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Clinical Trials

There are several studies that have been performed to evaluate the efficacy of the treatment including a pilot study at The Massey Cancer Center where 16 patients with CIPN (chemotherapy-induced peripheral neuropathy) were treated, and 64% was the overall score reduction in pain. Fifteen of the 16 patients had a significant reduction in their pain score. These results were published in the Journal of Pain and Symptom Management.

Dr. Thomas Smith, director of Palliative Care at Johns Hopkins, recently did a pilot study for PHN patients where they achieved an amazing 95% reduction in pain a month after the treatment with no side effects. Another study recently published in the Journal of Pain and Symptom Management with 52 random pain participants compared guideline-based drug management with Scrambler and the results were amazing. The Calmare® participants had a 91% reduction in pain compared to a 28% reduction in pain for those who used drug management.

The Mayo Clinic is currently conducting three studies; one will be completed the first half of 2013. And The University of Wisconsin has just completed a double-blind study with a sham device. Those results will be published in the near future. The Massey Cancer Center just completed a phase II study with 39 patients that will be published in the near future. They achieved a 3.3 reduction in pain on a 0 to 5 scale.

Recently it was announced that the U.S. military has purchased 15 Scrambler Therapy units for several U.S. military medical facilities in the U.S. and overseas including The VA, The U.S. Army, The U.S. Air Force, and The U.S. Navy. Currently The Mayo Clinic, The Massey Cancer Center, and The University of Wisconsin are conducting studies using the Calmare® device.

Clinical Trials

 

  • Trial of Scrambler Therapy or Sham Treatment for Low Back Pain NCT ID: NCT01896687
    Sponsor: Virginia Commonwealth University, School of Nursing
    Principal Investigator: Angela Starkweather
    Protocol IDs: SCRA-LBP
  • Scrambler Therapy in Treating Chronic Pain in Patients With Rash From Varicella Zoster Virus Infection NCT ID: NCT01347736
    Sponsor: Mayo Clinic
    Principal Investigator: Charles L. Loprinzi
    Protocol IDs: MC10CE, NCI-2011-00338
  • Scrambler Therapy in Treating Pain and Peripheral Neuropathy in Patients Previously Treated With Chemotherapy NCT ID: NCT01347723
    Sponsor: Mayo Clinic
    Principal Investigator: Charles L. Loprinzi
    Protocol IDs: MC10CC, NCI-2011-00339
  • MC5-A Scrambler Therapy in Reducing Peripheral Neuropathy Caused by Chemotherapy NCT ID: NCT01290224
    Sponsor: Mayo Clinic
    Principal Investigator: Charles L. Loprinzi
    Protocol IDs: MC10C8, NCI-2011-00109, 10-007874
  • MC-5A for Chemotherapy Induced Peripheral Neuropathy NCT ID: NCT01261780
    Sponsor: University of Wisconsin, Madison
    Principal Investigator: Toby Campbell
    Protocol IDs: OS10328
  • Electrical Stimulation Pain Therapy in Treating Chronic Pain and Numbness Caused By Chemotherapy in Patients With Cancer NCT ID: NCT01196442
    Sponsor: Virginia Commonwealth University, Massey Cancer Center
    Principal Investigator: Thomas J. Smith
    Protocol IDs: MCC-13098, NCI-2010-01945
  • Res Nurs Health. 2015 Jan 8. doi: 10.1002/nur.21632.
    Decreased Low Back Pain Intensity and Differential Gene Expression Following Calmare®: Results From a Double-Blinded Randomized Sham-Controlled Study.
    Starkweather AR1, Coyne P, Lyon DE, Elswick RK Jr, An K, Sturgill J.
    Author information
    1Associate Professor and Chair Department of Adult Health and Nursing Systems, Virginia Commonwealth University School of Nursing, 1100 East Leigh Street, P.O. Box 980567, Richmond, VA 23298-0567.
    Abstract 
    In this double-blinded, randomized controlled trial we evaluated the effects of Calmare®, a non-invasive neurocutaneous electrical pain intervention, on lower back pain intensity as measured by the “worst” pain score and on pain interference using the Brief Pain Inventory-Short Form, on measures of pain sensitivity assessed by quantitative sensory testing, and on mRNA expression of pain sensitivity genes. Thirty participants were randomized to receive up to 10 sessions of Calmare® treatment (n?=?15) or a sham treatment (n?=?15) using the same device at a non-therapeutic threshold. At 3 weeks after conclusion of treatment, compared with the sham group, the Calmare® group reported a significant decrease in the “worst” pain and interference scores. There were also significant differences in pain sensitivity and differential mRNA expression of 17 pain genes, suggesting that Calmare® can be effective in reducing pain intensity and interference in individuals with persistent low back pain by altering the mechanisms of enhanced pain sensitivity. Further study of long-term pain outcomes, particularly functional status, analgesic use and health care utilization, is warranted. © 2015 Wiley Periodicals, Inc.
    © 2015 Wiley Periodicals, Inc.
    KEYWORDS:
    Calmare®; chronic pain; gene expression; low back pain; scrambler
    PMID: 25572279 [PubMed – as supplied by publisher] Decreased Low Back Pain Intensity and Differential Gene Expression … – PubMed – NCBI

    Decreased low back pain intensity and differential gene expression following calmare: results from a double-blinded randomized sham-controlled study
    Research in Nursing & Health, 01/13/2015 Clinical Article
    Starkweather AR, et al. – In this double–blinded, randomized controlled trial the authors aimed to evaluate the effects of Calmare®, a non–invasive neurocutaneous electrical pain intervention, on lower back pain intensity as measured by the “worst” pain score and on pain interference using the Brief Pain Inventory–Short Form, on measures of pain sensitivity assessed by quantitative sensory testing, and on mRNA expression of pain sensitivity genes.

    Methods 
    Thirty participants were randomized to receive up to 10 sessions of Calmare® treatment (n=15) or a sham treatment (n=15) using the same device at a non-therapeutic threshold.

    Results 
    At 3 weeks after conclusion of treatment, compared with the sham group, the Calmare® group reported a significant decrease in the “worst” pain and interference scores.
    There were also significant differences in pain sensitivity and differential mRNA expression of 17 pain genes, suggesting that Calmare® can be effective in reducing pain intensity and interference in individuals with persistent low back pain by altering the mechanisms of enhanced pain sensitivity.

 

Calmare Case Studies

Pilot evaluation of Scrambler therapy for the treatment of chemotherapy-induced peripheral neuropathy–Deirdre R. Pachman & Breanna L. Weisbrod & Drew K. Seisler & Debra L. Barton & Kelliann C. Fee-Schroeder & Thomas J. Smith & Daniel H. Lachance & Heshan Liu & Randy A. Shelerud & Andrea L. Cheville & Charles L. Loprinzi

Noninvasive Treatments for Pediatric Complex Regional Pain Syndrome: A Focused Review–Benjamin R. Katholi, MD, Suzanne S. Daghstani, MS, OTR/L, Gerard A. Banez, PhD, Kimberly K. Brady, MSI

Artificial Neurons in Oncological Pain –G. Marineoa, S. Spazianib, A.F. Sabatoc, F. Marottaa

Untreatable Pain Resulting from Abdominal Cancer:New Hope from Biophysics?–Giuseppe Marineo

Scrambler Therapy–A.F. Sabato, G. Marineo, A. Gatti

Safety and Efficacy of Scrambler Therapy for Cancer Pain–M. Ricci, S. Pirotti, M. Burgio, E. Scarpi, E. Sansoni, R. Ridolfi, D. Amadori, M. Maltoni

Pilot Trial of a Patient-Specific Cutaneous Electrostimulation Device (MC5-A Calmare) for Chemotherapy-Induced Peripheral Neuropathy–T. J. Smith, MD, P. J. Coyne, RN, MSN, G. L. Parker, RN, MSN, P. Dodson, BSN, MA, and V. Ramakrishnan, PhD

The Use of “Scrambler Therapy” for Failed Back Surgery Syndrome–S. Abdi, MD, PhD, V M Lakkimsetty MD, J. Barrera, MD, K. Candiotti, MD, D. Lubarsky, MD

Managing Chronic Pain: Results From An Open-label Study using MC5-A Calmare® Device–M. Ricci, S. Pirotti, E. Scarpi, M. Burgio, M. Maltoni, E. Sansoni, D. Amadori

Pilot Study of Scrambler Therapy for the Treatment of Chemotherapy-induced Peripheral Neuropathy–D. R. Pachman, B. M. Linquist, D. L. Barton, K. C. Fee-Schroeder, T. J. Smith, D. H. Lachance, H. Liu, D. K. Seisler, C. L. Loprinzi

Treatment of Post-herpetic Pain with Scrambler Therapy, a Patient-specific Neuro-cutaneous Electrical Stimulation Device–T. J. Smith, G. Marineo

Scrambler Therapy for Patients with Cancer Pain–Park HS, MD, Sin WK, MD, Kim HY, MD, Moon JY, MD, Park SY, MD, Kim YC, MD, Lee SC, MD

Scrambler Therapy: An Innovative and Effective Treatment for Chronic Neuropathic Pain–F. Sparadeo, Ph.D., C. Kaufman, RN, BScN, CLCp, CNLCP, S. D ‘Amato, M.D.

Scrambler Therapy May Relieve Chronic Neuropathic Pain More Effectively Than Guideline-Based Drug Management: Results of a Pilot, Randomized, Controlled Trial–G. Marineo, PhD, V. Iorno, MD, C. Gandini, MD, V. Moschini, MD, T. J. Smith, MD

Clinical Experiences on the Effect of Scrambler Therapy for Patients with Postherpetic Neuralgia–Ko YK, MD, Lee HY, MD, Lee WY, MD

 

 

Written by Calmare Pain Relief Solutions August 21, 2013