UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000015314 |
| Receipt No. | 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 (Ver. 7) |
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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 | |
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| Condition | ||
| Condition | rheumatoid arthritis | |
| Classification by specialty |
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| 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 | |
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| Purpose of intervention | |
| Type of intervention | |
| Interventions/Control_1 | |
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| Eligibility | ||||
| Age-lower limit |
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| Age-upper limit |
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| 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 |
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| 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 |
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| Target sample size | 300 | |||
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| Name of lead principal investigator |
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| 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 | ||||||
| ma1sa3ru@med.osaka-cu.ac.jp | |||||||
| Public contact | |||||||
| Name of contact person |
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| 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 | |||||||
| ma1sa3ru@med.osaka-cu.ac.jp | |||||||
| Sponsor | |
| Institute | Osaka city university, Orthopedic surgery |
| Institute | |
| Department | |
| 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 |
| 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 |
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| 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. |
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| Results Delayed | |||||||
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| Baseline Characteristics | 402 hands of 201 RA group and 222 hands of 111 non-RA group |
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| Participant flow | Provide informed consent directly to the selected patients and have them give their consent in a written consent form. |
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| Adverse events | In this study, only ultrasound examination was performed and no specific adverse events were reported. |
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| 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. |
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| Progress | |||||||
| Recruitment status | Completed | ||||||
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| Other | |
| Other related information | case-control sumpling |
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| Registered date |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017798 |
