臨床研究等提出・公開システム

Date of registration	Dec. 10, 2021
Last modified on	Feb. 03, 2026
Trial ID	jRCTs032210476

Scientific Title	Effect on Brain Function by Immobilization after Arthroscopic Rotator Cuff Repair
Public Title	Effect on Brain Function by Immobilization after Arthroscopic Rotator Cuff Repair

Contact for Scientific Queries	Name	Shitara Hitoshi
	Affiliation	Gunma University Hospital
	Address	3-39-15 Showa-machi, Maebashi, Gunma
	Telephone	+81-27-220-7111
	E-mail	hshitara@gunma-u.ac.jp
Contact for Public Queries	Name	Nakase Kurumi
	Affiliation	Gunma University Hospital
	Address	3-39-15 Showa-machi, Maebashi, Gunma
	Telephone	+81-27-220-7111
	E-mail	k-fukui@gunma-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Dec. 10, 2021
Target sample size		30
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Over 20 years old 2. Right handed patients who are diagnosed with right rotator cuff tear (exclude isolated subscaplaris tear), that are small or medium size according to Cofield classification 3. Patients who are planned to get arthroscopic rotator cuff repair 4. Patients who are not diagnosed with psyciatric or neurologic disorders 5. Patients who agree to this study by written consent form
	Exclusion Criteria	1. Patients who have MRI contraindications 2. Patients who are deemed inappropriate for inclusion by a surgeon
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Rotator cuff tear
Intervention(s)		Arm A: wear sling after the surgery Arm B: no sling
Primary Outcome(s)		Brain function by fMRI
Secondary Outcome(s)		Pain, Functional assessment, Radiological assessment by MRI, Complications

Source of Monetary Support / Secondary Sponsor	Smith & Nephew

Name of Certified Review Board	Gunma University Hospital Clinical Research Review Board
Address	3-39-15 Showa-machi, Maebashi, Gunma, Japan, Gunma
Telephone	+81-27-220-8740
E-Mail	irb-jimukk-ciru@ml.gunma-u.ac.jp
Approval Status	Approval
Date of approval	Dec. 01, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	Feb. 03, 2026	(this page)	Changes
2	Jan. 30, 2024	Detail	Changes
1	Dec. 10, 2021	Detail

List of change history