UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052975 |
|---|---|
| Receipt number | R000060436 |
| Scientific Title | Development of care technology for pain and numbness as aftereffects of stroke |
| Date of disclosure of the study information | 2023/12/01 |
| Last modified on | 2023/12/05 13:24:45 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Development of care techniques to reduce (alleviate) symptoms of pain and numbness as an aftereffect of stroke
Acronym
Development of care techniques to reduce (alleviate) symptoms of pain and numbness as an aftereffect of stroke
Scientific Title
Development of care technology for pain and numbness as aftereffects of stroke
Scientific Title:Acronym
Development of care technology for pain and numbness as aftereffects of stroke
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effectiveness of hand massage as a care technique for alleviating "pain and numbness" as an aftereffect of stroke.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Pain level: VAS (Visual Analogue Scale) [before and after the intervention, and upon waking and sleeping], SF-MPQ-2 (Short-Form McGill Pain Questionnaire-2) [before intervention, 1 month after, 2 months after].
2. Presence and amount of analgesic medication [daily].
Impact on life: SF-12 (MOS 12-Item Short-Form Health Survey) [before, one month after, and two months after the intervention], HADS (Hospital Anxiety and Depression Scale) [before, one month after, and two months after the intervention], SIAS (Stroke Impairment Assessment Set) [before intervention].
4. Relaxation effect: Heart rate variability [each time during intervention].
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Hand massage for 15 minutes at intervals of once a week for 2 months (8 times in total)
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients with pain and numbness as a sequela of stroke
2.Pain and numbness intensity of 5/10 or higher on the Visual Analogue Scale (VAS)
3.Patients who can continuously participate in the care intervention for about 30 minutes once a week for 1-2 months.
4.Patients who are able to maintain a sitting position for about 30 minutes.
Key exclusion criteria
1.Patients who are judged by the attending physician, charge nurse, or principal investigator to be unsuitable as research participants at the time consent is obtained.
2.Patients who are judged by the attending physician, charge nurse, or principal investigator to be "unable to give effective informed consent due to language impairment, cognitive impairment, etc.".
3.Other patients who are judged by the principal investigator to be inappropriate as research participants.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | KAZUE |
| Middle name | |
| Last name | TOKI |
Organization
Senri Kinran University
Division name
Faculty of Nursing
Zip code
5650873
Address
5-25-1 Fujishirodai, Suita, Osaka, Japan
TEL
0668727129
k-toki@cs.kinran.ac.jp
Public contact
Name of contact person
| 1st name | KAZUE |
| Middle name | |
| Last name | TOKI |
Organization
Senri Kinran University
Division name
Faculty of Nursing
Zip code
5650873
Address
5-25-1 Fujishirodai, Suita, Osaka, Japan
TEL
0668727129
Homepage URL
k-toki@cs.kinran.ac.jp
Sponsor or person
Institute
Senri Kinran University
Institute
Department
Personal name
KAZUE TOKI
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Senri Kinran University, Human Subjects Research Ethics Review Committee
Address
Fujishirodai, Suita, Osaka, 5650873 Japan
Tel
0668720673
collabo@cs.kinran.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
| 2023 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 12 | Month | 02 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 01 | Day |
Last modified on
| 2023 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060436
