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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038360
Receipt No. R000043716
Scientific Title Relationship between Alexisomia and latent trigger points in the upper trapezius
Date of disclosure of the study information 2019/10/22
Last modified on 2019/10/22

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Basic information
Public title Relationship between Alexisomia and latent trigger points in the upper trapezius
Acronym Alexisomia and trigger points
Scientific Title Relationship between Alexisomia and latent trigger points in the upper trapezius
Scientific Title:Acronym Alexisomia and trigger points
Region
Japan

Condition
Condition Latent trigger point
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The main objective of the present study was to investigate the relationship between alexisomia and latent trigger points in the upper trapezius of healthy subjects.
Basic objectives2 Others
Basic objectives -Others predictive factor
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes LTrP risk ratio for individuals with alexisomia
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria healthy subject
Key exclusion criteria The study had 3 exclusion criteria, 1) chronic pain in the upper trapezius area, 2) history of physical therapy or postoperative rehabilitation for the treatment of musculoskeletal disorders, and 3) history of psychiatric treatment.
Target sample size 154

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
Email 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
Email hasuohid@hirakata.kmu.ac.jp

Sponsor
Institute Kansai Medical University
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
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
Email hasuohid@hirakata.kmu.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
2019 Year 10 Month 22 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 154
Results
Risk ratio for latent trigger point with alexithymia was 2.30. 
Results date posted
2019 Year 10 Month 22 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
2019 Year 04 Month 01 Day
Date of IRB
2019 Year 05 Month 24 Day
Anticipated trial start date
2019 Year 06 Month 01 Day
Last follow-up date
2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
2019 Year 10 Month 10 Day
Date analysis concluded
2019 Year 10 Month 15 Day

Other
Other related information Significant risk factors associated with latent trigger point included difficulty of identifying bodily feelings.

Management information
Registered date
2019 Year 10 Month 22 Day
Last modified on
2019 Year 10 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043716

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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