UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008770
Receipt number R000010305
Scientific Title study of analgesic effect of cauda equina stimulation
Date of disclosure of the study information 2012/08/25
Last modified on 2012/08/25 21:53:01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

study of analgesic effect of cauda equina stimulation

Acronym

analgesic effect of cauda equina stimulation

Scientific Title

study of analgesic effect of cauda equina stimulation

Scientific Title:Acronym

analgesic effect of cauda equina stimulation

Region

Japan


Condition

Condition

Intractable pain of hip and limb

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Patrich Wall and Ronald Melzack introduce the gate control theory in 1965.Currently, as a treatment for patients with intractable pain, spinal cord stimulation therapy has been established as an effective treatment.Patients with intractable pain ,post-traumatic, post-operative peripheral neuropathy, postherpetic neuralgia, deafferentation painis, indicated for spinal cord stimulation therapy.For the success of spinal cord stimulation therapy, it is important that overlap irritation at the site of pain.But How to acquire a stable feeling of stimulation to the sacral nerve area has not been established.We will study whether it is possible to gain a sense of irritation stable sacral nerve area by stimulating the cauda equina nerve from L2 epidural space.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

getting stimulation feeling in sacral nerve area by cauda equina stimulation

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

Diagnosis

Type of intervention

Maneuver

Interventions/Control_1

Cauda equina nerve stimulation is performed by epidural puncture from L2 / 3.(for research) Electrode placement is performed to the position of the epidural irritation can be obtained at the site of pain.(for treatment)Each about 10 minutes and total takes about 20 minutes.

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

Patients with limb and/or hip intractable pain (post-herpetic neuralgia, disc herniation, lumbar spine vertebral disease, and peripheral neuropathic pain) , the resistant to medication and nerve block therapy, of admitted to the University Hospital in Kobe

Key exclusion criteria

1)Patient who do not agree the present reserch
2)Patient who is deemed inappropriate by attending doctor.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Fujio Yanamoto

Organization

Kobe University Graduate School of Medicine

Division name

Anesthesiology and Perioperative medicine

Zip code


Address

7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo Prefecture

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Masako Okada

Organization

Kobe University Graduate School of Medicine

Division name

Anesthesiology and Perioperative medicine

Zip code


Address

7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo Prefecture

TEL


Homepage URL


Email



Sponsor or person

Institute

Kobe University Graduate School of Medicine, Faculty of Medicine,
Department of Surgery Related, Division of Anesthesiology and Perioperative medicine

Institute

Department

Personal name



Funding Source

Organization

None

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


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



Other administrative information

Date of disclosure of the study information

2012 Year 08 Month 25 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

Open public recruiting

Date of protocol fixation

2012 Year 06 Month 11 Day

Date of IRB


Anticipated trial start date

2012 Year 08 Month 28 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 08 Month 25 Day

Last modified on

2012 Year 08 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010305


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name