UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048560 |
|---|---|
| Receipt number | R000055329 |
| Scientific Title | A study of infrared thermographic changes before and after therapeutic intervention in neuropathic pain. |
| Date of disclosure of the study information | 2022/08/03 |
| Last modified on | 2023/06/09 07:06:22 |
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Basic information
Public title
A study of infrared thermographic changes before and after therapeutic intervention in neuropathic pain.
Acronym
A study of infrared thermographic changes before and after therapeutic intervention in neuropathic pain.
Scientific Title
A study of infrared thermographic changes before and after therapeutic intervention in neuropathic pain.
Scientific Title:Acronym
A study of infrared thermographic changes before and after therapeutic intervention in neuropathic pain.
Region
| Japan |
Condition
Condition
Lumbar spinal canal stenosis, lumbar spondylolisthesis, lumbar disc herniation
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to perform thermographic testing on patients with lower extremity neuropathic pain due to lumbar spine lesions before and after treatment and to determine if this testing can be used to determine the effectiveness of treatment for neuropathic pain.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of temperature differences between the healthy and affected side before and after treatment.(Post-intervention is defined as 2 to 6 weeks after the start of treatment)
Key secondary outcomes
Correlation between temperature difference between healthy and affected side and pain VAS
Correlation between temperature difference between healthy and affected side and numbness VAS
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with leg pain who visited orthopedic department in our hospital
Key exclusion criteria
Patients with a diagnosis of arteriosclerosis obliterans of the lower extremities
Patients using Ca channel alpha 2 delta ligand within 1 week
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroto |
| Middle name | |
| Last name | Chikubu |
Organization
Graduate School of Medicine Chiba University.
Division name
Anesthesiology
Zip code
260-8677
Address
Inohana1-8-1,Chuo-ku,Chiba-shi,Chiba
TEL
0432227171
ccpa0908@chiba-u.jp
Public contact
Name of contact person
| 1st name | Hiroto |
| Middle name | |
| Last name | Chikubu |
Organization
Graduate School of Medicine Chiba University.
Division name
Anesthesiology
Zip code
260-8677
Address
Inohana1-8-1,Chuo-ku,Chiba-shi,Chiba
TEL
0432227171
Homepage URL
ccpa0908@chiba-u.jp
Sponsor or person
Institute
Graduate School of Medicine Chiba University.
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Graduate School of Medicine Chiba University.
Address
Inohana1-8-1,Chuo-ku,Chiba-shi,Chiba
Tel
0432227171
ccpa0908@chiba-u.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
| 2022 | Year | 08 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
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
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 05 | Month | 23 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2022 | Year | 08 | Month | 03 | Day |
Last modified on
| 2023 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055329
