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Name
UMIN ID

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000048560
Receipt No. 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 2022/08/03

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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 50

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
Email 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
Email ccpa0908@chiba-u.jp

Sponsor
Institute Graduate School of Medicine Chiba University.
Institute
Department

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
Email 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
2022 Year 08 Month 03 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055329

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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