UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024591 |
|---|---|
| Receipt number | R000028301 |
| Scientific Title | What kind of patients with subacromial pain are likely to benefit from a specific exercises strategy: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2016/10/30 |
| Last modified on | 2020/10/29 15:01:11 |
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Basic information
Public title
What kind of patients with subacromial pain are likely to benefit from a specific exercises strategy: A Randomized Controlled Trial
Acronym
What kind of patients with subacromial pain are likely to benefit from a specific exercises strategy
Scientific Title
What kind of patients with subacromial pain are likely to benefit from a specific exercises strategy: A Randomized Controlled Trial
Scientific Title:Acronym
What kind of patients with subacromial pain are likely to benefit from a specific exercises strategy
Region
| Japan |
Condition
Condition
Subacromial pain
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of our study was to examine the clinical tests for rotator cuff pathology and subacromial impingement, measured at baseline, that could predict shoulder disability and pain intensity in patients with subacromial pain after a 4 weeks training period using specific exercises, including eccentric training and scapula stabilizers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
American Shoulder and Elbow Surgeons shoulder score
Key secondary outcomes
Pain intensity
Neer impingement sign
Hawkins impingement sign
Painful arc sign
Impingement syndrome;
Jobe test
Whipple test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Eccentric excersice
Exercise was repeated 15 times in three sets once a day, three times a week for 4 weeks
Interventions/Control_2
Concentric excersice
Exercise was repeated 15 times in three sets once a day, three times a week for 4 weeks
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All patients do not have schedule for surgery. No physiotherapy could have been received prior to the study. Participants were included according to the following criteria: (1) age between 18 and 80 years, (2) an ability to complete the questionnaires, and (3) shoulder pain induced by resisted muscle testing in shoulder abduction or external rotation.
Key exclusion criteria
(1) a history of shoulder surgery, (2) a history of shoulder fractures, dislocation, cervical radiculopathy, degenerative joint disease of the shoulder, severe frozen should, or the demonstration of rotator cuff calcific tendinopathy. (3) cervical repeated movement testing affected shoulder pain.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomohiko Nishigami |
Organization
Konan Woman University
Division name
Department of Nursing and Physical Therapy
Zip code
Address
6-2-23, Morikita-machi, Higashinada-ku, Kobe, 658-0001,
TEL
0784133648
t-nishi@konan-wu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiko Nishigami |
Organization
Konan Woman University
Division name
Department of Nursing and Physical Therapy
Zip code
Address
6-2-23, Morikita-machi, Higashinada-ku, Kobe, 658-0001,
TEL
0784133648
Homepage URL
t-nishi@konan-wu.ac.jp
Sponsor or person
Institute
Konan Woman University
Institute
Department
Personal name
Funding Source
Organization
Konan Woman University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 10 | Month | 30 | 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
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
| 2016 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 27 | Day |
Last modified on
| 2020 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028301
