NCT02655289

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 14, 2016

Completed
18 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

July 26, 2018

Status Verified

July 1, 2018

Enrollment Period

2.1 years

First QC Date

January 8, 2016

Last Update Submit

July 24, 2018

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (13)

  • Change of worst pain intensity last 24 hours

    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

    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

    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

    After the 24-hour-interventions and after the follow-up: at an average of one week

  • Number and percent of responders

    After the 24-hour-interventions and after the follow-up: at an average of one week

  • +8 more secondary outcomes

Study Arms (2)

Modulated TENS

EXPERIMENTAL
Device: Modulated TENS

Placebo TENS

PLACEBO COMPARATOR
Device: Placebo TENS

Interventions

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)

Modulated TENS
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)

Placebo TENS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic for Palliative Care, Medical Center, University of Freiburg

Freiburg im Breisgau, Germany

Location

Related Publications (4)

  • 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.

    PMID: 12774219BACKGROUND

  • 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.

    PMID: 22419313BACKGROUND

  • 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.

    PMID: 21435786BACKGROUND

  • 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.

    PMID: 19853518BACKGROUND

Related Links

Study Officials

  • Gerhild Becker, Prof., MD, MA, MSc

    University Medical Center Freiburg

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

January 8, 2016

First Posted

January 14, 2016

Study Start

February 1, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

July 26, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)