ID

23279

Description

Responsible Party: Waldemar Siemens, MSc, University Hospital Freiburg ClinicalTrials.gov Identifier: NCT02655289 History of Changes Other Study ID Numbers: DRKS00007990 Study First Received: January 8, 2016 Last Updated: May 2, 2017 Transcutaneous Electrical Nerve Stimulation (TENS) for Advanced Cancer Pain Patients ODM derived from: https://clinicaltrials.gov/ct2/show/NCT02655289

Link

https://clinicaltrials.gov/ct2/show/NCT02655289

Keywords

  1. 7/2/17 7/2/17 -
Uploaded on

July 2, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility TENS for Cancer Pain Patients DRKS00007990 NCT02655289 DRKS00007990

Eligibility TENS for Cancer Pain Patients NCT02655289 DRKS00007990

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Patients with cancer pain (caused by tumor or therapy; or associated with tumor) ≥ 3 on an 11-point NRS the last 24 hours
Description

Cancer Pain

Data type

boolean

Alias
UMLS CUI [1]
C0596240
Age: ≥ 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Patients receive at least 24 hours palliative care: on palliative care ward, palliative care consultant service or acute pain consultant service
Description

Palliative Care

Data type

boolean

Alias
UMLS CUI [1]
C0030231
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Verbal or cognitive inability to use TENS or to answer the questionnaire
Description

Language Ability, Cognitive Impairment

Data type

boolean

Alias
UMLS CUI [1]
C1145677
UMLS CUI [2]
C0338656
High probability of dying within the next week
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
Pain that is not directly or indirectly related to tumor
Description

Pain

Data type

boolean

Alias
UMLS CUI [1]
C0030193
Contraindications: Jones (2009) & Disselhoff (2012): Electronic implants like pacemakers
Description

Electronic implants

Data type

boolean

Alias
UMLS CUI [1]
C0021102
Contraindications: Jones (2009) & Disselhoff (2012): Metal implant on electrode site
Description

Metal implant

Data type

boolean

Alias
UMLS CUI [1]
C0336580
Contraindications: Jones (2009) & Disselhoff (2012): Arrhythmia
Description

Arrhythmia

Data type

boolean

Alias
UMLS CUI [1]
C0003811
Contraindications: Jones (2009) & Disselhoff (2012): Pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
Contraindications: Jones (2009) & Disselhoff (2012): Epilepsy
Description

Epilepsy

Data type

boolean

Alias
UMLS CUI [1]
C0014544
Contraindications: Jones (2009) & Disselhoff (2012): Dermatological conditions or frail skin on electrode site
Description

Dermatologic disorders

Data type

boolean

Alias
UMLS CUI [1]
C0037274
Contraindications: Jones (2009) & Disselhoff (2012): Anamnestically known distinct allergy regarding electrodes
Description

Hypersensitivity

Data type

boolean

Alias
UMLS CUI [1]
C0020517
Drop-out criteria after inclusion: Patients that decide to stop TENS treatment (at any time or any reason).
Description

Discontinuation

Data type

boolean

Alias
UMLS CUI [1]
C0457454
Drop-out criteria after inclusion: Further treatment is not indicated due a rapid deterioration of the patients' clinical status according to the treating physician.
Description

Health Status

Data type

boolean

Alias
UMLS CUI [1]
C0018759
Healthy Volunteers
Description

Control Group

Data type

boolean

Alias
UMLS CUI [1]
C0009932

Similar models

Eligibility TENS for Cancer Pain Patients NCT02655289 DRKS00007990

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Cancer Pain
Item
Patients with cancer pain (caused by tumor or therapy; or associated with tumor) ≥ 3 on an 11-point NRS the last 24 hours
boolean
C0596240 (UMLS CUI [1])
Age
Item
Age: ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Palliative Care
Item
Patients receive at least 24 hours palliative care: on palliative care ward, palliative care consultant service or acute pain consultant service
boolean
C0030231 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Language Ability, Cognitive Impairment
Item
Verbal or cognitive inability to use TENS or to answer the questionnaire
boolean
C1145677 (UMLS CUI [1])
C0338656 (UMLS CUI [2])
Life Expectancy
Item
High probability of dying within the next week
boolean
C0023671 (UMLS CUI [1])
Pain
Item
Pain that is not directly or indirectly related to tumor
boolean
C0030193 (UMLS CUI [1])
Electronic implants
Item
Contraindications: Jones (2009) & Disselhoff (2012): Electronic implants like pacemakers
boolean
C0021102 (UMLS CUI [1])
Metal implant
Item
Contraindications: Jones (2009) & Disselhoff (2012): Metal implant on electrode site
boolean
C0336580 (UMLS CUI [1])
Arrhythmia
Item
Contraindications: Jones (2009) & Disselhoff (2012): Arrhythmia
boolean
C0003811 (UMLS CUI [1])
Pregnancy
Item
Contraindications: Jones (2009) & Disselhoff (2012): Pregnancy
boolean
C0032961 (UMLS CUI [1])
Epilepsy
Item
Contraindications: Jones (2009) & Disselhoff (2012): Epilepsy
boolean
C0014544 (UMLS CUI [1])
Dermatologic disorders
Item
Contraindications: Jones (2009) & Disselhoff (2012): Dermatological conditions or frail skin on electrode site
boolean
C0037274 (UMLS CUI [1])
Hypersensitivity
Item
Contraindications: Jones (2009) & Disselhoff (2012): Anamnestically known distinct allergy regarding electrodes
boolean
C0020517 (UMLS CUI [1])
Discontinuation
Item
Drop-out criteria after inclusion: Patients that decide to stop TENS treatment (at any time or any reason).
boolean
C0457454 (UMLS CUI [1])
Health Status
Item
Drop-out criteria after inclusion: Further treatment is not indicated due a rapid deterioration of the patients' clinical status according to the treating physician.
boolean
C0018759 (UMLS CUI [1])
Control Group
Item
Healthy Volunteers
boolean
C0009932 (UMLS CUI [1])

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