UMIN-CTR Clinical Trial

Public title

Phase II trial of transcatheter arterial micro-embolization using imipenem/cilastatin sodium for refractory pain from tendinopathy and enthesopathy: Multicenter Study (INSTEP study)

Acronym

TAME: JMIS-1604 (INSTEP study)

Scientific Title

Phase II trial of transcatheter arterial micro-embolization using imipenem/cilastatin sodium for refractory pain from tendinopathy and enthesopathy: Multicenter Study (INSTEP study)

Scientific Title:Acronym

TAME: JMIS-1604 (INSTEP study)

Region

Japan

Condition

Chronic pain from tendinopathy and enthesopathy refractory to non-surgical management

Classification by specialty

Orthopedics

Radiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Phase II trial of transcatheter arterial micro-embolization using imipenem/cilastatin sodium for refractory pain from tendinopathy and enthesopathy: Multicenter Study (INSTEP study)

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

1)Numerical Rating Scale (NRS) in 6 months after procedure
2)lateral epicondylitis or medial epiconylitis: Quick Disablities of the Arm, Shoulder and Hand (DASH) score in 6 months after the procedure,
Patella tendinitis: Victorian Institute of Sport Assessment (VISA) score in 6 months after the procedure,
Achilles tendinitis or plantar fasciitis: Foot & Ankle Disability Index (FADI) score in 6 months after the procedure
3)Quality of life(QOL) in 6 months after the procedure

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Transcatheter arterial micro embolization: TAME

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

12

years-old

<=

Age-upper limit

85

years-old

>

Gender

Male and Female

Key inclusion criteria

1.Previous conservative therapies applied for at least 3 months and persistent moderate-to-severe hip pain (NRS>=5).
2.Lateral epicondylitis, medial epicondylitis, patella tendinitis, Achilles tendinitis, or plantar fasciitis is clinically diagnosed or suspected.
3.Patients with maintain major organ (bone marrow, heart, liver, lung, kidney) function.
4.Patients with possibility of going to hospital and follow up for 6 months.
5.Provided written informed consent to undergo the procedure.

Key exclusion criteria

1.Surgical candidate
2.Patients with severe infection, rheumatoid arthritis, or mental disorder
3.Patients with uncontrollable diabetic mellitus
4.Pain due to spine pathology
5.Patients with osteonecrosis with magnetic resonance imaging (MRI)
6.Patients without possibility of going to hospital and follow up for 6 months.
7.Patient who was decided not to be appropriate for this trial by physician

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Taku Yasumoto

Organization

Miyakojima IGRT clinic

Division name

Department of Interventional Radiology

Zip code

Address

1-16-22 Miyakojima Hondori, Miyakojima-ku, Osaka, 534-0021, JAPAN

TEL

06-6923-3501

Email

yasumoto@solid.ocn.ne.jp

Name of contact person

1st name
Middle name
Last name	Taku Yasumoto

Organization

Miyakojima IGRT clinic

Division name

Department of Interventional Radiology

Zip code

Address

1-16-22 Miyakojima Hondori, Miyakojima-ku, Osaka, 534-0021, JAPAN

TEL

06-6923-3501

Homepage URL

Email

yasumoto@solid.ocn.ne.jp

Institute

Miyakojima IGRT clinic

Institute

Department

Personal name

Organization

none

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

都島放射線科クリニック（大阪府）
社会福祉法人仁生社 江戸川病院（東京都）

Date of disclosure of the study information

2016

Year

10

Month

13

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

Completed

Date of protocol fixation

2016

Year

10

Month

12

Day

Date of IRB

Anticipated trial start date

2016

Year

10

Month

13

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

10

Month

13

Day

Last modified on

2018

Year

05

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028072