UMIN-CTR Clinical Trial

Basic information
Public title	Post-operative pain relief for patients undergoing arthroscopic shoulder surgery - an investigation of the efficacy of cryotherapy
Acronym	The effect of cryotherapy on pain relief
Scientific Title	Post-operative pain relief for patients undergoing arthroscopic shoulder surgery - an investigation of the efficacy of cryotherapy
Scientific Title:Acronym	The effect of cryotherapy on pain relief
Region	Japan

Condition
Condition	rotator cuff injury, shoulder joint dislocation etc.
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We plan to elucidate the optimum application temperature and duration, and other factors influencing pain and distress, in patients receiving cryotherapy after arthroscopic shoulder surgery, in order to develop comfortable and effective methods of cryotherapy.
Basic objectives2	Others
Basic objectives -Others	Cryotherapy is a treatment we are conducting as a part of postoperative management after shoulder arthroscopic surgery from October 2009 in this hospital and has not admitted the occurrence of serious adverse events such as circulation disorder so far .
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Shoulder joint temperature (skin temperature and deep temperature) and body temperature during cryotherapy:Up to 24 hours after operation
Key secondary outcomes	Objective assessment of pain intensity-Device for quantitative analysis of perception and pain sensation,Visual analogue scale(VAS),Using analgesics-Up to 48 hours after operation blood pressure,Pulse rate-Up to 24 hours after operation C reactive protein (CRP)-Up to 7 days after surgery Questionnaire survey on pain-Survey by 3 days after surgery

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Temperature and time of cryotherapy for 24h at 5degrees
Interventions/Control_2	Temperature and time of cryotherapy for 16h at 5degrees
Interventions/Control_3	Temperature and time of cryotherapy for 24h at 10degrees
Interventions/Control_4	Temperature and time of cryotherapy for 16h at 10degrees
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	16 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	Patients over the age of 16 who undergo shoulder arthroscopic surgery
Key exclusion criteria	Patient whose scheduled surgery was discontinued (patient who did not undergo shoulder arthroscopic surgery) Patients who did not have the necessary data Patients judged inappropriate as the subject to be administered
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Etsuo Middle name Last name Cyosa
Organization	Faculty of Medicine, University of Miyazaki
Division name	Department of Orthopaedic surgery
Zip code	889-1692
Address	5200 Kihara Kiyotake-cho miyazaki-shi Miyazaki
TEL	0985-85-0986
Email	cyosa@med.miyazaki-u.ac.jp

Public contact
Name of contact person	1st name Rinko Middle name Last name Uchida
Organization	Faculty of Medicine, University of Miyazaki
Division name	School of Nursing,Adult Health and Gerontological Nursing
Zip code	889-1692
Address	5200 Kihara Kiyotake-cho miyazaki-shi Miyazaki
TEL	0985-85-9827
Homepage URL
Email	rinko_uchida@med.miyazaki-u.ac.jp

Sponsor
Institute	Faculty of Medicine, University of Miyazaki,Department of Orthopaedic surgery
Institute
Department

Funding Source
Organization	Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Faculty of Medicine, University of Miyazaki
Address	5200 Kihara Kiyotake-cho miyazaki-shi Miyazaki
Tel	0985-85-9827
Email	rinko_uchida@med.miyazaki-u.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	宮崎大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	62
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	The results of this study are important. It will be published after being published in the posting magazine.We are preparing a study paper now.
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	2017 Year 03 Month 15 Day
Date of IRB	2015 Year 11 Month 02 Day
Anticipated trial start date	2017 Year 03 Month 30 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 03 Month 31 Day
Last modified on	2020 Year 10 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030737