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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modulated TENS | Experimental |
| |
| Placebo TENS | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modulated TENS | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Before and after the 24-hour-interventions and after the follow-up: at an average of one week |
| Measure | Description | Time Frame |
|---|---|---|
| Change of worst pain intensity last 24 hours | 11-point NRS | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Contraindications: Jones (2009) & Disselhoff (2012)
Drop-out criteria after inclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Gerhild Becker, Prof., MD, MA, MSc | University Medical Center Freiburg | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinic for Palliative Care, Medical Center, University of Freiburg | Freiburg im Breisgau | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12774219 | Background | Radbruch 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. | |
| 22419313 | Background | Hurlow 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. |
| Label | URL |
|---|---|
| Worldwide Palliative Care Alliance: Global Atlas of Palliative Care at the End of Life. | View source |
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|
| Placebo TENS | Device |
|
|
11-point NRS
| 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 | 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" | 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 | 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 | Before and after the 24-hour-interventions and after the follow-up: at an average of one week |
| General Activity | 11-point NRS | Before and after the 24-hour-interventions and after the follow-up: at an average of one week |
| Mood | 11-point NRS | Before and after the 24-hour-interventions and after the follow-up: at an average of one week |
| Walking ability | 11-point NRS | 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 | 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 | Before and after the 24-hour-interventions and after the follow-up: at an average of one week |
| Sleep | 11-point NRS | Before and after the 24-hour-interventions and after the follow-up: at an average of one week |
| Enjoyment of life | 11-point NRS | Before and after the 24-hour-interventions and after the follow-up: at an average of one week |
| 21435786 | Background | Bennett 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. |
| 19853518 | Background | Bennett 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. |