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NCT Number: NCT02655289

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

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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Key information

Conditions

Advanced Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinic for Palliative Care, Medical Center, University of Freiburg

Freiburg im Breisgau, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Modulated TENS

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

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)

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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"

  5. 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

  6. 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

  7. 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

  8. Mood

    Time frame: Before and after the 24-hour-interventions and after the follow-up: at an average of one week

    11-point NRS

  9. 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

  10. 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

  11. 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

  12. Sleep

    Time frame: Before and after the 24-hour-interventions and after the follow-up: at an average of one week

    11-point NRS

  13. 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

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University Hospital Freiburg

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 14, 2016
Registry last updated
Jul 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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