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

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.

Study Overview

• Status: Completed
• Conditions: Advanced Cancer
• Intervention / Treatment: Device: Modulated TENS; Device: Placebo TENS

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Freiburg, Germany
    • Clinic for Palliative Care, Medical Center, University of Freiburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Modulated TENS	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 Comparator: Placebo TENS	Device: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Hospital Freiburg
• Investigators: Study Chair: Gerhild Becker, Prof., MD, MA, MSc, University Medical Center Freiburg

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: January 8, 2016
• First Submitted That Met QC Criteria: January 13, 2016
• First Posted (Estimate): January 14, 2016

Study Record Updates

• Last Update Posted (Actual): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 24, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neoplasms; Cancer Pain
• Other Study ID Numbers: DRKS00007990

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No