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

Advanced Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02655289
• Other study ID #: DRKS00007990
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: March 2018

Study information

• Verified date: July 2018
• Source: University Hospital Freiburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Cancer
• Cancer Pain
• Neoplasms

Intervention

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)
• 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)

Locations

Country	Name	City	State
Germany	Clinic for Palliative Care, Medical Center, University of Freiburg	Freiburg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Freiburg

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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):1226-32. doi: 10.1016/j.pain.2010.12.009. Epub 2011 Mar 23. Review. — View Citation

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. — View Citation

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;(3):CD006276. doi: 10.1002/14651858.CD006276.pub3. Review. — View Citation

Radbruch L, Nauck F, Ostgathe C, Elsner F, Bausewein C, Fuchs M, Lindena G, Neuwöhner K, Schulenberg D. What are the problems in palliative care? Results from a representative survey. Support Care Cancer. 2003 Jul;11(7):442-51. Epub 2003 May 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Change of least 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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	General Activity	11-point NRS	Before and after the 24-hour-interventions and after the follow-up: at an average of one week
Secondary	Mood	11-point NRS	Before and after the 24-hour-interventions and after the follow-up: at an average of one week
Secondary	Walking ability	11-point NRS	Before and after the 24-hour-interventions and after the follow-up: at an average of one week
Secondary	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
Secondary	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
Secondary	Sleep	11-point NRS	Before and after the 24-hour-interventions and after the follow-up: at an average of one week
Secondary	Enjoyment of life	11-point NRS	Before and after the 24-hour-interventions and after the follow-up: at an average of one week

External Links

•   Worldwide Palliative Care Alliance: Global Atlas of Palliative Care at the End of Life.