Evidence map›Paper›PMID 37993030›Full record

Trial reportThe journal of pain2024

Wireless Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Chemotherapy-Induced Peripheral Neuropathy (CIPN): A Proof-of-Concept Randomized Clinical Trial.

Jennifer S Gewandter, Eva Culakova, Jenae N Davis, Umang Gada, Joseph J Guido, James D Bearden, Brain Burnette, Dhaval Shah, Gary R Morrow, Karen Mustian and 2 more

2 registry-linked trialsOpen access · bronzeAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in The journal of pain, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
3.9field-weighted citation impact, top 6% 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.

NCT04367480 nacompletednot on this map

Wireless Transcutaneous Electrical Nerve Stimulation (TENS) for Chemotherapy-Induced Peripheral Neuropathy: A Phase II Clinical Trial

TypeinterventionalSponsorUniversity of Rochester NCORP Research BaseRan2020 to 2022Enrolled151ConditionsChemotherapy-Induced Peripheral NeuropathyArmsPlacebo Administration, Questionnaire Administration, Transcutaneous Electrical Nerve Stimulation
NCT06733545 completednot on this map

Study for the Evaluation of the Degree of Skin Satisfaction of Cosmetics Creams PB-011 and PB-012 for Sensitive Skin in Oncological Patients Affected by a Palmoplantar Polyneuropathy Secondary to Chemotherapy or Chemotherapeutic Agents' Fusion to Monoclonal Antibodies (Immunocitostatics)

Typeobservational_patient_registrySponsorPROSPERA BIOTECH S.L.Ran2022 to 2024Enrolled120ConditionsQuality of Life (QOL), CIPN - Chemotherapy-Induced Peripheral Neuropathy
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 17 citations in OpenAlex.

  1. Trial
  2. Trial
  3. [Electrotherapy and sensory re-education as a treatment for chemotherapy-induced neuropathy].Revista medica del Instituto Mexicano del Seguro Social · 2026
    Trial
  4. A topical nociceutical formulation ameliorates chemotherapy-induced peripheral neuropathy: a pilot randomized clinical study.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Trial
  5. Trial
  6. Trial
  7. Trial
  8. Article
  9. Review
  10. Article
  11. Article
  12. Exploring the reliability and validity of clinically-relevant outcome measures for chemotherapy-induced peripheral neuropathy.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024
    Article
  13. Article
  14. 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

12 authors at 5 institutions in 1 country.

Jennifer S GewandterDepartment of Anesthesiology and Perioperative Medicine, University of Rochester Medical Center, Rochester, New York.
Eva CulakovaDepartment of Surgery, Supportive Care in Cancer, University of Rochester Medical Center, Rochester, New York.
Jenae N DavisDepartment of Medicine, University of Rochester Medical Center, Wilmot Cancer Institute, Rochester, New York.
Umang GadaDepartment of Surgery, Supportive Care in Cancer, University of Rochester Medical Center, Rochester, New York.
Joseph J GuidoDepartment of Surgery, Supportive Care in Cancer, University of Rochester Medical Center, Rochester, New York.
James D BeardenUpstate Carolina Consortium Community Oncology Research Program (UPSTATE), Gibbs Cancer Center and Research Institute, Spartanburg, South Carolina.
Brain BurnetteCancer Research of Wisconsin and Northern Michigan NCORP, Green Bay, Wisconsin.
Dhaval ShahHelen F. Graham Cancer Center and Research Institute, Christiana Care, Newark, Delaware.
Gary R MorrowDepartment of Surgery, Supportive Care in Cancer, University of Rochester Medical Center, Rochester, New York.
Karen MustianDepartment of Surgery, Supportive Care in Cancer, University of Rochester Medical Center, Rochester, New York.
Kathleen A SlukaDepartment of Physical Therapy & Rehabilitation Sciences, University of Iowa, Iowa City, Iowa.
Nimish MohileDepartment of Neurology, University of Rochester Medical Center, Rochester, New York.
University of Rochester Medical Center · USChristiana Care Health System · USUniversity of Iowa · USUniversity of South Carolina Upstate · USUniversity of Wisconsin–Green Bay · US

Funding

URCC NCORP Research BaseUG1CA189961 · NCI · UNIVERSITY OF ROCHESTER · PI Michelle C Janelsins, KAREN M. MUSTIAN · 2014 to 2026
$67.7M
Wireless transcutaneous electrical stimulation (TENS) for chemotherapy-induced peripheral neuropathy: A phase II randomized clinical trialR21CA235389 · NCI · UNIVERSITY OF ROCHESTER · PI GEWANDTER, JENNIFER · 2019 to 2020
$363k
NCI NIH HHS R21 CA235389NCI NIH HHS UG1 CA189961
6 · The paper itself

Abstract

Chemotherapy-induced peripheral neuropathy (CIPN) affects approximately 30 to 60% of people who receive neurotoxic chemotherapy. CIPN is associated with impaired quality of life and function and has few effective treatments. This 6-site, subject and assessor-blinded randomized clinical trial (RCT) was designed to assess 1) preliminary efficacy (ie, alpha pre-specified at .2) of a wearable, app-controlled, transcutaneous electrical nerve stimulation (TENS) device for chronic CIPN and 2) feasibility of conducting a confirmatory trial within the National Cancer Institute Community Oncology Research Program (NCORP) (NCT04367480). The primary outcome was the EORTC-CIPN20. The main secondary outcomes were individual symptoms assessed daily (via 0-10 numeric rating scales). The primary analysis was an analysis of covariance (outcome: EORTC-CIPN20, fixed effect: arm, covariates: baseline EORTC-CIPN20 and site). Secondary analyses used a similar analysis of covariance models (excluding site) for each symptom on subgroups of subjects with ≥4 out of 10 for that symptom at baseline. 142 eligible subjects were randomized and received a device; 130 (91%) completed the study. The difference between groups in the EORCT-CIPN20 at the endpoint (placebo-active) was 1.05 (95% Confidence Interval: -.56, 2.67; P = .199). The difference between groups for the individual symptoms was as follows: hot/burning pain: 1.37 (-.33, 3.08; P = .112), sharp/shooting pain: 1.21 (-.37, 2.79; P = .128), cramping: 1.35 (-.32, 3.02; P = .110), tingling: .23 (-.61, 1.08; P = .587), numbness: .27 (-.51, 1.05; P = .492). An RCT of an app-controlled TENS device for chronic CIPN with excellent retention is feasible in the NCORP. Preliminary efficacy evidence suggests that TENS is promising for pain and cramping from CIPN. A confirmatory RCT of TENS for painful CIPN is highly warranted. PERSPECTIVE: Daily, home-based TENS therapy demonstrates promising efficacy for painful CIPN symptoms in this proof-of-concept randomized clinical trial. Future confirmatory trial is warranted.

Indexed as

Antineoplastic AgentsPeripheral Nervous System DiseasesProof of Concept StudyTranscutaneous Electric Nerve StimulationAdultAgedFeasibility StudiesFemaleHumansMaleMiddle AgedWearable Electronic DevicesAntineoplastic AgentsChemotherapy-induced peripheral neuropathyRandomized clinical trialTranscutaneous electrical nerve stimulation

Identifiers

PMID37993030
PMCPMC11058028
OpenAlexW4388871695

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.