UMIN-CTR Clinical Trial

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

Low back pain patients (adults)

Classification by specialty

Anesthesiology

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Ebetsu city hospital
department of painclinic and anesthesia

Institute

Department

Personal name

Organization

Ebetsu city hospital
department of painclinic and anesthesia

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

IRB of ebetsu city hospital

Address

6wakakusa-chyou ebetsu

Tel

+81113825151

Email

hos-kanri@city.ebetsu.lg.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

江別市立病院（北海道）

Date of disclosure of the study information

2020

Year

06

Month

14

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2020

Year

05

Month

27

Day

Last modified on

2020

Year

05

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046214