Korean medicine registry for low back pain – A study protocol for prospective observational multi-center study (KLOS)

BACKGROUND: Low back pain (LBP) is a major burden in Korea. Despite its high prevalence, the government and the public health sector do not address the specific evidences of symptom control and prevention of LBP to reduce long-term healthcare costs and increase the quality of life. Thus, the Korean medicine sector encourages to collection and analysis of the medical utilization pattern of patients with LBP in Korea to provide evidences of LBP control strategy as well as political decisions. METHODS: KLOS, a prospective, multi-center, patient registry pilot study will collaborate with 7 traditional Korean medicine hospitals and recruit patients with LBP into the registry. A total of 150 eligible patients with new episodes of LBP, who visit a Korean hospital without any other treatment history, will be enrolled in the registry. After enrollment, we will collect the individual characteristics of each patient, such as pain intensity, LBP-related daily disability, anthropometrics, and Health-Related Quality of Life (HRQoL) at baseline and FU1 and FU2. We will also access the patients’ 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 patients with new episodes of LBP and (2) evaluate the efficacy and safety of various Korean medicine treatments for LBP, based on nationwide registry outcome collecting process. DISCUSSION: The first pilot study of prospective, multi-center registry of newly diagnosed LBP patients in traditional Korean medicine hospitals. The result of this study may show the current status of LBP patients who receive Korean medicine treatments and provide evidences for reasonable decision-making on Korean medicine healthcare policy in the future. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Identifier: NCT02418286.