Efficacy and safety of auricular acupressure for chemotherapy-induced peripheral neuropathy among patients with breast cancer: a study protocol for a randomized controlled trial

Abstract

Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a frequently-reported distress symptom in breast carcinoma patients under chemotherapy. Although previous studies emphasized lack of ideal neuroprotective or therapeutic agents for CIPN, there are no strongly recommended treatments. Nevertheless, auricular acupressure (AA) is a novel remedy for controlling symptoms in many healthcare settings. However, therapeutic effects of AA among patients with CIPN have not yet been elucidated fully. Therefore, we designed a trial to examine the effectiveness and safety of AA in breast cancer patients. Methods: This randomized, double-blind, sham-controlled trial will assess 120 breast cancer survivors. After enrollment, the participants will be stratified depending on administration of medications prescribed for CIPN treatment, and then assigned randomly to the experimental or control groups in an allocation ratio of 1:1. For experimental groups, AA will be applied on four points, namely, shemen, liver, spleen, and finger/ toe, while for the control groups, sham AA will be exerted on other four points that are remote from the treatment points and unrelated to neuropathic symptoms. All participants will undergo the same acupressure procedure, for two minutes each time, thrice daily for 3 weeks, and CIPN symptoms and health-related quality of life will be assessed by a blinded research assistant and a physician before, during, immediately after, and 4 weeks after AA. Occurrence, type, and severity of safety issues will be routinely monitored to confirm the non-toxic nature of AA. Repeated measures analysis of variance will be used to examine the changing pattern of CIPN symptoms and based on sensitivity analysis. Discussion: It is expected that the rationale and design of this protocol will offer knowledge regarding a standardized process to guide current and future studies and accumulates clinical experiences in applying non-pharmacological intervention. The present trial is the first to examine the therapeutic effects of AA in breast cancer patients with CIPN. The findings of the study may provide convincing evidence regarding the effectiveness of CIPN symptoms.

The Effects of Auricular Acupressure on Low Back Pain, Neuropathy and Sleep in Patients with Persistent Spinal Pain Syndrome (PSPS): A Single-Blind, Randomized Placebo-Controlled Trial

“…The AA intervention was provided for 6 weeks with 5 days of seed attachment and 2 days of rest as 1 cycle. The reflex points of the experimental group were shenmen, subcortex, sympathetic nerves, liver, and lumbar vertebrae, whereas using helix 1~5 points, which was the zone not corresponding to pain, neuropathy, and sleep and away from the reflex points of the experimental group, for the control group (Figure 2) [12,14]. The suitability of these points was consulted with two experts before the final selection.…”

“…Auricular acupressure (AA) is an economical, simple, and non-invasive intervention that does not have the risk of cross-infection or side effects; thus, it is considered a nursing intervention that can be performed independently by nurses instead of acupuncture for patients who have undergone spinal surgery [12]. In addition to pain, AA has been proven effective in sleep disorders [13] and neuropathy [14].…”

Non-pharmacological therapy for chemotherapy-induced peripheral neurotoxicity: a network meta-analysis of randomized controlled trials

“…Fourteen studies applied other scales for assessment [14,21,27,34,[42][43][44][45][46][47][48][49][50][51], involving 857 participants. One four-arm trial [43] conducted direct a comparison among Acu, hydroelectric baths (HEB), vitamin, and UCP, one study used ES, one three-arm study conducted a direct comparison among SMT, RT, and UCP [44], five studies used massage [27,42,45,46,51], four study used ME [34,47,48,50], and one study used PBM [21]. A close loop of the network map was formed by SMT, RT, and UCP.…”

“…Fifteen studies [14, 16, 18-20, 22, 26, 37, 44, 46, 49, 51, 57-59] reported sensory symptoms, involving 991 participants. Among the studies, two studies used interventions pooled as ES [14,16], 13 studies used UCP, two applied ME [37,57], four used studies pooled as massage [19,46,51,58], 3 applied Edu [20,22,59]. One three-arm trial conducted a direct comparison among SMT, RT, and UCP [44], and one study applied ET [37].…”

“…Fourteen studies [14, 16, 18-20, 22, 27, 37, 44, 46, 51, 57-59] reported motor symptoms, involving 970 participants. Among these studies, two applied ES [14,16], two used interventions pooled as ME [37,57], one conducted a direct comparison between ME and ET [37], four used massage [19,46,51,58], three used interventions pooled as Edu [20,22,59], one three-arm trial [44] conducted a direct comparison among SMT, RT, and UCP, one study used Yoga, one study used PBM, and one used MIWalk. There was no direct comparison of MIWalk and ET with controls.…”