TY - JOUR
T1 - A prospective randomized controlled study of auricular point acupressure to manage chronic low back pain in older adults
T2 - Study protocol
AU - Yeh, Chao Hsing
AU - Li, Cuicui
AU - Glick, Ronald
AU - Schlenk, Elizabeth A.
AU - Albers, Kathryn
AU - Suen, Lorna Kwai Ping
AU - Lukkahatai, Nada
AU - Salen, Nicole
AU - Pandiri, Sonaali
AU - Ma, Weixia
AU - Perrin, Nancy
AU - Morone, Natalia E.
AU - Christo, Paul J.
N1 - Funding Information:
Research reported in this publication was supported by the National Institute on Aging of the National Institutes of Health under Award Number R01AG056587. The study funder has no role in the study design, data collection and management, and manuscript writing publication.
Publisher Copyright:
© 2020 The Author(s).
PY - 2020/1/20
Y1 - 2020/1/20
N2 - Background: 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. 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/design: For 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. 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.
AB - Background: 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. 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/design: For 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. 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.
KW - Auricular point acupressure
KW - Chronic low back pain
KW - Cytokines
KW - Older adults
UR - http://www.scopus.com/inward/record.url?scp=85078448767&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85078448767&partnerID=8YFLogxK
U2 - 10.1186/s13063-019-4016-x
DO - 10.1186/s13063-019-4016-x
M3 - Article
C2 - 31959226
AN - SCOPUS:85078448767
SN - 1745-6215
VL - 21
JO - Trials
JF - Trials
IS - 1
M1 - 99
ER -