Self-administered acupressure for veterans with chronic back pain: Study design and methodology of a type 1 hybrid effectiveness implementation randomized controlled trial.

Autor: Murphy SL; Department of Physical Medicine and Rehabilitation, University of Michigan, Ann Arbor, MI, USA; Department of Internal Medicine, Division of Rheumatology, University of Michigan, Ann Arbor, MI, USA., Zick SM; Department of Family Medicine, University of Michigan, Ann Arbor, MI, USA; Department of Nutritional Sciences, School of Public Health, University of Michigan, Ann Arbor, MI, ISA, USA. Electronic address: szick@umich.edu., Harris RE; Department of Anesthesiology, University of Michigan, Ann Arbor, MI, USA; Susan Samueli Integrative Health Institute, School of Medicine, University of California at Irvine, Irvine, CA, USA. Electronic address: richareh@hs.uci.edu., Smith SN; Department of Health Management and Policy, School of Public Health, University of Michigan, Ann Arbor, MI, USA. Electronic address: shawnana@med.umich.edu., Sen A; Department of Family Medicine, University of Michigan, Ann Arbor, MI, USA. Electronic address: anandas@med.umich.edu., Alexander NB; Department of Internal Medicine, Division of Geriatric Medicine, University of Michigan, Ann Arbor, MI, USA; VA Ann Arbor Healthcare System, Geriatric Research Education Clinical Center, Ann Arbor, MI, USA. Electronic address: nalexand@med.umich.edu., Caldararo J; VA Ann Arbor Healthcare System, Center for Clinical Management Research, Ann Arbor, MI, USA. Electronic address: Jennifer.caldararo@va.gov., Roman P; VA Ann Arbor Healthcare System, Center for Clinical Management Research, Ann Arbor, MI, USA. Electronic address: patti.roman@va.gov., Firsht E; VA Ann Arbor Healthcare System, Center for Clinical Management Research, Ann Arbor, MI, USA. Electronic address: elizabeth.firsht@va.gov., Belancourt P; VA Ann Arbor Healthcare System, Center for Clinical Management Research, Ann Arbor, MI, USA. Electronic address: patrick.belancourt@va.gov., Maciasz R; VA Ann Arbor Healthcare System, Department of Ambulatory Care, Ann Arbor, MI, USA; Department of Internal Medicine, Division of General Medicine, University of Michigan, Ann Arbor, MI, USA. Electronic address: Rachael.Maciasz@va.gov., Perzhinsky J; VA Ann Arbor Healthcare System, Department of Ambulatory Care, Ann Arbor, MI, USA. Electronic address: Juliette.Perzhinsky@va.gov., Mitchinson A; VA Ann Arbor Healthcare System, Center for Clinical Management Research, Ann Arbor, MI, USA. Electronic address: allison.mitchinson@va.gov., Krein SL; VA Ann Arbor Healthcare System, Center for Clinical Management Research, Ann Arbor, MI, USA; Department of Internal Medicine, Division of General Medicine, University of Michigan, Ann Arbor, MI, USA. Electronic address: skrein@med.umich.edu.
Jazyk: angličtina
Zdroj: Contemporary clinical trials [Contemp Clin Trials] 2023 Jul; Vol. 130, pp. 107232. Date of Electronic Publication: 2023 May 18.
DOI: 10.1016/j.cct.2023.107232
Abstrakt: Background: Chronic low back pain is prevalent and disabling in Veterans, but effective pain management is challenging. Clinical practice guidelines emphasize multimodal pain management including evidence-based complementary and integrative health treatments such as acupressure as a first line of care. Unfortunately, the ability to replicate interventions, cost, resources, and limited access are implementation barriers. Self-administered acupressure has shown positive effects on pain and can be practiced anywhere with little to no side effects.
Methods/design: The aims of this Type 1 hybrid effectiveness implementation randomized controlled trial are 1) to determine effectiveness of a self-administered acupressure protocol at improving pain interference and secondary outcomes of fatigue, sleep quality, and disability in 300 Veterans with chronic low back pain, and 2) evaluate implementation barriers and facilitators to scale-up acupressure utilization within Veterans Health Administration (VHA). Participants randomized to the intervention will receive instruction on acupressure application using an app that facilitates daily practice for 6 weeks. During weeks 6 through 10, participants will discontinue acupressure to determine sustainability of effects. Participants randomized to waitlist control will continue their usual care for pain management and receive study materials at the end of the study period. Outcomes will be collected at baseline and at 6- and 10-weeks post baseline. The primary outcome is pain interference, measured by the PROMIS pain interference scale. Using established frameworks and a mixed methods approach, we will evaluate intervention implementation.
Discussion: If acupressure is effective, we will tailor strategies to support implementation in the VHA based on study findings.
Trial Registration Number: NCT05423145.
Competing Interests: Declaration of Competing Interest The authors declare that they have no competing interests to disclose.
(Published by Elsevier Inc.)
Databáze: MEDLINE