UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015314
Receipt number R000017798
Scientific Title The assessment of median nerve elasticity in patients with rheumatoid arthritis by using elastosonography (multicenter clinical study)
Date of disclosure of the study information 2014/10/01
Last modified on 2020/03/16 18:42:34

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Basic information

Public title

The assessment of median nerve elasticity in patients with rheumatoid arthritis by using elastosonography (multicenter clinical study)

Acronym

The assessment of median nerve elasticity in patients with rheumatoid arthritis

Scientific Title

The assessment of median nerve elasticity in patients with rheumatoid arthritis by using elastosonography (multicenter clinical study)

Scientific Title:Acronym

The assessment of median nerve elasticity in patients with rheumatoid arthritis

Region

Japan


Condition

Condition

rheumatoid arthritis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to measure the median nerve stiffness by using elastosonography at the carpal tunnel level and check subclinical damage of the median nerve. The median nerve stiffness of patients with rheumatoid arthritis is compared to the stiffness of healthy control.

Basic objectives2

Others

Basic objectives -Others

This study is cross sectional study without any intervention.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

To compare the median nerve stiffness of patients with rheumatoid arthritis with healthy controls

Key secondary outcomes

To compare the median nerve cross sectional area of patients with rheumatoid arthritis with healthy controls


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


Not applicable

Gender

Male and Female

Key inclusion criteria

1)1.patients with rheumatoid arthritis, 2.healthy controls
1)both men and women who are over 20 years old
3)participants who accepted to join our study

Key exclusion criteria

1)participants who have a possibility of secondary carpal tunnel syndrome (diabetes mellitus, acute trauma, pregnancy, hypothyroidism, hyperthyroidism, rheumatic disease except for rheumatoid arthritis)
2)double crush syndrome patients (with cervical spondylosis)
3)cervical spondylotic myelopathy patients
4)poly myelopathy patients
5)patients who have previous fracture of wrist
6)patients who have previous surgery of wrist
7)participants who are considered to join this study is not appropriated

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Tadashi
Middle name
Last name Okano

Organization

Osaka city university

Division name

Orthopedic surgery

Zip code

545-8585

Address

1-4-3 Asahimachi, Abenoku, Osaka city, Osaka

TEL

06-6645-3851

Email

ma1sa3ru@med.osaka-cu.ac.jp


Public contact

Name of contact person

1st name Tadashi
Middle name
Last name Okano

Organization

Osaka city university

Division name

Orthopedic surgery

Zip code

545-8585

Address

1-4-3 Asahimachi, Abenoku, Osaka city, Osaka

TEL

06-6645-3851

Homepage URL


Email

ma1sa3ru@med.osaka-cu.ac.jp


Sponsor or person

Institute

Osaka city university, Orthopedic surgery

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

Osaka city university

Address

1-2-7 Asahimachi, Abenoku, Osaka city, Osaka

Tel

06-6645-3435

Email

ethics@med.osaka-cu.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

大阪市立大学大学院医学研究科


Other administrative information

Date of disclosure of the study information

2014 Year 10 Month 01 Day


Related information

URL releasing protocol

http://www.med.osaka-cu.ac.jp/orthoped/research/

Publication of results

Published


Result

URL related to results and publications

https://www.tandfonline.com/doi/abs/10.1080/14397595.2019.1602914?journalCode=imor20

Number of participants that the trial has enrolled

312

Results

The nerve stiffness in patients with RA measured by ultrasound real-time tissue elastography was higher than without RA. Inflammatory condition of the flexor tendon and wrist joint in patients with RA may generate fibrotic changes in the median nerve.

Results date posted

2020 Year 03 Month 16 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

402 hands of 201 RA group and 222 hands of 111 non-RA group

Participant flow

Provide informed consent directly to the selected patients and have them give their consent in a written consent form.

Adverse events

In this study, only ultrasound examination was performed and no specific adverse events were reported.

Outcome measures

Ultrasonography was performed to evaluate the circumference, cross-sectional area (CSA) and strain ratio as an elasticity of the median nerve at the inlet level of the carpal tunnel and the proximal portion of the carpal tunnel inlet.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2014 Year 04 Month 01 Day

Date of IRB

2014 Year 03 Month 05 Day

Anticipated trial start date

2014 Year 10 Month 01 Day

Last follow-up date

2017 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

case-control sumpling


Management information

Registered date

2014 Year 10 Month 01 Day

Last modified on

2020 Year 03 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017798


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name