UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038240 |
|---|---|
| Receipt number | R000043594 |
| Scientific Title | "Idiopathic" Shoulder Pain and Dysfunction from Carpal Tunnel Syndrome and Cubital Tunnel Syndrome |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2022/02/19 01:17:40 |
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Basic information
Public title
"Idiopathic" Shoulder Pain and Dysfunction from Carpal Tunnel Syndrome and Cubital Tunnel Syndrome
Acronym
Shoulder Pain Caused by CTS and CuTS
Scientific Title
"Idiopathic" Shoulder Pain and Dysfunction from Carpal Tunnel Syndrome and Cubital Tunnel Syndrome
Scientific Title:Acronym
Shoulder Pain Caused by CTS and CuTS
Region
| Japan |
Condition
Condition
RNP in shoulder, CTS, CuTS
Classification by specialty
| Orthopedics | Anesthesiology | Operative medicine |
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop diagnostic criteria of RNP in shoulder caused by CTS and CuTS, to validate the SFCPD hypothesis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pain scale (1 year after treatment)
Key secondary outcomes
shoulder joint ROM
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment | Maneuver |
Interventions/Control_1
1) wrist brace, 1 week
2) median, ulnar, radial nerve block, 1~3 times; (1% Lidocain 5ml + DXS 4mg) / 1 nerve
3) median nerve neurolysis, ulnar nerve transfer, radial nerve neurolysis
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Shoulder pain patients with CTS and CuTS
Key exclusion criteria
Patients who do not want treatment
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Hagiwara |
Organization
Inada Hospital
Division name
Department of orthopaedics
Zip code
630-8131
Address
46 Ohmoricho, Nara-shi, Nara, Japan
TEL
81-742-23-8815
yskh1231@gmail.com
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Hagiwara |
Organization
Inada Hospital
Division name
Department of orthopaedics
Zip code
630-8131
Address
46 Ohmoricho, Nara-shi, Nara, Japan
TEL
81-742-23-8815
Homepage URL
yskh1231@gmail.com
Sponsor or person
Institute
Inada Hospital
Institute
Department
Personal name
Funding Source
Organization
Inada Hospital
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
Inada Hospital
Address
46 Ohmoricho, Nara-shi, Nara, Japan
Tel
81-742-23-8815
yskh1231@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
| 2020 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
60
Results
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
| 2018 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | 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 | 10 | Month | 08 | Day |
Last modified on
| 2022 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043594
