UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of two different procedures in ultrasound-guided dorsal scapular nerve block for interscapular pain
Title of the study (Brief title)	Ultrasound-guided dorsal scapular nerve block for interscapular pain
Region	Japan

Condition
Condition	interscapular pain, shoulder pain, upper back pain, myofascial pain
Classification by specialty	Anesthesiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the effectiveness of a novel ultrasound-guided dorsal scapular nerve block (serratus posterior superior muscle block) for interscapular myofascial pain
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in numerical pain rating scale before and after the block
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Ultrasound-guided serratus posterior superior muscle block
Interventions/Control_2	Ultrasound-guided trigger point injection
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Patient with interscapular myofascial pain, previously treated via blind trigger point injections
Key exclusion criteria	Allergy for local ansthetics Abnormality in blood coaglation ability
Target sample size	60

Research contact person
Name of lead principal investigator	Taro Fujitani
Organization	Ehime Prefectural Central Hospital
Division name	Department of Anesthesiology and Critical Care
Address	83 Kasuga-machi, Matsuyama-city, Ehime, 790-0024, Japan
TEL	+81-89-947-1111
Email	suko1231@yahoo.co.jp

Public contact
Name of contact person	Yasuko Taketa
Organization	Ehime Prefectural Central Hospital
Division name	Department of Anesthesiology and Critical Care
Address	83 Kasuga-machi, Matsuyama-city, Ehime, 790-0024, Japan
TEL	+81-89-947-1111
Homepage URL
Email	suko1231@yahoo.co.jp

Sponsor
Institute	Ehime Prefectural Central Hospital
Institute
Department

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)

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	2018 Year 01 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 11 Month 24 Day
Anticipated trial start date	2018 Year 01 Month 09 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	2017 Year 11 Month 23 Day
Last modified on	2018 Year 05 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034357