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Transcutaneous Electrical Nerve Stimulation (TENS) for Advanced Cancer Pain Patients

NCT02655289 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-07-26

No results posted yet for this study

Summary

Pain is the most common symptom (ca. 80% of patients) on German Palliative Care units and thus, pain control plays a central role in palliative care.

Transcutaneous electrical nerve stimulation (TENS) is a complementary treatment option for patients who experience suboptimal pain control. However, the evidence for the efficacy of TENS in cancer patients is not unambiguous.

The present study is a double blind, placebo-controlled cross-over trial with a short-term follow-up.

The primary aim of this study is to evaluate the efficacy and safety of TENS for cancer pain reduction in advanced cancer patients.

The secondary aim is the explorative identification of subgroups that benefit or do not benefit from TENS.

Conditions

Interventions

DEVICE

Modulated TENS

* Frequency: 100 Hz * Intensity: individual; TENS should be clearly perceptible but not painful; impulse width is coupled with intensity * Mode: intensity modulation (40% decrease every 0.5 seconds) * TENS device: ARTROSTIM® SELECT * Channels: 2 * Electrodes: 4 (5x5cm), placed on site of pain (a little more proximal if allodynia is present)

DEVICE

Placebo TENS

* Frequency: 100 Hz (conventional for High TENS; Placebo is achieved by reduction of intensity, see below) * Intensity: The device is on and will be up-regulated together until the first sensation is perceptible. Then the activated device will be down-regulated minimally (no sensation perceptible) and this configuration will be retained. * Mode: continuous * TENS device: ARTROSTIM® SELECT * Channels: 2 * Electrodes: 4 (5x5cm), placed on site of pain (a little proximal if allodynia is present)

Sponsors & Collaborators

  • University Hospital Freiburg

    lead OTHER

Principal Investigators

  • Gerhild Becker, Prof., MD, MA, MSc · University Medical Center Freiburg

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2018-03-31
Completion
2018-03-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02655289 on ClinicalTrials.gov