Abstract
BackgroundChronic low back pain (cLBP) is a major health problem and the most common pain condition among those aged 60 years 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/designFor this prospective randomized controlled study, participants will be randomly assigned to three groups: (1) APA group (active points related to cLBP), (2) Comparison group-1 (non-active points, unrelated to cLBP), and (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 telephone 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 seven assessments. Appointments will start between 9 and 11 am to control for circadian variation in cytokine levels.DiscussionThis 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 registrationClinicalTrials.gov, ID: NCT03589703. Registered on 22 May 2018.
Highlights
Chronic low back pain is a major health problem and the most common pain condition among those aged 60 years or older in the United States (US)
This study is expected to provide vital information on the efficacy, sustainability, and underlying mechanism of auricular point acupressure (APA) on Chronic low back pain (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
This explosive increase in opioid use for chronic pain comes with significant risk, including misuse, overdose, and addiction [8], and brings adverse side effects such as constipation, nausea, and somnolence [9,10,11], opioid-induced hyperalgesia [12, 13], and cognitive dysfunction [14, 15], Non-opioid pharmacotherapy is associated with a variety of adverse side effects, such as drowsiness, constipation, dry mouth, gastrointestinal bleeding, liver and kidney toxicity, and addiction [16, 17]
Summary
Chronic low back pain (cLBP) is a major health problem and the most common pain condition among those aged 60 years or older in the US. Associated healthcare expenditure for cLBP is over US$253 billion annually, owing to medical care and disability-related productivity loss and wages [3] Compared to those in middle-age, older adults have a higher prevalence of cLBP, with longer symptom duration, greater associated disability and depression [1, 4], and multiple medical conditions that require multiple medications. Older adults account for a five-time increase in hospitalizations for opioid abuse [7] This explosive increase in opioid use for chronic pain comes with significant risk, including misuse, overdose, and addiction [8], and brings adverse side effects such as constipation, nausea, and somnolence [9,10,11], opioid-induced hyperalgesia [12, 13], and cognitive dysfunction [14, 15], Non-opioid pharmacotherapy is associated with a variety of adverse side effects, such as drowsiness, constipation, dry mouth, gastrointestinal bleeding, liver and kidney toxicity, and addiction [16, 17]. Additional scalable, safe pain management approaches must be developed to provide patients with reliable, low-cost pain relief without new side effects, prolonged treatment, or frequent visits to healthcare providers
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