UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007105
Receipt number R000008368
Scientific Title Evaluation for the analgesic effects of RACZ catheter treatment on intractable chronic pain patients
Date of disclosure of the study information 2012/02/01
Last modified on 2023/10/10 09:52:15

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Basic information

Public title

Evaluation for the analgesic effects of RACZ catheter treatment on intractable chronic pain patients

Acronym

Evaluation for the analgesic effects of RACZ catheter treatment on intractable chronic pain patients

Scientific Title

Evaluation for the analgesic effects of RACZ catheter treatment on intractable chronic pain patients

Scientific Title:Acronym

Evaluation for the analgesic effects of RACZ catheter treatment on intractable chronic pain patients

Region

Japan


Condition

Condition

intractable chronic lumbargo and lower extrimity pain

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation for the analgesic effects of RACZ catheter treatment on intractable chronic pain patients

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

pain score

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

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

RACZ catheter treatment

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

intractable chronic lumbargo and lower extrimity pains

Key exclusion criteria

malignancy
antiplatelet, anticoagulant,
bleeding tendency
mental disease
impaired liver and renal function
allergies to drugs

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takasumi Katoh

Organization

Hamamatu University School of Medicine Hospital

Division name

Anesthesiology

Zip code


Address

1-20-1 handayama higashiku Hamamatu

TEL

053-435-2111

Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Hamamatu University School of Medicine

Division name

Anesthesiology

Zip code


Address


TEL


Homepage URL


Email



Sponsor or person

Institute

Hamamatu University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Hamamatu University School of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

浜松医科大学医学部附属病院(静岡県)


Other administrative information

Date of disclosure of the study information

2012 Year 02 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


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

2012 Year 01 Month 15 Day

Date of IRB

2011 Year 09 Month 09 Day

Anticipated trial start date

2012 Year 02 Month 01 Day

Last follow-up date

2015 Year 01 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 01 Month 20 Day

Last modified on

2023 Year 10 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008368


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name