UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040500 |
|---|---|
| Receipt number | R000046204 |
| Scientific Title | The efficacy of percutaneous epidural adhesions and neuroplasty with isobaric solution for the failed back surgery syndrome.a single center. retrospective observation study. |
| Date of disclosure of the study information | 2020/06/07 |
| Last modified on | 2020/05/25 14:07:04 |
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Basic information
Public title
The efficacy of percutaneous epidural adhesions and neuroplasty with isobaric solution for the failed back surgery syndrome.
Acronym
The efficacy of percutaneous epidural adhesions and neuroplasty with isobaric solution for the failed back surgery syndrome.
Scientific Title
The efficacy of percutaneous epidural adhesions and neuroplasty with isobaric solution for the failed back surgery syndrome.a single center.
retrospective observation study.
Scientific Title:Acronym
The efficacy of percutaneous epidural adhesions and neuroplasty with isobaric solution for the failed back surgery syndrome.
Region
| Japan |
Condition
Condition
Failed back surgery syndrome (adults)
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to examine effect of percutaneous epidural lysis of adhesions and neuroplasty with isobaric solution for the failed back surgery syndrome with or without instrumental fixation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy evaluations: Numerous rating scale of numbness and low back pain before the percutaneous epidural lysis of adhesions and neuroplasty with isobaric solution.
Numerous rating scale of numbness and low back pain 24hours after the percutaneous epidural lysis of adhesions and neuroplasty with isobaric solution.
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Failed back surgery syndrome without spinal cord damage.
2.Japanese males and females aged over 20 years old.
3. Indivisuals whose written informed consent has been obtained .
4. Indivisuals judged appropriate for the study by the principal.
Key exclusion criteria
1. Indivisuals with spinal cord dameged.
2. Indivisuals did not receive the percutaneous epidural lysis of adhesions and neuroplasty with isobaric solution.
Target sample size
21
Research contact person
Name of lead principal investigator
| 1st name | koichi |
| Middle name | |
| Last name | ota |
Organization
Ebetsu city hospital
Division name
department of painclinic and anesthesia
Zip code
067-8585
Address
6wakakusa-chyou ebetsu
TEL
+81113855151
kota64998@gmail.com
Public contact
Name of contact person
| 1st name | koichi |
| Middle name | |
| Last name | ota |
Organization
Ebetsu city hospital
Division name
department of painclinic and anesthesia
Zip code
067-8585
Address
6wakakusa-chyou ebetsu
TEL
+81113825151
Homepage URL
kota64998@gmail.com
Sponsor or person
Institute
Ebetsu city hospital
department of painclinic and anesthesia
Institute
Department
Personal name
Funding Source
Organization
Ebetsu city hospital
department of painclinic and anesthesia
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
IRB of ebetsu city hospital
Address
6wakakusa-chyou ebetsu
Tel
+81113825151
hos-kanri@city.ebetsu.lg.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
江別市立病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 07 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 04 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To aim the effect of percutaneous epidural lysis of adhesions and neuroplasty with isobaric solusion for 21 cases of the failed back surgery syndrome.
The percutaneous epidural lysis of adhesions and neuroplasty with isobaric solusion decreased significantly numbness and low back pain 24 hours after the treatment for the failed back surgery syndrome with or without posterior limbar interbody fusion.
The percutaneous epidural lysis of adhesions and neuroplasty with isobaric solusion is useful therapy for the failed back surgery syndrome.
Management information
Registered date
| 2020 | Year | 05 | Month | 23 | Day |
Last modified on
| 2020 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046204
