UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050611 |
|---|---|
| Receipt number | R000054217 |
| Scientific Title | Effects of radiofrequency irradiation of the periscapular muscles of patients with subjective shoulder stiffness symptoms on muscle hardness and subjective stiffness intensity of the same muscles |
| Date of disclosure of the study information | 2023/03/16 |
| Last modified on | 2024/12/16 19:17:57 |
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Basic information
Public title
Effects of radiofrequency irradiation of the periscapular muscles of patients with subjective shoulder stiffness symptoms on muscle hardness and subjective stiffness intensity of the same muscles
Acronym
Effects of radiofrequency irradiation on shoulder stiffness and muscle stiffness
Scientific Title
Effects of radiofrequency irradiation of the periscapular muscles of patients with subjective shoulder stiffness symptoms on muscle hardness and subjective stiffness intensity of the same muscles
Scientific Title:Acronym
Effect of radiofrequency irradiation of periscapular muscles on muscle hardness and subjective shoulder stiffness intensity
Region
| Japan |
Condition
Condition
Neck/shoulder discomfort
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the immediate effectiveness of ColiCoran in improving shoulder stiffness based on the amount of change in subjective shoulder stiffness intensity and the amount of change in muscle hardness at the site of radiofrequency irradiation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Comparison of change in muscle hardness before and after wearing CoriCoran with that of the dummy and this product
Key secondary outcomes
Comparison of NRS change before and after Coricoran installation with dummy installation and with this product
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Eight Colicorans (dummy), which does not emit high frequency, is worn for 5 hours.
Interventions/Control_2
Eight ColiCorans that emit high frequency are worn for 5 hours.
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(i) Those who are at least 18 years old and less than 30 years old at the time of obtaining consent.
(ii) Have no history of orthopedic disease or surgery on the shoulder joint or surrounding muscles and ligaments other than shoulder stiffness
(iii) Persons who can give written consent to participate in this study
(iv) Those who have shoulder stiffness of 2 or greater intensity on the NRS at the time consent is obtained.
Key exclusion criteria
(i) Those who have a conflict of interest, such as the relationship between the person in charge of the research and the research subject being a faculty member and a student, and the student attending the lectures of the person in charge of the research.
(ii) Persons who have developed a skin rash from the adhesive tape (during the pre-confirmation stage)
(iii) Pregnant women or those who may become pregnant
(iv) Persons who are using implanted medical electrical equipment such as pacemakers or wearable medical electrical equipment such as electrocardiographs
(v) Persons who fall under any of the precautions listed in the instruction manual that "require consultation with a physician upon use" (acute illness, malignant tumor, skin disease, anemia, peripheral nerve disorder, menstruation, pregnancy)
(6) Other persons who are deemed inappropriate by the principal investigator or research assistant.
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | Yukio |
| Middle name | |
| Last name | Urabe |
Organization
Hiroshima University
Division name
Graduate School of Biomedical and Health Sciences
Zip code
734-8553
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL
082-257-5410
norimmi@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Noriaki |
| Middle name | |
| Last name | Maeda |
Organization
Hiroshima University
Division name
Graduate School of Biomedical and Health Sciences
Zip code
734-8553
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL
082-257-5410
Homepage URL
norimmi@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Other
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
Ethical Committee for Clinical Research of Hiroshima University
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
Tel
082-257-1551
iryo-seisaku@office.hiroshima-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
| 2023 | Year | 03 | Month | 16 | 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
Main results already published
Date of protocol fixation
| 2022 | Year | 11 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 16 | Day |
Last modified on
| 2024 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054217
