Transcutaneous Electrical Nerve Stimulation (TENS) for Advanced Cancer Pain Patients
Primary Purpose
Advanced Cancer
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Modulated TENS
Placebo TENS
Sponsored by
About this trial
This is an interventional supportive care trial for Advanced Cancer
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.
Sites / Locations
- Clinic for Palliative Care, Medical Center, University of Freiburg
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Modulated TENS
Placebo TENS
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change of worst pain intensity last 24 hours
11-point NRS
Change of least pain intensity last 24 hours
11-point NRS
Change of pain perception during TENS application on NRS
11-point NRS 0-100%; 0% = no alleviation, 100% = complete alleviation
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"
Number and percent of responders
Responders: Patients with at least "slight improvement" on VRS (see outcome before) during TENS application
Quality of life last 24 hours
Question 30 from EORTC QLQ-C30
General Activity
11-point NRS
Mood
11-point NRS
Walking ability
11-point NRS
Normal Work (includes both work outside the home and housework)
11-point NRS
Relations with other people
11-point NRS
Sleep
11-point NRS
Enjoyment of life
11-point NRS
Full Information
NCT ID
NCT02655289
First Posted
January 8, 2016
Last Updated
July 24, 2018
Sponsor
University Hospital Freiburg
1. Study Identification
Unique Protocol Identification Number
NCT02655289
Brief Title
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
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Freiburg
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Modulated TENS
Arm Type
Experimental
Arm Title
Placebo TENS
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Modulated TENS
Intervention Description
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)
Intervention Type
Device
Intervention Name(s)
Placebo TENS
Intervention Description
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)
Primary Outcome Measure Information:
Title
Change of mean pain intensity last 24 hours
Description
11-point Numerical Rating Scale (NRS): 0-10; 0=no pain; 10=pain as bad as you can imagine
Time Frame
Before and after the 24-hour-interventions and after the follow-up: at an average of one week
Secondary Outcome Measure Information:
Title
Change of worst pain intensity last 24 hours
Description
11-point NRS
Time Frame
Before and after the 24-hour-interventions and after the follow-up: at an average of one week
Title
Change of least pain intensity last 24 hours
Description
11-point NRS
Time Frame
Before and after the 24-hour-interventions and after the follow-up: at an average of one week
Title
Change of pain perception during TENS application on NRS
Description
11-point NRS 0-100%; 0% = no alleviation, 100% = complete alleviation
Time Frame
After the 24-hour-interventions and after the follow-up: at an average of one week
Title
Change of pain perception during TENS application on VRS
Description
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"
Time Frame
After the 24-hour-interventions and after the follow-up: at an average of one week
Title
Number and percent of responders
Description
Responders: Patients with at least "slight improvement" on VRS (see outcome before) during TENS application
Time Frame
After the 24-hour-interventions and after the follow-up: at an average of one week
Title
Quality of life last 24 hours
Description
Question 30 from EORTC QLQ-C30
Time Frame
Before and after the 24-hour-interventions and after the follow-up: at an average of one week
Title
General Activity
Description
11-point NRS
Time Frame
Before and after the 24-hour-interventions and after the follow-up: at an average of one week
Title
Mood
Description
11-point NRS
Time Frame
Before and after the 24-hour-interventions and after the follow-up: at an average of one week
Title
Walking ability
Description
11-point NRS
Time Frame
Before and after the 24-hour-interventions and after the follow-up: at an average of one week
Title
Normal Work (includes both work outside the home and housework)
Description
11-point NRS
Time Frame
Before and after the 24-hour-interventions and after the follow-up: at an average of one week
Title
Relations with other people
Description
11-point NRS
Time Frame
Before and after the 24-hour-interventions and after the follow-up: at an average of one week
Title
Sleep
Description
11-point NRS
Time Frame
Before and after the 24-hour-interventions and after the follow-up: at an average of one week
Title
Enjoyment of life
Description
11-point NRS
Time Frame
Before and after the 24-hour-interventions and after the follow-up: at an average of one week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhild Becker, Prof., MD, MA, MSc
Organizational Affiliation
University Medical Center Freiburg
Official's Role
Study Chair
Facility Information:
Facility Name
Clinic for Palliative Care, Medical Center, University of Freiburg
City
Freiburg
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
12774219
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.
Results Reference
background
PubMed Identifier
22419313
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.
Results Reference
background
PubMed Identifier
21435786
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.
Results Reference
background
PubMed Identifier
19853518
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.
Results Reference
background
Links:
URL
http://www.thewhpca.org/resources/global-atlas-on-end-of-life-care
Description
Worldwide Palliative Care Alliance: Global Atlas of Palliative Care at the End of Life.
Learn more about this trial
Transcutaneous Electrical Nerve Stimulation (TENS) for Advanced Cancer Pain Patients
We'll reach out to this number within 24 hrs