UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038141 |
|---|---|
| Receipt number | R000043475 |
| Scientific Title | Efficacy of fascia-release of coraco-humeral ligament in frozen shoulder: change in the range of motion of first external rotation |
| Date of disclosure of the study information | 2019/10/04 |
| Last modified on | 2022/04/20 00:03:55 |
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Basic information
Public title
Efficacy of fascia-release of coraco-humeral ligament in frozen shoulder: change in the range of motion of first external rotation
Acronym
Efficacy of fascia-release of coraco-humeral ligament in frozen shoulder: change in the range of motion of first external rotation
Scientific Title
Efficacy of fascia-release of coraco-humeral ligament in frozen shoulder: change in the range of motion of first external rotation
Scientific Title:Acronym
Efficacy of fascia-release of coraco-humeral ligament in frozen shoulder: change in the range of motion of first external rotation
Region
| Japan |
Condition
Condition
frozen shoulder/adhesive capsulitis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate efficacy and safety of ultrasound-guided fascia hydrorelease on coracohumeral ligament (CHL) to the patients with frozen shoulder who have range of motion (ROM) restriction of shoulder first external rotation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change in passive ROM (pROM) of shoulder first external rotation before and after the fascia hydrorelease to CHL on the first visit.
Key secondary outcomes
The change in pROM of shoulder first external rotation before and after the fascia hydrorelease to CHL on the second visit (1 week interval).
The change in active ROM (aROM) of shoulder first external rotation, aROM and pROM of shoulder flexion, extention, abduction, 1st internal rotation, 2nd internal/external rotation, 3rd internal/external rotation, as well as the pain visual analogue scale (VAS) at rest/ on first external rotation, shoulder pain and disability index (SPADI) before and after the fascia hydrorelease to CHL on the first and second visit.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Ultrasound-guided fascia hydrorelease of CHL on the first and the second visit. In detail, we inject 2ml of normal saline to CHL all over its layers.
Rehabilitation for frozen shoulder on the second visit.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients are included if they have clinical diagnosis of frozen shoulder with severe restriction in both aROM and pROM of first external rotation (defined by equal to or less than 30% of the normal ROM: 60 degrees for aROM and 90 degrees for pROM), and if they choose the treatment with fascia hydrorelease.
Key exclusion criteria
Patients are excluded if they do not accept the consent form, or if they have apparent subacromial bursitis or calcified tendonitis with ultrasound examination.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Kimura |
Organization
Kimura Pain Clinic
Division name
N/A
Zip code
371-0013
Address
379-1 Nishikatagaicho, Maebashi-city, Gumma, Japan
TEL
+81-27-220-1055
kimura72@jcom.home.ne.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Kimura |
Organization
Kimura Pain Clinic
Division name
N/A
Zip code
371-0013
Address
379-1 Nishikatagaicho, Maebashi-city, Gumma, Japan
TEL
+81-27-220-1055
Homepage URL
kimura72@jcom.home.ne.jp
Sponsor or person
Institute
Kimura Pain Clinic
Institute
Department
Personal name
Funding Source
Organization
none
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
Fukushima Medical University
Address
1 Hikarigaoka, Fukushima-shi, Fukushima, Japan
Tel
81-24-547-1111
rs@fmu.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 04 | 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
| 2019 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 28 | Day |
Last modified on
| 2022 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043475
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
