Abstract
Background: Chronic low back pain (cLBP) is a major health problem and the most common pain condition among those 60 years of age or older in the US. Despite the development of pharmacological and nonpharmacological interventions, cLBP outcomes have not improved and disability rates continue to rise. This study aims to test auricular point acupressure (APA) as a non-invasive, nonpharmacological self-management strategy to manage cLBP and to address current shortcomings of cLBP treatment. Methods: For this prospective randomized controlled study, participants will be randomly assigned into three groups: (1) APA (active points related to cLBP), (2) Comparison Group -1 (non-active points, unrelated to cLBP), (3) Comparison Group-2 (enhanced educational control, an educational booklet on cLBP will be given and the treatment used by participants for their cLBP will be recorded). The ecological momentary assessment smartphone app will be used to collect real-time cLBP outcomes and adherence to APA practice. Treatment and nonspecific psychological placebo effects will be measured via questionnaires for all participants. This proposed trial will evaluate the APA sustained effects for cLBP at 12-month follow-up. Monthly phone follow-up will be used to collect study outcomes. Blood will be collected during study visits at baseline, post-APA treatment, and follow-up study visits at 1-, 3-, 6-, 9- and 12-months post-completion of treatment for a total of 7 assessments. Appointments will start between 9 and 11 am to control for circadian variation in cytokine levels. Discussion: This study is expected to provide vital information on the efficacy, sustainability, and underlying mechanism of APA on cLBP necessary for APA to gain acceptance from both healthcare providers and patients, which would provide a strong impetus for including APA as part of cLBP management in clinical and home settings. Trial registration: NCT03589703, Registered on May 22, 2018
Clinical and radiological evaluation of Trabecular Metal and the Smith–Robinson technique in anterior cervical fusion for degenerative disease: a prospective, randomized, controlled study with 2-year follow-up
