Table 1.
Inclusion Criteria | Exclusion Criteria |
---|---|
Age ≥ 18 years | Ongoing or <4 weeks since receiving potentially neurotoxic chemotherapy |
Life expectancy ≥3 months | Other known causes of peripheral neuropathy before chemotherapy (e.g., diabetes, cervical or lumbar radiculopathy, HIV, amyloidosis, hypothyroidism) |
ECOG Performance Status, 0–2 | Known brain or spinal metastases |
Summary status of their cancer as stable or no evidence of disease for ≥1 month | Use of another investigational pain-directed therapy within 30 days |
Peripheral pain for ≥1 month attributed to CIPN | Prior interventional actions for pain control, including celiac plexus blocks and an implanted drug delivery system (such as Medtronic Synchromed Medtronic, Inc., Fridley, MN) |
Average daily pain score ≥5 of 10 | Any form of medical “metal” device (e.g., pacemakers, defibrillators, vascular clips or stents, cardiac valve, or joint replacements) |
Prior treatment (>4 weeks) with paclitaxel or docetaxel, carboplatin, cis-platinum, oxaliplatin, vincristine, vinblastine, vinorelbine, or bortezomib | An adverse reaction to past use of a TENS unit |
Women who were pregnant, nursing, or using active contraceptive | |
Active coronary artery disease within last 6 months | |
History of seizures | |
Skin conditions preventing application of the electrodes | |
Any other medical condition at the investigator discretion felt to compromise the study’s objectives |
ECOG = Eastern Cooperative Oncology Group; HIV = human immunodeficiency virus.