Advanced Cancer
Conditions
Brief summary
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.
Interventions
DEVICEModulated 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)
DEVICEPlacebo 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)
Sponsors
University Hospital Freiburg
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of mean pain intensity last 24 hours | 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
| Measure | Time frame | Description |
|---|---|---|
| Change of least pain intensity last 24 hours | Before and after the 24-hour-interventions and after the follow-up: at an average of one week | 11-point NRS |
| Change of pain perception during TENS application on NRS | 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 |
| Change of pain perception during TENS application on VRS | 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 |
| Number and percent of responders | 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 |
| Quality of life last 24 hours | Before and after the 24-hour-interventions and after the follow-up: at an average of one week | Question 30 from EORTC QLQ-C30 |
| General Activity | Before and after the 24-hour-interventions and after the follow-up: at an average of one week | 11-point NRS |
| Change of worst pain intensity last 24 hours | Before and after the 24-hour-interventions and after the follow-up: at an average of one week | 11-point NRS |
| Walking ability | Before and after the 24-hour-interventions and after the follow-up: at an average of one week | 11-point NRS |
| Normal Work (includes both work outside the home and housework) | Before and after the 24-hour-interventions and after the follow-up: at an average of one week | 11-point NRS |
| Relations with other people | Before and after the 24-hour-interventions and after the follow-up: at an average of one week | 11-point NRS |
| Sleep | Before and after the 24-hour-interventions and after the follow-up: at an average of one week | 11-point NRS |
| Enjoyment of life | Before and after the 24-hour-interventions and after the follow-up: at an average of one week | 11-point NRS |
| Mood | Before and after the 24-hour-interventions and after the follow-up: at an average of one week | 11-point NRS |
Countries
Germany
Outcome results
None listed