UMIN-CTR Clinical Trial

Public title

Evaluation of the therapeutic results of percutaneous adhesiolysis using Racz catheter for chronic refractory pain

Acronym

Evaluation of the therapeutic results of percutaneous adhesiolysis using Racz catheter

Scientific Title

Evaluation of the therapeutic results of percutaneous adhesiolysis using Racz catheter for chronic refractory pain

Scientific Title:Acronym

Evaluation of the therapeutic results of percutaneous adhesiolysis using Racz catheter

Region

Japan

Condition

chronic refractory pain

Classification by specialty

Orthopedics

Anesthesiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

We performe adhesiolys of insertion of a Racz catheter and in vestigate whether differences in the locations of adhesiolysis in the epidural space contributed to the outcomes of pain relief in chronic refractory pain

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Visual analogue scale(VAS),The Roland-Morris Disability Questionnaire,The Oswestry Disability Index 2.0,Japanese Orthopedic Association back pain treatment results evaluation criteria

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

All patients are investigated whether differences in the locations of adhesiolysis contributed to the outcomes of pain relief.In accordance with the findings of the fluoroscopic imaging, the patients who have adhesions of the epidural space are divided into the adhesiolysis of the epidural space group (E group)

Interventions/Control_2

All patients are investigated whether differences in the locations of adhesiolysis contributed to the outcomes of pain relief.In accordance with the findings of the fluoroscopic imaging, the patients who have adhesions of the nerve root are divided into the adhesiolysis of the nerve root group (R group).

Interventions/Control_3

All patients are investigated whether differences in the locations of adhesiolysis contributed to the outcomes of pain relief.In accordance with the findings of the fluoroscopic imaging, the patients who have adhesions of both the epidural space and the nerve root are divided into the adhesiolysis of both the epidural space and the nerve root group (ER group).

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

Patients in whom the symptoms could not be sufficiently improved by conservative therapies, such as nerve blockade, oral medications with non-steroidal anti-inflammatory drugs or physical therapy, and patients in whom the symptoms could not be sufficiently imptover by surgical therapy. In all patients, fluoroscopic imaging using a contrast medium(10ml;OMNIPAQUE240) are performed to assess the condition of adhesion.All patients have adhesions in the locations of attributed to the pain.

Key exclusion criteria

Patients with hemorrhagic tendencies, psychiatric abnormalities or malignant diseases or severe liver disease or severe renal disease or drug allergy were also excluded from the study

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Junji Takatani

Organization

Oita University Faculty of Medicine

Division name

Department of Anesthesiology and Intensive Care Medicine

Zip code

Address

1-1 Idaigaoka, Hasama, Oita, 879-5593, Japan

TEL

Email

Name of contact person

1st name
Middle name
Last name	Junji Taktani

Organization

Oita University Faculty of Medicine

Division name

Department of Anesthesiology and Intensive Care Medicine

Zip code

Address

1-1 Idaigaoka, Hasama, Oita, 879-5593, Japan

TEL

Homepage URL

Email

Institute

Oita University Faculty of Medicine, Department of Anesthesiology and Intensive Care Medicine

Institute

Department

Personal name

Organization

Oita University Faculty of Medicine, Department of Anesthesiology and Intensive Care Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

大分大学附属病院（大分県）

Date of disclosure of the study information

2010

Year

04

Month

02

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

Enrolling by invitation

Date of protocol fixation

2010

Year

04

Month

01

Day

Date of IRB

Anticipated trial start date

2010

Year

04

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

04

Month

02

Day

Last modified on

2012

Year

03

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004129