RESUMEN
BACKGROUND: Neck pain is a highly prevalent medical condition that incurs substantial social burden. Although manual therapy is widely used for treatment of neck pain, the body of evidence supporting its effectiveness and safety is not conclusive. The aim of this study is to examine the effect, safety, and cost-effectiveness of Chuna manual therapy, a traditional Korean manual therapy for treatment of various musculoskeletal complaints. METHODS/DESIGN: This study is the protocol for a two-armed parallel, assessor-blinded, multicenter, randomized controlled trial. A total 108 patients with chronic neck pain (time to onset ≥ 3 months, numeric rating scale [NRS] of neck pain ≥ 5) will be recruited at five Korean medicine hospital sites. Participants will be allotted to one of two groups (n = 54, respectively): the Chuna manual therapy group, and the usual care (conventional physical therapy and medication treatment) group. Ten sessions of Chuna manual therapy or usual care will be administered twice a week for five weeks. Since the study design does not permit patient or physician blinding, the outcome assessor and statistician will be blinded. The primary outcome will be the visual analogue scale (VAS) of neck pain at 5 weeks after randomization. Secondary outcomes include the VAS of radiating arm pain, NRS of neck pain and radiating arm pain, Vernon-Mior neck disability index (NDI), Northwick Park neck pain questionnaire (NPQ), EuroQol-5 Dimension (EQ-5D), EQ-VAS, patient global impression of change (PGIC), economic evaluation, adverse effects, and drug consumption. Follow-up outcome assessments will be conducted at 3, 6, 9, and 12 months after randomization. DISCUSSION: This study will evaluate the comparative effectiveness of Chuna manual therapy and usual care on chronic neck pain. Adverse events, and costs and effectiveness (utility) data will be evaluated to assess safety and exploratory cost-effectiveness (economic evaluation). This study aims to provide evidence on the effectiveness, safety, and cost-effectiveness of Chuna manual therapy. TRIAL REGISTRATION: Clinical Research Information Service (CRIS), KCT0002732 . Registered on 13 March 2018. ClinicalTrials.gov, NCT03294785 . Registered on 27 September 2017.
Asunto(s)
Dolor Crónico/economía , Dolor Crónico/terapia , Costos de la Atención en Salud , Manipulaciones Musculoesqueléticas/economía , Manipulaciones Musculoesqueléticas/métodos , Dolor de Cuello/economía , Dolor de Cuello/terapia , Adulto , Dolor Crónico/diagnóstico , Dolor Crónico/fisiopatología , Investigación sobre la Eficacia Comparativa , Análisis Costo-Beneficio , Evaluación de la Discapacidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Multicéntricos como Asunto , Manipulaciones Musculoesqueléticas/efectos adversos , Dolor de Cuello/diagnóstico , Dolor de Cuello/fisiopatología , Dimensión del Dolor , Ensayos Clínicos Controlados Aleatorios como Asunto , República de Corea , Factores de Tiempo , Resultado del Tratamiento , Adulto JovenRESUMEN
BACKGROUND: Osteoporosis is a major health concern for both men and women, and associated fractures incur substantial economic burden. While there are a multitude of studies on bone mineral density (BMD) and liver diseases, not many studies have assessed the association between liver enzyme levels and BMD in homogeneous populations. METHODS: The current study investigated the association between serum liver enzyme levels and BMD at various sites in Koreans. Out of 21,517 surveyees of the 5th Korean National Health and Nutrition Examination Survey (2010-2012), 7160 participants' data on BMD, serum liver enzymes, and full covariate data were included for cross-sectional analysis. BMD at the femoral neck, lumbar spine, entire femur, and whole body was assessed using dual energy X-ray absorptiometry (DEXA), and liver enzymes included aspartate aminotransferase (AST), alanine aminotransferase (ALT), and gamma(γ)-glutamyl transferase (GGT) levels. Differences in participant characteristics by BMD and liver enzyme levels were analyzed, and complex sample design regression analysis adjusted for multiple covariates was performed to assess the relationship between liver enzymes and BMD. RESULTS: Negative associations were seen with GGT and BMD at all sites (P ≤ 0.02), ALT with lumbar spine (P = 0.0013), and AST with lumbar BMD (P = 0.0009). In particular, GGT presented strong negative associations with BMD in postmenopausal women and elder men. CONCLUSIONS: This study demonstrates a negative relationship between liver enzyme levels and BMD, and suggests that a significant association exists between osteoporosis/decreased BMD and liver disorders.