UMIN-CTR Clinical Trial

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
Email	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
Email	yskh1231@gmail.com

Sponsor
Institute	Inada Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043594