Advanced CancerNCT02655289
Transcutaneous Electrical Nerve Stimulation (TENS) for Advanced Cancer Pain Patients
A study testing Modulated TENS in people with Advanced Cancer, run by University Hospital Freiburg at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Modulated TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2016to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinic for Palliative Care, Medical Center, University of Freiburg
Freiburg im Breisgau
About this study
Official title: 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.
Read more
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.
- Conditions
- Advanced Cancer
- Being tested
- Modulated TENS, Placebo TENS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modulated TENSDevice
- 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 TENSDevice
- 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)
| Study group | Role | What they receive |
|---|---|---|
| Modulated TENS | Experimental | Not described Receives: Device: Modulated TENS |
| Placebo TENS | Placebo comparator | Not described Receives: Device: Placebo TENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
Secondary outcomes (13)
Change of worst pain intensity last 24 hours
11-point NRS
Measured: 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
Measured: 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
Measured: 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"
Measured: 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
Measured: 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
Measured: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
General Activity
11-point NRS
Measured: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
Mood
11-point NRS
Measured: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
Walking ability
11-point NRS
Measured: 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
Measured: 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
Measured: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
Sleep
11-point NRS
Measured: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
Enjoyment of life
11-point NRS
Measured: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waldemar Siemens, University Hospital Freiburg
- Investigators
- Gerhild Becker, Prof., MD, MA, MSc, Study chair, University Medical Center Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02655289
- Sponsor's protocol ID
- DRKS00007990
- Status last verified
- Jul 2018
- First submitted
- 8 Jan 2016
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 12774219Hurlow 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.
PubMed 22419313Bennett 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.
PubMed 21435786Bennett 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.
PubMed 19853518
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrical Nerve Stimulation (TENS) for Advanced Cancer Pain Patients - A Randomized, Double-blind, Placebo-controlled Cross-over Pilot Study
- ClinicalTrials.gov ID
- NCT02655289
- Acronym / sponsor ID
- DRKS00007990
- Conditions
- Advanced Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 14 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modulated TENS | Experimental | Device: Modulated TENS |
| Placebo TENS | Placebo comparator | Device: Placebo TENS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Device | Modulated TENS |
| 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) | Device | Placebo TENS |
Primary outcome
Change of mean pain intensity last 24 hours
Time frame: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
11-point Numerical Rating Scale (NRS): 0-10; 0=no pain; 10=pain as bad as you can imagine
13 secondary outcomes
Change of worst pain intensity last 24 hours
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: After the 24-hour-interventions and after the follow-up: at an average of one week
Number and percent of responders
Time frame: After the 24-hour-interventions and after the follow-up: at an average of one week
Quality of life last 24 hours
Time frame: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
General Activity
Time frame: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
Mood
Time frame: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
Walking ability
Time frame: 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)
Time frame: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
Relations with other people
Time frame: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
Sleep
Time frame: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
Enjoyment of life
Time frame: Before and after the 24-hour-interventions and after the follow-up: at an average of one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- Background: PubMed 12774219Radbruch 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.
- Background: PubMed 22419313Hurlow 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.
- Background: PubMed 21435786Bennett 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.
- Background: PubMed 19853518Bennett 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.
- Worldwide Palliative Care Alliance: Global Atlas of Palliative Care at the End of Life.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerhild Becker, Prof., MD, MA, MSc study chair
University Medical Center Freiburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modulated TENS in people with Advanced Cancer, run by University Hospital Freiburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of mean pain intensity last 24 hours (time frame: Before and after the 24-hour-interventions and after the follow-up: at an average of one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02655289, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2018.