UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037917 |
|---|---|
| Receipt number | R000043219 |
| Scientific Title | Effects of discomfort caused by sensorimotor incongruence on acute pain |
| Date of disclosure of the study information | 2019/10/01 |
| Last modified on | 2023/03/07 22:56:09 |
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Basic information
Public title
Effects of discomfort caused by sensorimotor incongruence on acute pain
Acronym
sensorimotor incongruence and acute pain
Scientific Title
Effects of discomfort caused by sensorimotor incongruence on acute pain
Scientific Title:Acronym
sensorimotor incongruence and acute pain
Region
| Japan |
Condition
Condition
Upper and lower limb fractures
Classification by specialty
| Orthopedics | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of sensorimotor incongruence on pain
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain intensity 2 weeks and 1 month after fracture
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
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Flexion and extension exercises using a mirror every two weeks
Interventions/Control_2
Flexion and extension movements of the extremities using a mirror in an incongruence state. This is also done every two weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Upper and kower limb fracture
Key exclusion criteria
bilateral fracture
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Matsuda |
| Middle name | |
| Last name | Soichiro |
Organization
Kio university
Division name
Graduate School of Health Science
Zip code
635-0832
Address
4-2-2 Umaminaka, Hiroryo-cho, Kitatsukagi-gun, Nara Prefecture
TEL
0745-54-1601
chocobaby.0802.26@gmail.com
Public contact
Name of contact person
| 1st name | Osumi |
| Middle name | |
| Last name | Michihiro |
Organization
Kio university
Division name
Graduate School of Health Science
Zip code
635-0832
Address
4-2-2 Umaminaka, Hiroryo-cho, Kitatsukagi-gun, Nara Prefecture
TEL
0745-54-1601
Homepage URL
m.ohsumi@kio.ac.jp
Sponsor or person
Institute
Kio university
Institute
Department
Personal name
Funding Source
Organization
Kio university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kio university
Address
4-2-2 Umaminaka, Hiroryo-cho, Kitatsukagi-gun, Nara Prefecture
Tel
0745-54-1601
chocobaby.0802.26@gmail.com
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
| 2019 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
No data
Publication of results
Unpublished
Result
URL related to results and publications
No data
Number of participants that the trial has enrolled
18
Results
Heaviness caused by sensorimotor incongruence may cause pain prolongation. Accordingly, attention should be paid to patients with acute musculoskeletal pain who present with heaviness.
Results date posted
| 2022 | Year | 03 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients within 2 months after fracture (excluding fractures around the shoulder and hip joints) were included in the study.
Participant flow
In the congruent condition, patients were asked to perform flexion-extension exercises on the healthy and affected side at the same time. In the incongruent condition, patients were asked to perform flexion-extension exercises on the healthy and affected side at different time. The congruent and incongruent conditions were performed for 20 seconds.
Adverse events
Sensorimotor incongruence may exacerbate pain.
Outcome measures
patients were asked to answer a questionnaire about abnormal perception (pain, discomfort, peculiarity, heaviness, temperature change, extra limb, lost limb (Brun et al, 2019) on a 7-point Likert scale.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 03 | Day |
Last modified on
| 2023 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043219
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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