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

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 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

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

Value
https://center6.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