UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014591
Receipt No. R000016719
Scientific Title Phase 1/2 trial of TAME(:Transcatheter arterial micro embolization) for chronic musculoskeletal pain refractory to non-surgical management
Date of disclosure of the study information 2014/07/20
Last modified on 2016/05/06

* 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 Phase 1/2 trial of TAME(:Transcatheter arterial micro embolization) for chronic musculoskeletal pain refractory to non-surgical management
Acronym TAME Phase 1/2 study
Scientific Title Phase 1/2 trial of TAME(:Transcatheter arterial micro embolization) for chronic musculoskeletal pain refractory to non-surgical management
Scientific Title:Acronym TAME Phase 1/2 study
Region
Japan

Condition
Condition Musculoskeletal chronic pain refractory to non-surgical management
Classification by specialty
Orthopedics Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the feasibility and effect of transcatheter arterial micro embolization: TAME for musculoskeletal chronic pain refractory to non-surgical management
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Feasibility
Key secondary outcomes Effectiveness
Frequency of adverse events

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
Maneuver
Interventions/Control_1 Transcatheter arterial micro-embolization
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1. Previous conservative therapies applied for at least 3 months and persistent moderate-to-severe pain (VAS > 50mm).

2.Patients with following diagnosis: adhesive capsulitis, musculoskeletal shoulder pain, tendinopathy and enthesopathy, sinovitis and bursitis, mild osteoarthritis (KL<3), infrapatellar fat pad inflammation, and residual or reccurent pain after knee replacement surgery.

3. Patients who maintain major organ (bone marrow, heart, liver, lung, kidney) function.

4. Provided written informed consent to undergo the procedure.
Key exclusion criteria 1.Reheumatoid arthritis
2.Neoplasm
3.Severe arteriosclerosis
4.Pregnant female
5.Dementia
6.Complaining joint instability
7.Iodine Allergy
8.Patients with severe cardiac disease, cerebrovascular disease, neurological disease, uncontrollable diabetic mellitus and hypertension, severe infection, intestinal bleeding, interstitial pneumonia, ascites fluid, pleural effusion.
9, Pain due to cervical or lumbar spine pathology
10,Patients who was decided not to be appropriate for this trial by physician
Target sample size 33

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Yuji Okuno
Organization Edogawa Hospital
Division name Orthopedic Surgery
Zip code
Address 2-24-18 Higashikoiwa, Edogawa-ku, Tokyo, Japan
TEL 03-3673-1221
Email how_lowlow@yahoo.co.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Yuji Okuno
Organization secretariat of Edogawa Musculoskeletal Intervention Study Group
Division name Orthopedic Surgery
Zip code
Address 2-24-18 Higashikoiwa, Edogawa-ku, Tokyo, Japan
TEL 03-3673-1221
Homepage URL
Email how_lowlow@yahoo.co.jp

Sponsor
Institute Edogawa Musculoskeletal Intervention Study Group
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Institute for Integrated Sports Medicine, School of Medicine, Keio University, Tokyo, Japan
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 江戸川病院

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 20 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 No longer recruiting
Date of protocol fixation
2014 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 20 Day
Last follow-up date
2016 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2016 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2014 Year 07 Month 18 Day
Last modified on
2016 Year 05 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016719

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.