Evidence map›Paper›PMID 20813492›Full record

Trial reportJournal of pain and symptom management2010

Pilot trial of a patient-specific cutaneous electrostimulation device (MC5-A Calmare®) for chemotherapy-induced peripheral neuropathy.

Thomas J Smith, Patrick J Coyne, Gwendolyn L Parker, Patricia Dodson, Viswanathan Ramakrishnan

Registry-linked trialAbstract readClinical Trial
In one paragraph

Trial report in Journal of pain and symptom management, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03707444 (A Pilot Trial of Scrambler Therapy for Pain Associated With Pancreas Cancer), which is not on this map. Cited by 47 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 2 pooled it
2.7field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03707444 withdrawnnot on this mapstarted 2018, after this paper: background citation

A Pilot Trial of Scrambler Therapy for Pain Associated With Pancreas Cancer

TypeobservationalSponsorSidney Kimmel Comprehensive Cancer Center at Johns HopkinsRan2018 to 2019Enrolled0ConditionsCancer Pancreas, Pain Syndrome, Cancer Related PainArmsScrambler Therapy Device
3 · Its place in the literature

Who cites it

47 citing papers in PubMed, 2 syntheses or guidelines pooled it, 103 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Scrambler therapy for treatment of poststroke pain.Annals of clinical and translational neurology · 2024
    Trial
  4. Trial
  5. Trial
  6. Scrambler therapy for chemotherapy neuropathy: a randomized phase II pilot trial.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2020
    Trial
  7. Wireless transcutaneous electrical nerve stimulation device for chemotherapy-induced peripheral neuropathy: an open-label feasibility study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2019
    Trial
  8. Trial
  9. Evaluation of the treatment of chronic chemotherapy-induced peripheral neuropathy using long-wave diathermy and interferential currents: a randomized controlled trial.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2016
    Trial
  10. Pilot evaluation of Scrambler therapy for the treatment of chemotherapy-induced peripheral neuropathy.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2015
    Trial
  11. Trial
  12. Trial
  13. Review
  14. Article
  15. Review
  16. Review
  17. Review
  18. Treatment and diagnosis of chemotherapy-induced peripheral neuropathy: An update.Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie · 2022
    Review
  19. Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 1 institution in 1 country.

Thomas J SmithMassey Cancer Center, Virginia Commonwealth University, Richmond, Virginia, USA. tsmith5@mcvh-vcu.edu
Patrick J Coyne
Gwendolyn L Parker
Patricia Dodson
Viswanathan Ramakrishnan
Virginia Commonwealth University · US

Funding

Translational Research Central ServicesP30CA006973 · NCI · JOHNS HOPKINS UNIVERSITY · PI WILLIAM George NELSON · 1985 to 2026
$208.6M
Virus Vector Shared ResourceP30CA016059 · NCI · VIRGINIA COMMONWEALTH UNIVERSITY · PI Kim Felder Rhoads · 1985 to 2026
$51.0M
Palliative Care for Hospitalized Cancer PatientsR01CA116227 · NCI · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI MEIER, DIANE E · 2006 to 2010
$6.6M
NCI NIH HHS 5 P30 CA16059NCI NIH HHS P30 CA006973NCI NIH HHS P30 CA016059NCI NIH HHS R01 CA116227NCI NIH HHS R01CA116227-01NLM NIH HHS G08 LM0095259
6 · The paper itself

Abstract

contextChemotherapy-induced peripheral neuropathy (CIPN) is a major dose-limiting and persistent consequence of numerous classes of antineoplastic agents, affecting up to 30%-40% of patients. To date, there is no effective prevention or therapy. An evolving hypothesis for reducing CIPN pain involves direct nerve stimulation to reduce the pain impulse.

objectivesTo evaluate the impact on CIPN associated with the MC5-A Calmare® therapy device.

methodsThe MC5-A Calmare® therapy device is designed to generate a patient-specific cutaneous electrostimulation to reduce the abnormal pain intensity. Sixteen patients from one center received one-hour interventions daily over 10 working days.

resultsOf 18 patients, 16 were evaluable. The mean age of the patients was 58.6 years-four men and 14 women-and the duration of CIPN was three months to eight years. The most common drugs were taxanes, platinums, and bortezomib (Velcade, Millenium Pharmaceuticals, Cambridge MA). At the end of the study (Day 10), a 20% reduction in numeric pain scores was achieved in 15 of 16 patients. The pain score fell 59% from 5.81±1.11 before treatment to 2.38±1.82 at the end of 10 days (P<0.0001 by paired t-test). A daily treatment benefit was seen with a strong statistically significant difference between the pre- and post-daily pain scores (P<0.001). Four patients had their CIPN reduced to zero. A repeated-measures analysis using the scores from all 10 days confirmed these results. No toxicity was seen. Some responses have been durable without maintenance.

conclusionPatient-specific cutaneous electrostimulation with the MC5-A Calmare® device appears to dramatically reduce pain in refractory CIPN patients with no toxicity. Further studies are underway to define the benefit, mechanisms of action, and optimal schedule.

Indexed as

Transcutaneous Electric Nerve StimulationAdultAgedAntineoplastic AgentsBoronic AcidsBortezomibFemaleHumansMaleMiddle AgedPain MeasurementPeripheral Nervous System DiseasesPilot ProjectsPyrazinesTaxoidsTreatment OutcomeAntineoplastic AgentsBoronic AcidsBortezomibPyrazinesTaxoids

Identifiers

PMID20813492
PMCPMC4383258
OpenAlexW2148049464

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.