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

ABSTRACT: 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.

SUBMITTER: Ko Y

PROVIDER: S-EPMC7360851 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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

Ko Youme Y Jang Bo-Hyoung BH Oh Min-Seok MS Shin Byung-Cheul BC Kim Sun Joong SJ Cha Yun-Yeop YY Ko Youn Seok YS Hwang Eui-Hyoung EH Lee Eun Jung EJ Jung Jae Young JY Song Yun-Kyung YK Ko Seong-Gyu SG

Integrative medicine research 20200608 4

<h4>Background</h4>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 decision ...[more]

PMID: 32695577

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Project description:BackgroundChronic pain affects nearly 116 million American adults at an estimated cost of up to $635 billion annually and is the No. 1 condition for which patients seek care at integrative medicine clinics. In our Study on Integrative Medicine Treatment Approaches for Pain (SIMTAP), we observed the impact of an integrative approach on chronic pain and a number of other related patient-reported outcome measures.MethodsOur prospective, non-randomized, open-label observational evaluation was conducted over six months, at nine clinical sites. Participants received a non-standardized, personalized, multimodal approach to chronic pain. Validated instruments for pain (severity and interference levels), quality of life, mood, stress, sleep, fatigue, sense of control, overall well-being, and work productivity were completed at baseline and at six, 12, and 24 weeks. Blood was collected at baseline and week 12 for analysis of high-sensitivity C-reactive protein and 25-hydroxyvitamin D levels. Repeated-measures analysis was performed on data to assess change from baseline at 24 weeks.ResultsOf 409 participants initially enrolled, 252 completed all follow-up visits during the 6 month evaluation. Participants were predominantly white (81%) and female (73%), with a mean age of 49.1 years (15.44) and an average of 8.0 (9.26) years of chronic pain. At baseline, 52% of patients reported symptoms consistent with depression. At 24 weeks, significantly decreased pain severity (-23%) and interference (-28%) were seen. Significant improvements in mood, stress, quality of life, fatigue, sleep and well-being were also observed. Mean 25-hydroxyvitamin D levels increased from 33.4 (17.05) ng/mL at baseline to 39.6 (16.68) ng/mL at week 12.ConclusionsAmong participants completing an integrative medicine program for chronic pain, significant improvements were seen in pain as well as other relevant patient-reported outcome measures.Trial registrationClinicalTrials.gov, NCT01186341.

Project description:Low back pain accounts for nearly 4 million emergency department (ED) visits annually and is a significant source of disability. Physical therapy has been suggested as a potentially effective nonopioid treatment for low back pain; however, no studies to our knowledge have yet evaluated the emerging resource of ED-initiated physical therapy. The study objective was to compare patient-reported outcomes in patients receiving ED-initiated physical therapy and patients receiving usual care for acute low back pain. This was a prospective observational study of ED patients receiving either physical therapy or usual care for acute low back pain from May 1, 2018, to May 24, 2019, at a single academic ED (>91,000 annual visits). The primary outcome was pain-related functioning, assessed with Oswestry Disability Index (ODI) and Patient-Reported Outcomes Measurement Information System pain interference (PROMIS-PI) scores. The secondary outcome was use of high-risk medications (opioids, benzodiazepines, and skeletal muscle relaxants). Outcomes were compared over 3 months using adjusted linear mixed and generalized estimating equation models. For 101 participants (43 receiving ED-initiated physical therapy and 58 receiving usual care), the median age was 40.5 years and 59% were women. Baseline outcome scores in the ED-initiated physical therapy group were higher than those in the usual care group (ODI = 51.1 vs 36.0; PROMIS-PI = 67.6 vs 62.7). Patients receiving ED-initiated physical therapy had greater improvements in both ODI and PROMIS-PI scores at the 3-month follow-up (ODI = -14.4 [95% CI = -23.0 to -5.7]; PROMIS-PI = -5.1 [95% CI = -9.9 to -0.4]) and lower use of high-risk medications (odds ratio = 0.05 [95% CI = 0.01 to 0.58]). In this single-center observational study, ED-initiated physical therapy for acute low back pain was associated with improvements in functioning and lower use of high-risk medications compared with usual care; the causality of these relationships remains to be explored. ED-initiated physical therapy is a promising therapy for acute low back pain that may reduce reliance on high-risk medications while improving patient-reported outcomes. Emergency department-initiated physical therapy for low back pain was associated with greater improvement in functioning and lower use of high-risk medications over 3 months.

Project description:OBJECTIVES:Chronic low-back pain (CLBP) is burdensome and costly, and a common condition for which adults use integrative therapies. The effectiveness of multidisciplinary integrative approaches has not been well studied. The purpose of this observational study was to compare characteristics and outcomes of CLBP patients treated at the Osher Clinical Center (OCC) versus other clinics at Brigham and Women's Hospital. DESIGN:Observational comparative effectiveness study. SETTING:Tertiary care hospital. SUBJECTS:Patients ?21 years with 3+ months of CLBP or 6+ months of intermittent low-back pain. INTERVENTION:All patients were observed for 12 months. OCC patients received care at the integrative clinic (7.3 visits on average over 13 weeks); non-OCC patients received usual care at other clinics of the same hospital. OUTCOME MEASURES:Primary outcomes: change from baseline to 6 months in functional status (Roland Disability Questionnaire [RDQ]) and bothersomeness of pain (BOP). SECONDARY OUTCOMES:change in RDQ and BOP at 3 and 12 months, percentages of patients with clinically meaningful (?30%) improvements. RESULTS:One hundred fifty-six OCC and 153 non-OCC participants were enrolled; follow-up was 90.4 and 98.0%, respectively, at 12 months. There were substantial differences in baseline characteristics between groups. For RDQ, the adjusted mean group difference was nonsignificant at 6 months; for BOP, the differences were significant, but clinically small. At 12 months, the observed benefit on RDQ was significant and clinically meaningful; for BOP, there were significant, but clinically small differences. Percentages of patients with ?30% improvements in RDQ were significantly greater in the OCC group only at 12 months, and both 6 and 12 months for BOP. CONCLUSIONS:Baseline characteristics can differ between those who select different sources of healthcare for CLBP. While benefits seen in the OCC versus non-OCC clinics were not large, further evaluation through randomized trials might be warranted to provide a more definitive evaluation.

Dataset Information

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

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

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