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

University Hospital Freiburg

Status: Completed

Conditions: Advanced Cancer

Treatments: Device: Placebo TENS; Device: Modulated TENS

Study type: Interventional

Funder types: Other

Identifiers

NCT02655289

DRKS00007990

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

Modulated TENS

Experimental group

Treatment:

Device: Modulated TENS

Placebo TENS

Placebo Comparator group

Treatment:

Device: Placebo TENS