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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
20
* 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)
* 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)
Clinic for Palliative Care, Medical Center, University of Freiburg
Freiburg im Breisgau, Germany
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
Time frame: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
Change of worst pain intensity last 24 hours
11-point NRS
Time frame: 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
Time frame: 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
Time frame: 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"
Time frame: 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
Time frame: 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
Time frame: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
General Activity
11-point NRS
Time frame: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
Mood
11-point NRS
Time frame: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
Walking ability
11-point NRS
Time frame: 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
Time frame: 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
Time frame: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
Sleep
11-point NRS
Time frame: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
Enjoyment of life
11-point NRS
Time frame: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
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