UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028274 |
|---|---|
| Receipt number | 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 14:39:27 |
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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
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
nakano-j@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032364
