UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036605 |
|---|---|
| Receipt number | R000041700 |
| Scientific Title | Effects of ischemic compression by family caregivers on myofascial pain |
| Date of disclosure of the study information | 2019/05/11 |
| Last modified on | 2022/04/27 20:42:02 |
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Basic information
Public title
Effects of ischemic compression by family caregivers on myofascial pain
Acronym
Ischemic compression by family caregivers
Scientific Title
Effects of ischemic compression by family caregivers on myofascial pain
Scientific Title:Acronym
Ischemic compression by family caregivers
Region
| Japan |
Condition
Condition
Myofascial pain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the efficacy and safety of ischemic compression by family caregivers
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The percentages of patients with 50% pain reduction
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Ischemic compression
The intervention period is 2 weeks
Interventions/Control_2
Control Group:
Sham ischemic compression
The intervention period is 2 weeks
Interventions/Control_3
Control Group:
No treatment
The intervention period is 2 weeks
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients receiving home care
Patients with myofascial pain
Key exclusion criteria
Uncontrolled psychiatric disease
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Hasuo |
Organization
Kansai Medical University
Division name
Department of Psychosomatic Medicine
Zip code
5730011
Address
Shinmachi 2-5-1, Hirakata, Osaka
TEL
072-804-0101
hasuohid@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Hasuo |
Organization
Kansai Medical University
Division name
Department of Psychosomatic Medicine
Zip code
5730011
Address
Shinmachi 2-5-1, Hirakata, Osaka
TEL
072-804-0101
Homepage URL
hasuohid@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Sasakawa Health Foudation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Medical University
Address
Shinmachi 2-5-1, Hirakata, Osaka
Tel
072-804-0101
h.hasuo7@gmail.com
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
| 2019 | Year | 05 | Month | 11 | Day |
Related information
URL releasing protocol
https://apm.amegroups.com/article/view/85000/html
Publication of results
Published
Result
URL related to results and publications
https://apm.amegroups.com/article/view/85000/html
Number of participants that the trial has enrolled
75
Results
The rate of 50% or more improvement of NRS score of the patient 14 days after the intervention was 64.0% in the ischemic compression group, 16.0% in the sham ischemic compression group, and 4.0% in the control group, respectively (p<0.001).
Results date posted
| 2022 | Year | 04 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Study participants included patients and their family caregivers who received home medical care from the institutions that participated in this study.
Participant flow
All 75 participants were randomized, and 71 participants (94.7%) completed the study period.
Adverse events
No adverse events occurred in any of the patients or family caregivers.
Outcome measures
The primary endpoint was the rate of 50% or more improvement of mean NRS pain score of the patient in the last 24 hours 14 days after the intervention.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 25 | Day |
Last modified on
| 2022 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041700
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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