Wireless transcutaneous electrical nerve stimulation device for chemotherapy-induced peripheral neuropathy: an open-label feasibility study

Abstract

Chemotherapy-induced peripheral neuropathy (CIPN) occurs in approximately 68% of patients who receive neurotoxic chemotherapy and lasts at least 6 months post-chemotherapy in approximately 30% of individuals. CIPN is associated with decreased quality of life and functional impairments. Evidence suggests that CIPN symptoms are caused, in part, by enhanced excitability and impaired inhibition in the central nervous system. Transcutaneous electrical nerve stimulation (TENS) decreases pain by counteracting both of these mechanisms and is efficacious in other conditions associated with neuropathic pain. This single-arm study (n = 29) assessed the feasibility of investigating TENS for CIPN after chemotherapy completion using a wireless, home-based TENS device. Eighty-one percent of eligible patients who were approached enrolled, and 85% of participants who received the TENS device completed the primary (6-week) study term. Qualitative interview data suggest that use of the device on the continuous setting that automatically alternates between 1-h stimulation and rest periods for 5 h/day would be acceptable to most participants. Significant (i.e., p < 0.05) improvements were observed with the EORTC-CIPN20 (percent change from baseline: 13%), SF-MPQ-2 (52%), numeric rating scale of pain (38%), tingling (30%), numbness (20%), and cramping (53%), and UENS large fiber sensation subscore (48%). Preliminary data that support the reliability and construct validity of the UENS for CIPN in cancer survivors are also provided. Together these data suggest that it is feasible to evaluate TENS for CIPN using a wireless, home-based device and that further evaluation of TENS for CIPN in a randomized clinical trial is warranted.

Keywords: Cancer survivors; Chemotherapy-induced peripheral neuropathy; Feasibility trial; Transcutaneous electrical nerve stimulation.

Conflict of interest statement

6. Conflicts of interest

Neurometrix provided the devices and electrodes for this investigator-initiated study and funds to support the conduct of the trial. The authors had complete control over the development of the protocol, conduct of the study, and publication of the results. Neurometrix was provided a copy of the manuscript prior to submission for publication, but did not provide any input on the manuscript.

Figures

Figure 1.

(A) Conceptual framework and (B) Study schema

Figure 2.

CONSORT diagram of participant disposition

Figure 3.

Preliminary efficacy based on patient-reported outcome and physical exam measures. (A) The large fiber sensation sub-score of the UENS is comprised of the vibration and joint position exam items. The diary scores are the mean of the baseline and 6-week diary entries. (B) The baseline sensation threshold from the monofilament test is represented by the circle. The endpoint sensation threshold is represented by the arrow head. In the case where there is only a circle, the sensation threshold was the same at the baseline and endpoint visits. IQR interquartile range.