UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041083 |
|---|---|
| Receipt number | 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 10:27:40 |
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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.
Region
| Japan |
Condition
Condition
Chronic knee pain (for those with pain for more than 6 months)
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Assessment
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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%.
Eligibility
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
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
410-0057
Address
Shizuoka Prefecture Numazu City Takazawa Town 3-15 Japan
TEL
+81559264771
Homepage URL
ryu9ten7@yahoo.co.jp
Sponsor or person
Institute
smj co ltd
Institute
Department
Personal name
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
National University of Electro-Communications Graduate School of Informatics Ethics Committee
Address
1-5-1 Chofugaoka, Chofu-shi, Tokyo
Tel
+81559811936
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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 15 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-bin/ctr/ctr_up_rec_f5.cgi
Publication of results
Published
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
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
Progress
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046711
