UMIN-CTR Clinical Trial

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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