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Behavioural Intervention

Transcutaneous Electrical Nerve Stimulation for Peripheral Neuropathy

N/A
Waitlist Available
Led By Jennifer Gewandter
Research Sponsored by University of Rochester NCORP Research Base
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Report at least 2 of the following symptoms in their lower limbs (at their worst) as at least 4 out of 10 on a 0 - 10 NRS: hot/burning pain, sharp/shooting pain, numbness, tingling, cramping at visit 1 (i.e., week -1). Use the CIPN Symptom Inventory - week recall form (questions 1-5 ONLY) to assess these symptoms at screening
Be willing and able not to start any new analgesic medications or change the dosages of any current analgesic medications (except acetaminophen [Tylenol] or non-steroidal anti-inflammatory drugs [NSAIDs] [i.e., ibuprofen (Advil, Motrin), naproxen (Aleve)]) for the duration of the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline and 6 weeks
Awards & highlights

Study Summary

This trial is testing TENS as a possible treatment for chemotherapy-induced peripheral neuropathy (CIPN). CIPN is when damage to nerves from chemotherapy affects the hands, feet, and/or legs. TENS is when electrical stimulation is passed through the skin to try and relieve pain.

Eligible Conditions
  • Peripheral Neuropathy

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline and 6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Chemotherapy-induced Peripheral Neuropathy (CIPN) Symptoms
Secondary outcome measures
Effect of TENS on Cramping
Effect of TENS on Hot/Burning Pain
Effect of TENS on Numbness
+2 more
Other outcome measures
Analgesic use
CIPN
CIPN-interference in daily life
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group I (Active TENS)Experimental Treatment2 Interventions
Patients wear an active wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity.
Group II: Group II (Placebo TENS)Placebo Group2 Interventions
Patients wear a placebo wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcutaneous Electrical Nerve Stimulation
2013
N/A
~660

Find a Location

Who is running the clinical trial?

University of Rochester NCORP Research BaseLead Sponsor
13 Previous Clinical Trials
9,048 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,495 Total Patients Enrolled
14 Trials studying Peripheral Neuropathy
1,475 Patients Enrolled for Peripheral Neuropathy
Jennifer GewandterPrincipal Investigator - University of Rochester NCORP Research Base
University of Rochester

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit to the number of individuals who can participate in this research?

"In order to properly conduct this research, 150 individuals who fit the pre-determined criteria must participate. Those who wish to help can do so at Spectrum Health at Butterworth Campus in Grand Rapids, Michigan or Decatur Memorial Hospital in Decatur, Illinois."

Answered by AI
~34 spots leftby Mar 2025