Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Modulated TENS | Device | — | UNRESOLVED |
| Placebo TENS | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Modulated TENS
- interventionNames
- Device: Modulated TENS
- type
- PLACEBO_COMPARATOR
- label
- Placebo TENS
- interventionNames
- Device: Placebo TENS
Primary outcomes (1)
- measure
- Change of mean pain intensity last 24 hours
- timeFrame
- Before and after the 24-hour-interventions and after the follow-up: at an average of one week
- description
- 11-point Numerical Rating Scale (NRS): 0-10; 0=no pain; 10=pain as bad as you can imagine
Secondary outcomes (13)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (4)
- BACKGROUNDRadbruch L, Nauck F, Ostgathe C, Elsner F, Bausewein C, Fuchs M, Lindena G, Neuwohner K, Schulenberg D. What are the problems in palliative care? Results from a representative survey. Support Care Cancer. 2003 Jul;11(7):442-51. doi: 10.1007/s00520-003-0472-6. Epub 2003 May 28. PMID 12774219
- BACKGROUNDHurlow A, Bennett MI, Robb KA, Johnson MI, Simpson KH, Oxberry SG. Transcutaneous electric nerve stimulation (TENS) for cancer pain in adults. Cochrane Database Syst Rev. 2012 Mar 14;2012(3):CD006276. doi: 10.1002/14651858.CD006276.pub3. PMID 22419313
- BACKGROUNDBennett MI, Hughes N, Johnson MI. Methodological quality in randomised controlled trials of transcutaneous electric nerve stimulation for pain: low fidelity may explain negative findings. Pain. 2011 Jun;152(6):1226-1232. doi: 10.1016/j.pain.2010.12.009. Epub 2011 Mar 23. PMID 21435786
- BACKGROUNDBennett MI, Johnson MI, Brown SR, Radford H, Brown JM, Searle RD. Feasibility study of Transcutaneous Electrical Nerve Stimulation (TENS) for cancer bone pain. J Pain. 2010 Apr;11(4):351-9. doi: 10.1016/j.jpain.2009.08.002. Epub 2009 Oct 22. PMID 19853518