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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2018-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Advanced Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Modulated TENS

Group Type EXPERIMENTAL

Modulated TENS

Intervention Type DEVICE

* 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 TENS

Group Type PLACEBO_COMPARATOR

Placebo TENS

Intervention Type DEVICE

* 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)

Interventions

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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)

Intervention Type 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)

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No