UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060264 |
|---|---|
| Receipt number | R000067433 |
| Scientific Title | Evaluation of Vascularity Assessment Using power Doppler Ultrasound in Patients with Frozen Shoulder and Examination of the Immediate and Mid- to Long-term Effects of Extracorporeal Shock Wave Therapy |
| Date of disclosure of the study information | 2026/01/05 |
| Last modified on | 2026/01/05 23:46:03 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study on the Effects of Extracorporeal Shock Wave Therapy for Frozen Shoulder and Prognostic Evaluation Based on Vascularity Assessment
Acronym
Study on Extracorporeal Shock Wave Therapy and Vascularity Assessment in Frozen Shoulder
Scientific Title
Evaluation of Vascularity Assessment Using power Doppler Ultrasound in Patients with Frozen Shoulder and Examination of the Immediate and Mid- to Long-term Effects of Extracorporeal Shock Wave Therapy
Scientific Title:Acronym
Study on Vascularity Assessment and Extracorporeal Shock Wave Therapy in Frozen Shoulder
Region
| Japan |
Condition
Condition
Frozen shoulder
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the relationship between vascularity assessed by power Doppler ultrasonography and both the immediate and medium-to-long-term effects of extracorporeal shock wave therapy in patients with frozen shoulder.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Shoulder joint range of motion
Key secondary outcomes
1. Correlation between vascularity assessment using power Doppler and treatment efficacy
2. Changes in pain VAS scores
3. Changes in patient-reported outcomes (e.g., qDASH scores)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
| Device,equipment |
Interventions/Control_1
Intervention group:
Standard care plus extracorporeal shock wave therapy (ESWT)
Interventions/Control_2
Control group:
Standard care alone
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients with unilateral frozen shoulder aged over 40 years
2. Patients who have undergone medical history review, physical examination, X-ray examination, and ultrasound examination
3. Patients presenting with pain and restricted shoulder joint range of motion
(Flexion < 140 degree, External rotation < 30 degree, Internal rotation < L1 level)
4. Patients showing no abnormal findings in the shoulder joint on X-ray and ultrasound examinations
Key exclusion criteria
1. Presence of rotator cuff tears or calcification
2. Bilateral shoulder involvement
3. Previous surgical interventions in the neck or shoulder region
4. History of fractures or injuries around the shoulder joint
5. Presence of neurological dysfunction
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Koshi |
| Middle name | |
| Last name | Shimizu |
Organization
Keyaki Clinic
Division name
Department of Rehabilitation
Zip code
921-8064
Address
5-451 Yokaichi, Kanazawa, Ishikawa, 921-8064, Japan
TEL
076-240-2155
k4mizu@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Koshi |
| Middle name | |
| Last name | Shimizu |
Organization
Keyaki Clinic
Division name
Department of Rehabilitation
Zip code
921-8064
Address
5-451 Yokaichi, Kanazawa, Ishikawa, 921-8064, Japan
TEL
076-240-2155
Homepage URL
k4mizu@hotmail.co.jp
Sponsor or person
Institute
Keyaki Clinic
Institute
Department
Personal name
Koshi Shimizu
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Faculty of Health and Medical Sciences, Hokuriku University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Committee of Hokuriku University
Address
1-1 Taiyogaoka, Kanazawa, Ishikawa, Japan
Tel
076-229-6111
syakairenkei@hokuriku-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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2027 | Year | 03 | 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 | 01 | Month | 05 | Day |
Last modified on
| 2026 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067433
