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

July 24, 2018 updated by: Waldemar Siemens, University Hospital Freiburg

Transcutaneous Electrical Nerve Stimulation (TENS) for Advanced Cancer Pain Patients - A Randomized, Double-blind, Placebo-controlled Cross-over Pilot Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Freiburg, Germany
        • Clinic for Palliative Care, Medical Center, University of Freiburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with cancer pain (caused by tumor or therapy; or associated with tumor) ≥ 3 on an 11-point NRS the last 24 hours
  • Age: ≥ 18 years
  • Patients receive at least 24 hours palliative care: on palliative care ward, palliative care consultant service or acute pain consultant service

Exclusion Criteria:

  • Verbal or cognitive inability to use TENS or to answer the questionnaire
  • High probability of dying within the next week
  • Pain that is not directly or indirectly related to tumor

Contraindications: Jones (2009) & Disselhoff (2012)

  • electronic implants like pacemakers
  • Metal implant on electrode site
  • Arrhythmia
  • Pregnancy
  • Epilepsy
  • Dermatological conditions or frail skin on electrode site
  • Anamnestically known distinct allergy regarding electrodes

Drop-out criteria after inclusion:

  • Patients that decide to stop TENS treatment (at any time or any reason).
  • Further treatment is not indicated due a rapid deterioration of the patients' clinical status according to the treating physician.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Modulated TENS
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)
Placebo Comparator: Placebo TENS
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of mean pain intensity last 24 hours
Time Frame: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
11-point Numerical Rating Scale (NRS): 0-10; 0=no pain; 10=pain as bad as you can imagine
Before and after the 24-hour-interventions and after the follow-up: at an average of one week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of worst pain intensity last 24 hours
Time Frame: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
11-point NRS
Before and after the 24-hour-interventions and after the follow-up: at an average of one week
Change of least pain intensity last 24 hours
Time Frame: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
11-point NRS
Before and after the 24-hour-interventions and after the follow-up: at an average of one week
Change of pain perception during TENS application on NRS
Time Frame: After the 24-hour-interventions and after the follow-up: at an average of one week
11-point NRS 0-100%; 0% = no alleviation, 100% = complete alleviation
After the 24-hour-interventions and after the follow-up: at an average of one week
Change of pain perception during TENS application on VRS
Time Frame: After the 24-hour-interventions and after the follow-up: at an average of one week
7-point verbal rating scale (VRS): 1= "very considerable deterioration", 2= "considerable deterioration", 3= "slight deterioration", 4= "unchanged", 5="slight improvement", 6= "considerable improvement", 7= "very considerable improvement"
After the 24-hour-interventions and after the follow-up: at an average of one week
Number and percent of responders
Time Frame: After the 24-hour-interventions and after the follow-up: at an average of one week
Responders: Patients with at least "slight improvement" on VRS (see outcome before) during TENS application
After the 24-hour-interventions and after the follow-up: at an average of one week
Quality of life last 24 hours
Time Frame: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
Question 30 from EORTC QLQ-C30
Before and after the 24-hour-interventions and after the follow-up: at an average of one week
General Activity
Time Frame: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
11-point NRS
Before and after the 24-hour-interventions and after the follow-up: at an average of one week
Mood
Time Frame: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
11-point NRS
Before and after the 24-hour-interventions and after the follow-up: at an average of one week
Walking ability
Time Frame: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
11-point NRS
Before and after the 24-hour-interventions and after the follow-up: at an average of one week
Normal Work (includes both work outside the home and housework)
Time Frame: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
11-point NRS
Before and after the 24-hour-interventions and after the follow-up: at an average of one week
Relations with other people
Time Frame: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
11-point NRS
Before and after the 24-hour-interventions and after the follow-up: at an average of one week
Sleep
Time Frame: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
11-point NRS
Before and after the 24-hour-interventions and after the follow-up: at an average of one week
Enjoyment of life
Time Frame: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
11-point NRS
Before and after the 24-hour-interventions and after the follow-up: at an average of one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital Freiburg

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Gerhild Becker, Prof., MD, MA, MSc, University Medical Center Freiburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DRKS00007990

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings