Clinical trial NCT02655289: Transcutaneous Electrical Nerve Stimulation (TENS) for Advanced Cancer Pain Patients
Official title: Transcutaneous Electrical Nerve Stimulation (TENS) for Advanced Cancer Pain Patients - A Randomized, Double-blind, Placebo-controlled Cross-over Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Cancer
Lead sponsor: University Hospital Freiburg
Sponsor class: OTHER
First posted: 2016-01-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
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
Secondary outcomes:
measure: Change of worst pain intensity last 24 hours
timeFrame: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
measure: Change of least pain intensity last 24 hours
timeFrame: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
measure: Change of pain perception during TENS application on NRS
timeFrame: After the 24-hour-interventions and after the follow-up: at an average of one week
measure: Change of pain perception during TENS application on VRS
timeFrame: After the 24-hour-interventions and after the follow-up: at an average of one week
measure: Number and percent of responders
timeFrame: After the 24-hour-interventions and after the follow-up: at an average of one week
measure: Quality of life last 24 hours
timeFrame: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
measure: General Activity
timeFrame: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
measure: Mood
timeFrame: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
measure: Walking ability
timeFrame: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
measure: Normal Work (includes both work outside the home and housework)
timeFrame: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
measure: Relations with other people
timeFrame: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
measure: Sleep
timeFrame: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
measure: Enjoyment of life
timeFrame: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Clinic for Palliative Care, Medical Center, University of Freiburg
Study officials:
affiliation: University Medical Center Freiburg
name: Gerhild Becker, Prof., MD, MA, MSc
role: STUDY_CHAIR
References:
citation: 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.
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;2012(3):CD006276. doi: 10.1002/14651858.CD006276.pub3.
citation: 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.
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.