Results May Potentially Surpass the FDA's 20% Quality of Life Threshold Required for Product Approval and Streamlined Treatment Reimbursement
Fairfield, CT -- (SBWIRE) -- 03/27/2014 -- The results of a recently published, single-arm clinical study in the Journal of Pain and Palliative Care Pharmacotherapy, (December 2013) demonstrated how a cohort of 39 chronic, chemotherapy- induced peripheral neuropathy (CIPN) patients experienced an average pain score reduction of 31.8% in their level of chronic pain undergoing Calmare® Pain Device therapy – Competitive Technologies, Inc., (CTI) flagship medical product.
Chemotherapy-induced peripheral neuropathy (CIPN) is damage done to the peripheral nervous system. Typical symptoms include numbness, tingling, or burning sensations that often begin in the fingertips or toes, and often progresses. Patients may notice things that were previously not painful, now cause pain, such as touching hot or cold items, and develop various degrees of weaknesses throughout their bodies. Several chemotherapeutics may cause immediate reaction after the first dose while others have a delayed onset of symptoms. From a pain score perspective, the U.S Food & Drug Administration (FDA), requires a minimum quality-of-life improvement of 20% in order to attain medical device approval.
"The study's results are consistent with the typical Calmare treatment protocol," commented Patrick J. Coyne, MSN, ACHPN, ACNS-BC, FAAN, Clinical Director, Pain and Palliative Care at the Thomas Palliative Care Services at Virginia Commonwealth University. "While the study was a single arm study, the results were statistically significant and draws attention to the fact that Calmare therapy may provide significant chronic pain relief and marked improvement in a cancer patient's quality of life."
According to Competitive Technologies CEO Conrad Mir, "The pain relief obtained in this study supports our effort to further develop and fully understand the technology surrounding Calmare therapy. We are committed to Calmare and its potential for addressing pain."
About the Study
Title: "A Trial of Scrambler Therapy in the Treatment of Cancer Pain Syndromes and Chronic Chemotherapy-Induced Peripheral Neuropathy.
Premise: Chronic chemotherapeutic-derived pain condition may be treated with the Calmare® Pain Therapy Device, a non-narcotic, non-invasive medical procedure for the treatment of chronic pain. The study used Calmare, which is a patient-specific electrocutaneous nerve stimulation device (Calmare MC5A device), to treat 39 cancer patients with pain. The cohort was comprised of 16 men and 23 women with a mean age 56.5 years of age were treated over an 18-month period for an average of 9.3 days each.
Treatment: Patients in the single-arm trial received Calmare therapy for 10 sessions (one daily) over a two-week period. The primary outcome was a significant change in pain numerical rating scale (NRS) at one month; secondary outcomes were changes in the Brief Pain Inventory and European Organization for Treatment and Cancer QLC-CIPN-20 (EORTC CIPN-20), over time.
Results: The study gauged the "now" pain scores which were reduced from 6.6 before treatment to 4.5 or a 31.8% reduction at 14 days, 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; BPI interference with life scores; and motor and sensory scales on the EORTC CIPN-20. No adverse effects were observed.
Conclusion: "Calmare therapy appeared to relieve cancer-associated chronic neuropathic pain both acutely and chronically, and provided sustained improvements in many indicators of quality of life."
Authors: Patrick J. Coyne, MSN, ACHPN, ACNS-BC, FAAN, Clinical Director, Pain and Palliative Care, Thomas Palliative Care Services, Virginia Commonwealth University, Massey Cancer Center, Richmond, VA, USA., Wen Wan, PhD – assistant professor of the Department of Biostatistics at Virginia Commonwealth University, Richmond, VA, USA; Patricia Wagner Dodson, RN, MA – Research Nurse at the Massey Cancer Center, Virginia Commonwealth University, Richmond, VA, USA; Craig Swainey, MD – assistant professor of Hematology Oncology and Palliative Care at the Virginia Commonwealth University, Massey Cancer Center, and Richmond, VA, USA; and Thomas J. Smith, MD, FACP, FASCO, FAAHPM – director of Palliative Care for Johns Hopkins Medical Institutions, Baltimore, MD, USA.
About Competitive Technologies Inc
Competitive Technologies Inc., the pain mitigation company, develops and commercializes innovative pain management products and technologies. CTI is the licensed distributor of the non-invasive, Calmare® pain therapy medical device, which incorporates a novel biophysical approach developed to treat neuropathic and cancer-derived pain
Certain statements contained in this press release are forward-looking statements that involve risks and uncertainties. The statements contained herein that are not purely historical are forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements deal with the Company’s current plans, intentions, beliefs and expectations and statements of future economic performance. Forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results in future periods to differ materially from what is currently anticipated. Factors that could cause or contribute to such differences include those discussed from time to time in reports filed by the Company with the Securities and Exchange Commission. The Company cannot guarantee its future results, levels of activity, performance or achievements.