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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040546
Receipt No. R000046214
Scientific Title Application and efficacy of percutaneous caudal epidural lysis of adhesions and neuroplasty with isobaric solution in 100 cases.a single center. retrospective obserbation study.
Date of disclosure of the study information 2020/06/14
Last modified on 2020/05/27

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Basic information
Public title Application and efficacy of percutaneous caudal epidural lysis of adhesions and neuroplasty with isobaric solution in 100 cases.
Acronym Application and efficacy of percutaneous caudal epidural lysis of adhesions and neuroplasty with isobaric solution in 100 cases.
Scientific Title Application and efficacy of percutaneous caudal epidural lysis of adhesions and neuroplasty with isobaric solution in 100 cases.a single center. retrospective obserbation study.
Scientific Title:Acronym Application and efficacy of percutaneous casdal epidural lysis of adhesions and neuroplasty with isobaric solution in 100 cases.
Region
Japan

Condition
Condition Low back pain patients (adults)
Classification by specialty
Anesthesiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to examine the effect of percutaneous caudal epidural adhesions and neuroplasty with isobaric solution for the low back pain patients with or without the lumbar surgery.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Efficacy evaluation: Neumerous rating scale of low back pain before the percutaneous caudal epidural lysis and neuroplasty with isobaric solution.
Neumerous rating scale of low back pain before the percutaneous epidural lysis 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.Low back pain patients who were resistant for the conservative pain control therapy.
2.Japanese males and femailes 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 did not receive the percutaneous caudal epidural lysis of adhesions and neuroplasty with isobaric solution.
Target sample size 100

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
Email 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 +81113855151
Homepage URL
Email kota64998@gmail.com

Sponsor
Institute Ebetsu city hospital
department of painclinic and anesthesia
Institute
Department

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
Email 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 14 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 05 Month 15 Day
Date of IRB
Anticipated trial start date
2020 Year 08 Month 15 Day
Last follow-up date
2020 Year 09 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To aim the apprecation and efficacy of the percutaneous sacral epidural lysis of adhesions and neuroplasty for isobaric solution in 100 cases.We divided into 2 groups. Group1 was low back pain patients with spinal surgery.(N=32)Group2 was low back pain patients without spinal surgery.(N=68)We assessed primary outcome measures in the NRS(Numerous rating scale) of low back pain before and 24 hours after the treatment.Comparisons were made by using Wilcoxon signed rank test. In group1, the mean baseline NRS , and the mean NRS 24hours after the treatment were 8.2
(S.D 0.5),3.5(S.D 1.6),respectively. The mean baseline NRS , and the mean NRS 24hours after the treatment were 8.0
(S.D 0.7), 3.0(S.D 1.6), respectively in group 2.Among the patients, we detected significant improvement in NRSpain scole 24hours after the treatment compared with the baseline NRS. The percutaneous caudal epidural lysis of adhesions and neuroplasty with isobaric solution is effective for low back pain patients due to sacral epidural adhesions with or without spinal surgery.


Management information
Registered date
2020 Year 05 Month 27 Day
Last modified on
2020 Year 05 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046214

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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