Transcutaneous Electrical Nerve Stimulation (TENS) for Advanced Cancer Pain Patients
- Conditions
- Advanced Cancer
- Interventions
- Device: Modulated TENSDevice: Placebo TENS
- Registration Number
- NCT02655289
- Lead Sponsor
- University Hospital Freiburg
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Modulated TENS Modulated TENS - Placebo TENS Placebo TENS -
- Primary Outcome Measures
Name Time Method Change of mean pain intensity last 24 hours 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
- Secondary Outcome Measures
Name Time Method 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 11-point NRS
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 11-point NRS
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 11-point NRS 0-100%; 0% = no alleviation, 100% = complete alleviation
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 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 After the 24-hour-interventions and after the follow-up: at an average of one week Responders: Patients with at least "slight improvement" on VRS (see outcome before) during TENS application
Quality of life last 24 hours Before and after the 24-hour-interventions and after the follow-up: at an average of one week Question 30 from EORTC QLQ-C30
General Activity Before and after the 24-hour-interventions and after the follow-up: at an average of one week 11-point NRS
Mood Before and after the 24-hour-interventions and after the follow-up: at an average of one week 11-point NRS
Walking ability Before and after the 24-hour-interventions and after the follow-up: at an average of one week 11-point NRS
Normal Work (includes both work outside the home and housework) Before and after the 24-hour-interventions and after the follow-up: at an average of one week 11-point NRS
Relations with other people Before and after the 24-hour-interventions and after the follow-up: at an average of one week 11-point NRS
Sleep Before and after the 24-hour-interventions and after the follow-up: at an average of one week 11-point NRS
Enjoyment of life Before and after the 24-hour-interventions and after the follow-up: at an average of one week 11-point NRS
Trial Locations
- Locations (1)
Clinic for Palliative Care, Medical Center, University of Freiburg
🇩🇪Freiburg, Germany