UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061723 |
|---|---|
| Receipt number | R000066484 |
| Scientific Title | short-term clinical outcomes of shoulder manipulation under ultrasound guided cervical nerve root block and conservative therapy for frozen shoulder: a non-randomised comparative study |
| Date of disclosure of the study information | 2026/05/29 |
| Last modified on | 2026/05/28 18:01:49 |
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Basic information
Public title
short-term clinical outcomes of shoulder manipulation under ultrasound guided cervical nerve root block and conservative therapy for frozen shoulder
Acronym
clinical outcomes of shoulder manipulation under ultrasound guided cervical nerve root block and conservative therapy for frozen shoulder
Scientific Title
short-term clinical outcomes of shoulder manipulation under ultrasound guided cervical nerve root block and conservative therapy for frozen shoulder: a non-randomised comparative study
Scientific Title:Acronym
Comparison of clinical outcomes of shoulder manipulation under ultrasound guided cervical nerve root block and conservative therapy for frozen shoulder
Region
| Japan |
Condition
Condition
frozen shoulder
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study compares the treatment effects of manipulation under carvical nerve root block or conservative therapy for frozen shoulder, using a common rehabiritation protocol based on an algorithm tailored to the condition
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Disabilities of the Arm, Shoulder and Hand score after 2months
Key secondary outcomes
American shoulder and elbow surgeons score, shoulder pain and disability index,shoulder range of motion, inferior glemohumeral capsule thickness
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
In the manipulation group, manipulation under ultrasound-guided cervical nerve root brock is performed, followed by rehabilitation therapy. intra-articular injections or ultarasound-guided hydrorelease are additionally performed when clinically indicated according to pain severity and range of motion limitation.
Interventions/Control_2
In the conservative treatment group, patients underwent rehabilitation therapy. intra-articular injections or ultarasound-guided hydrorelease are additionally performed when clinically indicated according to pain severity and range of motion limitation.
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Case with two or more directions of restricted range of motion in the shoulder(flexion<120 degree, abduction<120 degree, external rotation<30 degree, internal rotation<L5)
2)Case with shoulder pain lasting for at least one month
Key exclusion criteria
Patient with rotator cuff tears requiring surgery, calcific tendinitis, osteoarthritis of shoulder, and post surgical and post traumatic shoulder condition
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shintarou |
| Middle name | |
| Last name | Kudo |
Organization
Morinomiya university of medical sience
Division name
Inclusive Medical Sciences Research Institute
Zip code
559-8611
Address
1-26-16 Nankoukita, Suminoe-ward, Osaka-city, Osaka
TEL
0666166911
kudo@morinomiya-u.ac.jp
Public contact
Name of contact person
| 1st name | Shun |
| Middle name | |
| Last name | okada |
Organization
Morinomiya University of Medical Sciences
Division name
research support center
Zip code
559-8611
Address
1-26-16 Nankoukita, Suminoe-ward, Osaka-city, Osaka
TEL
0666166911
Homepage URL
kenkyu@morinomiya-u.ac.jp
Sponsor or person
Institute
Morinomiya University of Medical Sciences
Institute
Department
Personal name
Shintarou Kudo
Funding Source
Organization
Morinomiya University of Medical Sciences
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Morinomiya University of Medical Sciences
Address
1-26-16 Nankoukita, Suminoe-ward, Osaka-city, Osaka
Tel
0666166911
kudo@morinomiya-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
大阪府
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 29 | 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
30
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
| 2025 | Year | 06 | Month | 13 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 28 | Day |
Last modified on
| 2026 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000066484
