UMIN-CTR Clinical Trial

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

Athlete's injury (injury, trauma) general parts

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

SMJ Co LTD



Manipulative department

Institute

Department

Personal name

Organization

University of Electro-Communications

Department of Informatics Mito Lab

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東海整骨院(静岡県)

Date of disclosure of the study information

2020

Year

12

Month

30

Day

URL releasing protocol

https://upload.umin.ac.jp/cgi-bin/ctr/ctr_up_rec_f5.cgi

Publication of results

Unpublished

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

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 related information

Registered date

2020

Year

12

Month

20

Day

Last modified on

2020

Year

12

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046936