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Recruitment status Completed
Unique ID issued by UMIN UMIN000041083
Receipt No. R000046711
Scientific Title Assessing the therapeutic effectiveness of the bumpy patch for knee pain: a randomized controlled clinical trial.
Date of disclosure of the study information 2020/07/15
Last modified on 2020/07/13

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Basic information
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.

Condition Chronic knee pain (for those with pain for more than 6 months)
Classification by specialty
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

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Dynamic allocation
Institution consideration

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

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

Public contact
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

Institute smj co ltd

Funding Source
Organization University of Electro-Communications

Department of Informatics Mito Lab

Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Name of secondary funder(s)

IRB Contact (For public release)
Organization National University of Electro-Communications Graduate School of Informatics Ethics Committee
Address 1-5-1 Chofugaoka, Chofu-shi, Tokyo
Tel +81559811936

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2


Other administrative information
Date of disclosure of the study information
2020 Year 07 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

URL related to results and publications
Number of participants that the trial has enrolled 43
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

Management information
Registered date
2020 Year 07 Month 13 Day
Last modified on
2020 Year 07 Month 13 Day

Link to view the page

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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