![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
![]() |
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 |
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 |
|
Condition | ||
Condition | Lumbar spinal canal stenosis, lumbar spondylolisthesis, lumbar disc herniation | |
Classification by specialty |
|
|
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
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 |
|
||||||
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 | |
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 |
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 |
|
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 |
|
||||||
Date of IRB |
|
||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | observational study |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
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 |