UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026796 |
|---|---|
| Receipt number | R000030737 |
| Scientific Title | Post-operative pain relief for patients undergoing arthroscopic shoulder surgery - an investigation of the efficacy of cryotherapy |
| Date of disclosure of the study information | 2017/03/31 |
| Last modified on | 2020/10/02 09:32:36 |
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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
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
rinko_uchida@med.miyazaki-u.ac.jp
Sponsor or person
Institute
Faculty of Medicine, University of Miyazaki,Department of Orthopaedic surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030737
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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