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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028274
Receipt No. R000032364
Scientific Title Effects of transcutaneous electrical nerve stimulation to cancer-related pain
Date of disclosure of the study information 2017/07/20
Last modified on 2019/07/20

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Basic information
Public title Effects of transcutaneous electrical nerve stimulation to cancer-related pain
Acronym Effects of TENS to cancer-related pain
Scientific Title Effects of transcutaneous electrical nerve stimulation to cancer-related pain
Scientific Title:Acronym Effects of TENS to cancer-related pain
Region
Japan

Condition
Condition Cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 A purpose of this study is to inspect the effects of transcutaneous electric nerve stimulation (TENS) to symptoms of cancer-related pain, constipation, and nausea.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Pain(Numerical Rating Scale: NRS)(pre- and post TENS)
Key secondary outcomes Kind and quantity of analgesic(pre- and post TENS)
The number of rescue-dose(during TENS-period)
Degree of nausea and constipation(pre- and post TENS)
The number of vomitting(during TENS-period)
Stool frequency (during TENS-period)
ECOG Performance Status(pre- and post TENS)
Activity(the number of steps)(during TENS-period)
quality of life (QOL): EORTC QLQ-C15-PAL(pre- and post TENS)

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 transcutaneous electric nerve stimulation(1 week, 6 times/week, 1 time/day, 20min)
Interventions/Control_2 Non-treatment(1 week)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria The inpatient whom rehabilitation was prescribed.
The patients that evaluation and TENS are possible.
The person that a document agreement by the free will of a patient is obtained.
Key exclusion criteria The patient who was judged to be inadequate by chief physician.
The patient that overall status is poor.
The patient who puts on internal implantation such as pacemakers-type electronic equipment.
The patient who has a severe ischemic disorder.
The patient with the inguinal hernia.
The pregnant patient.
The patient who has electric allergia.
The patient whom cutaneous abnormality is found in the back.
The patient who has difficulty with communication.


Target sample size 40

Research contact person
Name of lead principal investigator
1st name Nakano
Middle name
Last name Jiro
Organization Nagasaki University
Division name Biomedical Sciences (Health Scieneces), department of physical therapy
Zip code 852-8052
Address 1-7-1 Sakamoto, Nagasaki city, Nagasaki 852-8520, Japan
TEL +81-95-819-7919
Email nakano-j@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name Nakano
Middle name
Last name Jiro
Organization Nagasaki University
Division name Biomedical Sciences (Health Scieneces), department of physical therapy
Zip code 8528052
Address 1-7-1 Sakamoto, Nagasaki city, Nagasaki 852-8520, Japan
TEL +81-95-819-7919
Homepage URL
Email nakano-j@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University
Institute
Department

Funding Source
Organization Nagasaki University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nagasaki University
Address 1-7-1 Sakamoto, Nagasaki city, Nagasaki 852-8520, Japan
Tel +81-95-819-7919
Email nakano-j@nagasaki-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 20 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 20
Results
Finally, 20 patients completed the study.
When the average pain NRS score during the day were compared between pre- and post- intervention, there was a significant reduction in the score during the TENS-phase (p < 0.01). When the scores of physical symptoms were compared between pre- and post-intervention, a significant reduction in pain (p < 0.01), nausea/vomiting (p = 0.04), and appetite loss (p = 0.02) was shown in the TENS-phase. 
Results date posted
2019 Year 07 Month 20 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 08 Month 09 Day
Date of IRB
2017 Year 09 Month 11 Day
Anticipated trial start date
2017 Year 08 Month 22 Day
Last follow-up date
2019 Year 01 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 15 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 18 Day
Last modified on
2019 Year 07 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032364

Research Plan
Registered date File name
2018/07/19 7-15-1研究計画書_中野_修正.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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