan National University
- Responsible party
- Principal investigator, Yun-Kyung Song, Gachon University Gil Oriental Medical Hospital
- Investigators
- Yun-Kyung Song, KMD, PhD, Professor, Principal investigator, Gachon University, Gil Oriental Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02418286
- Sponsor's protocol ID
- 14-102
- Acronym
- KLOS
- Status last verified
- Mar 2021
- First submitted
- 6 Apr 2015
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32695577
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KLOS Study - Korean Medicine Registry for Low Back Pain Patients, a Prospective, Observational, Multicenter, Pilot Study
- ClinicalTrials.gov ID
- NCT02418286
- Acronym / sponsor ID
- KLOS / 14-102
- Keywords
- Low Back Pain, Korean Rehabilitation Clinic, Patient Registry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Gachon University Gil Oriental Medical HospitalUniversity, hospital or other
- Collaborators
- Sangji University Oriental Medical Center, Korea, Semyung University Korean Medicine Hospital in Chungju, Korea, Kyunghee University Medical Center, Woosuk University Oriental Medical Center, Korea, Daejeon University, Pusan National University
- Study start
- Mar 2015
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 16 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low Back Pain Participant Registry | – | Other: expose to any drugs or procedures based on traditional Korean medicine theoryPatients with low back pain in traditional Korean medicine rehabilitation clinic |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with low back pain who are visiting oriental rehabiliation clinic
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| expose to any drugs or procedures based on traditional Korean medicine theoryThere are no specific interventions associated with this registry as it is purely observational study of medical utilization. | Other | Low Back Pain Participant Registry |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Derived from this study: PubMed 32695577Ko 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yun-Kyung Song, KMD, PhD, Professor principal investigator
Gachon University, Gil Oriental Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain and Back Pain, run by Gachon University Gil Oriental Medical Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in 'Roland Morris Disability Questionnaire' (time frame: at Baseline, 30 days after registration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02418286, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2021.