UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025198
Receipt number R000028924
Scientific Title Examination about the analgesic effect of adhesiolysis with Racz catheter for chronic and intractable spinal pain
Date of disclosure of the study information 2017/01/01
Last modified on 2022/06/13 20:52:57

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Basic information

Public title

Examination about the analgesic effect of adhesiolysis with Racz catheter for chronic and intractable spinal pain

Acronym

Examination about the analgesic effect of adhesiolysis with Racz catheter for chronic and intractable spinal pain

Scientific Title

Examination about the analgesic effect of adhesiolysis with Racz catheter for chronic and intractable spinal pain

Scientific Title:Acronym

Examination about the analgesic effect of adhesiolysis with Racz catheter for chronic and intractable spinal pain

Region

Japan


Condition

Condition

Failed back surgery syndrome, disc hernia, neck and lumbar spinal canal stenosis,and degenerative spondylosis to be resistant to conservative treatment and surgical treatment

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation the effect of adhesiolysis with Racz catheter against conventional treatment

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Establishment of the epidural adhesiolysis for the patients with failed back surgery syndrome, lumber disc hernia, neck and lumbar spinal canal stenosis, and degenerative spondylosis to be resistant

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine Maneuver

Interventions/Control_1

We record pain score (NRS, VAS), the Japanese Orthopedics Association Back Pain Evaluation Questionnaire(JOABPQ), EQ-5D.
We record it before treatment , next day ,4 weeks,12 weeks, 24 weeks after treatment.
We record medicine, blood pressure, pulse, a few days before treatment,next day,4 weeks,12 weeks,24 weeks after treatment.
Epidurography : before treatment, next day,12 weeks after treatment.
We perform whether patients meet exclusion criteria as a screening 1-4 weeks before treatment.
We record an adverse from 1-3 days before treatment to 24 weeks after treatment,when it happenned.

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

The patients with failed back surgery syndrome, disc hernia, neck and lumbar spinal canal stenosis, degenerative spondylosis to be resistant to conservative treatment and surgical treatmentand furthermore, the patients performed epidurography using contrast media,with defect the epidural space and nerve root of the pain site.

Key exclusion criteria

(1)The patients during an antiplatelet drug, and anticoagulant drug (who are available for discontinuation are excluded), the patients with the bleeding tendency
(2) The patients with the mental disorder
(3) The patients with malignant disorder
(4) The patients with serious liver and renal dysfunction
(5) Is the patients of the drug irritable diathesis such as allergies with a use drug
(6) A pregnant woman or the patients with desire for pregnancy
(7)In addition, the patients who the doctor attending of this study judged as an inadequate case

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Toshiaki
Middle name
Last name Minami

Organization

Osaka medical college

Division name

Department of anesthesiology

Zip code

5690088

Address

2-7 Daigaku-machi,Takatsuki,Osaka,JAPAN

TEL

072-683-1221

Email

ane022@osaka-med.ac.jp


Public contact

Name of contact person

1st name Kenji
Middle name
Last name Morimoto

Organization

Osaka medical college

Division name

Department of anesthesiology

Zip code

569--0088

Address

2-7 Daigaku-machi,Takatsuki,Osaka,JAPAN

TEL

072-683-1221

Homepage URL


Email

ane046@osaka-med.ac.jp


Sponsor or person

Institute

Osaka medical college

Institute

Department

Personal name



Funding Source

Organization

Osaka medical college

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

Osaka medical college

Address

2-7 Daigaku-machi,Takatsuki,Osaka,JAPAN

Tel

072-683-1221

Email

ane046@osaka-med.ac.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

2017 Year 01 Month 01 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

0

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

Terminated

Date of protocol fixation

2016 Year 11 Month 07 Day

Date of IRB

2016 Year 11 Month 07 Day

Anticipated trial start date

2016 Year 11 Month 07 Day

Last follow-up date

2021 Year 06 Month 14 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 12 Month 09 Day

Last modified on

2022 Year 06 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028924


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name