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Completed

NCT Number: NCT02418286

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

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Key information

Conditions

Low Back Pain Back Pain Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gachon University, Gil Oriental Medicine Center

Incheon, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Other outcomes

  1. 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

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Gachon University Gil Oriental Medical Hospital

Other

Collaborators

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

Registry information

Acronym: KLOS

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Apr 16, 2015
Registry last updated
Mar 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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