New Pain Device May Reduce Chemo-Induced Pain Scores by 30%
Study evaluates cancer patients
According to a new study published in the Journal of Pain and Palliative Care Pharmacotherapy, patients with chronic, chemotherapy-induced peripheral neuropathy (CIPN) experienced an average pain-score reduction of 31.8% in their level of chronic pain while undergoing treatment with the Calmare MC5A pain therapy device (Competitive Technologies).
From a pain-score perspective, the FDA requires a minimum quality-of-life improvement of 20% in order to approve a medical device.
The Calmare MC5A pain therapy device is a non-narcotic, non-invasive method for treating high-intensity oncologic, neuropathic, or drug-resistant pain through electronic nerve stimulation. During treatment, nerve fibers convey a message of “normality” to the central nervous system (CNS), which enables the CNS to modify its reflex adaptive responses to the painful stimuli.
In the new study, 39 cancer patients with pain (16 men and 23 women; mean age, 56.5 years) were treated with the Calmare MC5A device over an 18-month period for an average of 9.3 days each. The study’s primary endpoint was a significant change in the pain numerical rating scale (NRS) at 1 month. Secondary outcomes included changes in the Brief Pain Inventory (BPI) and in the European Organization for Treatment and Cancer QLC-CIPN-20 (EORTC CIPN-20) assessment over time.
The study evaluated the patients’ “now” pain scores, which were reduced from 6.6 before treatment to 4.5 (a 31.8% reduction) at 14 days and to 4.6, 4.8, and 4.6 at 1, 2, and 3 months, respectively (P < 0.001). Clinically important and statistically significant improvements were seen in average, least, and worst pain; in BPI interference-with-life scores; and in motor and sensory scales on the EORTC CIPN-20. No adverse effects were observed.