UMIN-CTR Clinical Trial

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