NCT02655289

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University Hospital Freiburg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Cancer

Interventions

Type	Name	Description
DEVICE	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)
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)

Timeline

• Start date: 2016-02-01
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2016-01-14
• Last updated: 2018-07-26

Locations

1 site across 1 country: Germany