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

Study Overview
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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.

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

Conditions
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Advanced Cancer

Intervention / Treatment
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* Device: Modulated TENS
* Device: Placebo TENS


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modulated TENS<br> | Device: Modulated TENS<br>* 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)<br>|
| Placebo Comparator: Placebo TENS<br> | Device: Placebo TENS<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of mean pain intensity last 24 hours | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of worst pain intensity last 24 hours | 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 | 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 | 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 | 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 | 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 | 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 | 11-point NRS | Before and after the 24-hour-interventions and after the follow-up: at an average of one week | 
| Mood | 11-point NRS | Before and after the 24-hour-interventions and after the follow-up: at an average of one week | 
| Walking ability | 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) | 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 | 11-point NRS | Before and after the 24-hour-interventions and after the follow-up: at an average of one week | 
| Sleep | 11-point NRS | Before and after the 24-hour-interventions and after the follow-up: at an average of one week | 
| Enjoyment of life | 11-point NRS | Before and after the 24-hour-interventions and after the follow-up: at an average of one week |