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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042796
Receipt No. R000046936
Scientific Title Bumpy patches: analgesic effects of particle pressure in sports injury treatment
Date of disclosure of the study information 2020/12/30
Last modified on 2020/12/20

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Basic information
Public title Bumpy patches: analgesic effects of particle pressure in sports injury treatment
Acronym Bumpy patches: analgesic effects of particle pressure in sports injury treatment
Scientific Title Bumpy patches: analgesic effects of particle pressure in sports injury treatment
Scientific Title:Acronym Bumpy patches: analgesic effects of particle pressure in sports injury treatment
Region
Japan

Condition
Condition Athlete's injury (injury, trauma) general parts
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In this study, treatment was performed for the purpose of pain and recovery for all areas of injury and trauma caused by athletes' injuries. Using the newly designed particle pressure, NRS (Numerical Rating Scale) measurement was performed to set and compare the non-treated group and the treated group.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes NRS pain relief rate measurement in untreated and treated groups Numericalization from 100 to 0 was performed on 28 subjects.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 5
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 We investigated the analgesic effect and recovery of particle pressure using a newly designed treatment method for 28 subjects.
Interventions/Control_2 Period: 2020.11.4-12.15.
Interventions/Control_3 Number of treatments: 1 to 5 treatments were completed.
Interventions/Control_4 Treatment interval: continuous or within 3 days.
Interventions/Control_5 A comparison was made between the untreated group and the treated group.
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
14 years-old <=
Age-upper limit
44 years-old >=
Gender Male and Female
Key inclusion criteria Limited to sports injuries.

There are age restrictions

Being diagnosed by an orthopedic surgeon

Being injured within 6 months
Key exclusion criteria Injuries other than sports injuries.

There is an age limit (from junior high
school students to 48 years old working
adults There is).

Those who do not have an orthopedic
surgeon's diagnosis.

Injuries over 6 months are excluded.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Kazuyuki
Middle name
Last name Mito
Organization University of Electro-Communications
Division name Department of Informatics Mito Lab
Zip code 182-8585
Address 1-5-1 Chofugaoka, Chofu-shi, Tokyo
TEL +81424435554
Email k.mito@uec.ac.jp

Public contact
Name of contact person
1st name Norio
Middle name
Last name Saito
Organization smj co ltd
Division name Manipulative department
Zip code 4100057
Address Shizuoka Prefecture Numazu City Takazawa Town 3-15 Japan
TEL +819099333101
Homepage URL
Email smj2020@outlook.jp

Sponsor
Institute SMJ Co LTD



Manipulative department
Institute
Department

Funding Source
Organization University of Electro-Communications

Department of Informatics Mito Lab
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 University of Electro-Communications Department of Informatics Mito Lab
Address 1-5-1 Chofugaoka, Chofu-shi, Tokyo
Tel +81424435554
Email k.mito@uec.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 東海整骨院(静岡県)

Other administrative information
Date of disclosure of the study information
2020 Year 12 Month 30 Day

Related information
URL releasing protocol https://upload.umin.ac.jp/cgi-bin/ctr/ctr_up_rec_f5.cgi
Publication of results Unpublished

Result
URL related to results and publications https://upload.umin.ac.jp/cgi-bin/ctr/ctr_up_rec_f5.cgi
Number of participants that the trial has enrolled 28
Results The data analysis protocols and choices are summarized in Fig. 5. A total of 30 subjects were invited to the study, 30 enrolled, in which 2 were excluded (lack of data), and 28 subjects remained for the treatment study. The average VAS of the 28 subjects was 58.3. There were no significant differences in the NRS value (Table 1) between subject groups of different duration and part of the pain.
Five treatments were required until all subjects reported no pain (NRS = 0) and left the study (Fig. 5).
Results date posted
2020 Year 12 Month 20 Day
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 Open public recruiting
Date of protocol fixation
2020 Year 11 Month 04 Day
Date of IRB
2020 Year 11 Month 04 Day
Anticipated trial start date
2020 Year 11 Month 04 Day
Last follow-up date
2020 Year 12 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 12 Month 20 Day
Last modified on
2020 Year 12 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046936

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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