UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	PhaseI/II prospective multi-center clinical trial of intra-arterial infusion of imipenem/cilastatin sodium particle for type1 complex regional pain syndrome in forward arm and hand
Title of the study (Brief title)	PhaseI/II study of intra-arterial infusion for CRPS1 in forward arm and hand
Region	Japan

Condition
Condition	Type1 complex regional pain syndrome in forward arm and hand
Classification by specialty	Orthopedics Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the safety and effectiveness of intra-arterial infusion therapy for CRPS type1 occured in forward arm and hand
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	Clinical response rate of pain relief at 4months after first treatment
Key secondary outcomes	Complication profile and its grade Change of BPI score Change of VAS score Grip power Quantity and frequency of other treatments Change of ROM Change of Quick Dash score Change of skin temperature

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Intra-arterial infusion using Imipenem/cilastatin sodium suspension
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	Type1 CRPS in forward arm and hand with allodynia BPI average >5
Key exclusion criteria	passed more than 12months from onset severe arteriosclerosis HbA1C>8.5 the history of allergy to contrast enhance
Target sample size	25

Research contact person
Name of lead principal investigator	Yuji Okuno
Organization	Edogawa Hospital
Division name	Musculoskeletal Intervention Center
Address	2-24-18, Higashikoiwa, Edogawa-ku, Tokyo
TEL	03-3673-1221
Email	okuno@edogawa.or.jp

Public contact
Name of contact person	Yuji Okuno
Organization	Edogawa Hospital
Division name	Musculoskeletal Intervention Center
Address	2-24-18, Higashikoiwa, Edogawa-ku, Tokyo
TEL	03-3673-1221
Homepage URL
Email	okuno@edogawa.or.jp

Sponsor
Institute	Edogawa Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 07 Month 25 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 07 Month 20 Day
Anticipated trial start date	2016 Year 07 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 07 Month 20 Day
Last modified on	2016 Year 07 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025394