UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045031 |
|---|---|
| Receipt number | R000051433 |
| Scientific Title | Evaluation of the effect of self-care goods using vibration stimulation after non-surgical shoulder joint mobilization - A randomized controlled trial |
| Date of disclosure of the study information | 2021/08/01 |
| Last modified on | 2023/08/02 09:46:04 |
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Basic information
Public title
Evaluation of the effect of self-care goods using vibration stimulation after non-surgical shoulder joint mobilization - A randomized controlled trial
Acronym
Evaluation of the effect of self-care goods using vibration stimulation after non-surgical shoulder joint mobilization - A randomized controlled trial
Scientific Title
Evaluation of the effect of self-care goods using vibration stimulation after non-surgical shoulder joint mobilization - A randomized controlled trial
Scientific Title:Acronym
Evaluation of the effect of self-care goods using vibration stimulation after non-surgical shoulder joint mobilization - A randomized controlled trial
Region
| Japan |
Condition
Condition
Flozen shoulder
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to verify whether self-care with vibration stimulation is effective in improving shoulder range of motion and pain in patients after non-surgical shoulder mobilization.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)Range of motion of shoulder joint
2) JOA score
3) Pain (VAS)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are 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
In addition to the self-exercises instructed by the physiotherapist in charge, massage using vibration stimulation is performed once a day. The massage should be performed on the anterior chest, axilla, trapezius, and upper arm for 120 seconds each.
Interventions/Control_2
Instruct the patient to perform self-exercises once a day as instructed by the physical therapist in charge.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients undergoing outpatient rehabilitation after non-surgical shoulder joint mobilization
2) Patients aged 20 years or older. Regardless of gender
3) Patients who were able to answer the patient-reported outcome survey
Key exclusion criteria
1) Patients with a rotator cuff tear confirmed by preoperative echo or MRI
2) Patients who are unable to give consent to the research
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Isaji |
Organization
Anshin clinic
Division name
rehabiritation
Zip code
6510095
Address
City Tower Plaza 4F, 4-1-4 Asahidori, Chuo-ku, Kobe
TEL
0782515959
yisaji617@gmail.com
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Isaji |
Organization
Anshin clinic
Division name
rehabiritation
Zip code
6510095
Address
City Tower Plaza 4F, 4-1-4 Asahidori, Chuo-ku, Kobe
TEL
0782515959
Homepage URL
yisaji617@gmail.com
Sponsor or person
Institute
Anshin 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
Anshin clinic
Address
City Tower Plaza 4F, 4-1-4 Asahidori, Chuo-ku, Kobe
Tel
0782515959
yisaji617@gmail.com
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
| 2021 | Year | 08 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2021 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2022 | 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
| 2021 | Year | 08 | Month | 01 | Day |
Last modified on
| 2023 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051433
