UMIN-CTR Clinical Trial

Public title

Assessing the therapeutic effectiveness of the bumpy patch for knee pain: a randomized controlled clinical trial.

Acronym

Assessing the therapeutic effectiveness of the bumpy patch for knee pain: a randomized controlled clinical trial.

Scientific Title

Assessing the therapeutic effectiveness of the bumpy patch for knee pain: a randomized controlled clinical trial.

Scientific Title:Acronym

Assessing the therapeutic effectiveness of the bumpy patch for knee pain: a randomized controlled clinical trial.

Region

Japan

Condition

Chronic knee pain (for those with pain for more than 6 months)

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

In this study, RCT test and VAS measurement were performed to compare the pain relief effect of patients with chronic knee pain with pseudo patch non-convex group (sham) and convex real patch randomly (alternately).

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

VAS pain relief rate measurement and verification of placebo effect by RCT
Pain relief measurement of sham patch and developed bumpy patch for patients with chronic knee pain will be performed.

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

10

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Maneuver

Interventions/Control_1

Analgesic relief is measured using sham and bump patches.

Interventions/Control_2

Period: 2019/6/1~2019/9/30

Interventions/Control_3

Application time (treatment time):
Sham patch group 1 minute
Bumpy patch group 1 min
Paste them alternately.

Interventions/Control_4

Break time: With sham patches
Between bumpy patches
Take a break of 15 minutes.

Interventions/Control_5

Number of sheets to be attached: 1 person 10 to 20 sheets of BP attached Use 1 to 2 sheets of SP sheet. Use the same number of fake patches

Interventions/Control_6

Number of treatments: Apply twice (sham patch & bumpy patch) alternately per person.

Interventions/Control_7

114 chronic patients are the patients to be measured. Chronic disability was defined as pain lasting 6 months or longer. The measured joint dysfunction of the patient is a joint dysfunction of the upper limb, the lower back and the lower limb. There are 26 with upper limb joint disorders, 38 with lumbar joint disorders, and 50 with lower limb joint disorders. Upper limb joint disorders mainly involve shoulder disorders, but also include neck and elbow joint disorders.

Interventions/Control_8

Of 114 people, 46 were selected as a result of unlisted subjects with knee pain. However, because the data for 3 of them was ambiguous, the data for 43 was organized and summarized in a paper.

Interventions/Control_9

This is a summary of the contents of part of chronic knee pain presented at the 40th Japan Society for Chronic Pain. It was also presented at the International Society of Biomechanics (ISB 2011).

Interventions/Control_10

Zero pain relief in the lower limbs, including upper limbs, hips, hips, and buttocks, and zero efficacy in 114 patients, zero pain rate 75.4%
The effective rate was 100%.

Age-lower limit

14

years-old

<=

Age-upper limit

79

years-old

>=

Gender

Male and Female

Key inclusion criteria

From the time of approval of the Ethics Review Committee until July 28, 2013-February 28, 2014, physiotherapy was prescribed at Orthopedic Surgery at Seisen Clinic, and consent was obtained for this study.
The subjects had pain for more than 6 months.

Key exclusion criteria

I can't communicate. Also, it is a case where it is difficult to measure physical activity due to cognitive decline.

Communication in the test is the ability to transmit internal information of the body as appropriate because pain is unique,
and it relates to the degree of pain reduction and movement of pain.

Target sample size

43

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

410-0057

Address

Shizuoka Prefecture Numazu City Takazawa Town 3-15 Japan

TEL

+81559264771

Homepage URL

Email

ryu9ten7@yahoo.co.jp

Institute

smj co ltd

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

National University of Electro-Communications Graduate School of Informatics Ethics Committee

Address

1-5-1 Chofugaoka, Chofu-shi, Tokyo

Tel

+81559811936

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

Date of disclosure of the study information

2020

Year

07

Month

15

Day

URL releasing protocol

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

Publication of results

Published

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

43

Results

One-way ANOVA followed by Bonferroni Ppost-hoc tests showed significant difference between baseline patching and bumpy patching (p <0.001) and baseline and sham patching (p <0.001) Became clear. In contrast to group A, no statistical significance was found between the application of the bumpy patch and the sham patch of group B. Subsequent fake patching could not lower the NRS score below that after the bumpy patching.

Results date posted

2020

Year

07

Month

13

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2014

Year

11

Month

01

Day

Baseline Characteristics

Subject is a holder of pain for more than 6 months. The age range was from 14 to 79 years and 114 men and women were used. The average pain index by VAS was 60-62 (AB group).
Published in Japanese Journal of Chronic Pain VOL32.No1.2013.217p

The data used in this paper are based on unpublished knee pain data.

Participant flow

The subjects were more than 400 patients per day, and the subjects were prescribed physiotherapy to a doctor. The test was randomly selected from these.

The total pain relief rate of 114 subjects was 100%, of which 75.4% (86) had zero pain experience. In fact, 86 out of 114 subjects are completely free of pain.

Adverse events

After applying AA, some people had redness and rash. None of the subjects had increased pain due to AA sticking, but many experienced pain transfer shortly after using AA.
The pain disappears immediately after using AA, the recovery rate of the treated area is high, and the painful areas appear one after another as a characteristic of chronic pain. A survey of these rates one month later revealed that 8 out of 43 patients complained of pain in the same area, 15 had pain migration, and 20 did not feel pain. It was

Outcome measures

Data from VAS measurements and RCT tests were analyzed statistically by the SPSS statistical software package.
(Windows IBM SPSS ver22). Statistical significance is p
It was set to <0.05.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2013

Year

06

Month

28

Day

Date of IRB

2013

Year

06

Month

28

Day

Anticipated trial start date

2013

Year

07

Month

01

Day

Last follow-up date

2014

Year

02

Month

18

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2020

Year

07

Month

13

Day

Last modified on

2020

Year

07

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046711