UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027468
Receipt number R000031468
Scientific Title Relationship between alexithymia and latent trigger points in the upper trapezius
Date of disclosure of the study information 2017/05/25
Last modified on 2017/05/23 21:59:22

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Basic information

Public title

Relationship between alexithymia and latent trigger points in the upper trapezius

Acronym

Alexithymia and latent trigger points

Scientific Title

Relationship between alexithymia and latent trigger points in the upper trapezius

Scientific Title:Acronym

Alexithymia and latent trigger points

Region

Japan


Condition

Condition

healthy subject

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objective of this study was to determine the relationship between alexithymia and LTrPs in the upper trapezius in healthy subjects.

Basic objectives2

Others

Basic objectives -Others

predictive factor

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

the risk ratio for LTrP with alexithymia

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

66 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

160


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hideaki Hasuo

Organization

Kansai Medical University

Division name

Department of Psychosomatic Medicine

Zip code


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
Middle name
Last name Hideaki Hasuo

Organization

Kansai Medical University

Division name

Department of Psychosomatic Medicine

Zip code


Address

Shinmachi 2-5-1, Hirakata, Osaka

TEL

072-804-0101

Homepage URL


Email

hasuohid@hirakata.kmu.ac.jp


Sponsor or person

Institute

Akaiwa Medical Association Hospital

Institute

Department

Personal name



Funding Source

Organization

none

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


Address


Tel


Email



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 05 Month 25 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

Risk ratio for LTrP with alexithymia was 2.74).

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

Completed

Date of protocol fixation

2012 Year 05 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 07 Month 01 Day

Last follow-up date


Date of closure to data entry

2013 Year 12 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information

Significant risk factors associated with LTrPs included TAS-20 score and age.


Management information

Registered date

2017 Year 05 Month 23 Day

Last modified on

2017 Year 05 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031468


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name