A Randomized Controlled Study of Auricular Point Acupressure to Manage Chemotherapy-Induced Neuropathy: Study Protocol

Authors

Nada Lukkahatai
Michael V Nguyen
Jingyu Zhang
Yu-Min Cho
Chitchanok Benjasirisan
Heijingzi Monica Jia
Claudia M Campbell
Jennifer Kawi
Hulin Wu
Hongyu Wang
Rupsikha Bora
Johannes Thrul
Constance M Johnson
Thomas J Smith

Publication Date

1-1-2024

Journal

PLoS One

Abstract

Objective: Chemotherapy-induced neuropathy (CIN) significantly impacts cancer patients, leading to functional disability, diminished quality of life, and increased healthcare costs amid the ongoing opioid crisis. Auricular point acupressure (APA), a non-invasive and non-pharmacological alternative, has shown potential for alleviating the pain, numbness, and tingling associated with CIN. This study aims to assess the efficacy of APA for CIN symptoms and physical function and to examine the mechanisms underlying APA's effects on CIN.

Methods: This is a three-arm randomized controlled clinical trial protocol. Patients aged 18 and older who are experiencing CIN are randomly assigned to one of the three groups: an APA group (in-person APA; mAPA), a sham control group (virtual APA; vAPA), and a wait-list usual care control group (UC). During the four-week program, participants in the mAPA receive an in-person APA treatment and training; the sham control participants (vAPA) receive a self-guided smartphone APA application with APA demonstration videos; and the UC participants will continue with the usual care and be re-randomized into one of the APA groups. The primary outcomes are changes in CIN symptoms and physical function. Secondary outcomes include evaluating pain sensory thresholds, motor and cognitive functioning, inflammatory signaling, brain connectivity, opioid use, and quality of life. The outcomes are measured at baseline, program completion (4 weeks), and at monthly follow-up for 3 months post-intervention.

Discussion: This study will provide evidence supporting the potential viability of APA as an intervention for CIN.

Trial registration: ClinicalTrials.gov, ID NCT04920097 registered on 3 June 2021.

Keywords

Adult, Female, Humans, Male, Middle Aged, Acupressure, Antineoplastic Agents, Neoplasms, Peripheral Nervous System Diseases, Quality of Life, Randomized Controlled Trials as Topic

DOI

10.1371/journal.pone.0311135

PMID

39325795

PMCID

PMC11426428

PubMedCentral® Posted Date

9-26-2024

PubMedCentral® Full Text Version

Post-print

Published Open-Access

yes