UMIN-CTR Clinical Trial

Basic information
Public title	Effect of visual feedback during ultrasound-guided interfascial injection for myofascial pain syndrome
Acronym	Visual feedback during ultrasound-guided injection
Scientific Title	Effect of visual feedback during ultrasound-guided interfascial injection for myofascial pain syndrome
Scientific Title:Acronym	Visual feedback during ultrasound-guided injection
Region	Japan

Condition
Condition	myofascial pain syndrome
Classification by specialty	Psychosomatic Internal Medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We aimed to clarify how the effect of visual feedback during ultrasound-guided interfascial injection for myofascial pain syndrome affected the expectations for the treatment and subsequent course of pain.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The percentage of patients who improved their pain NRS score by 50% or more at 14 days after starting the intervention.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Gender	Male and Female
Key inclusion criteria	The outpatients who received ultrasound-guided interfascial injection for MPS of the upper back
Key exclusion criteria	(1) were younger than 20 years (2) had any comorbidity relating to psychiatric diseases or conditions that made communication difficult, such as cognitive impairment
Target sample size	136

Research contact person
Name of lead principal investigator	1st name Hideaki Middle name Last name Hasuo
Organization	Kansai Medical University
Division name	Department of Psychosomatic Medicine
Zip code	573-1010
Address	2-5-1 Shinmachi, Hirakata, Osaka
TEL	072-804-0101
Email	hasuohid@hirakata.kmu.ac.jp

Public contact
Name of contact person	1st name Hideaki Middle name Last name Hasuo
Organization	Kansai Medical University
Division name	Department of Psychosomatic Medicine
Zip code	573-1010
Address	2-5-1 Shinmachi, Hirakata, Osaka
TEL	072-804-0101
Homepage URL
Email	hasuohid@hirakata.kmu.ac.jp

Sponsor
Institute	Kansai Medical University
Institute
Department

Funding Source
Organization	Kansai Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Kansai Medical University
Address	2-5-1 Shinmachi, Hirakata, Osaka
Tel	072-804-0101
Email	hasuohid@hirakata.kmu.ac.jp

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	関西医科大学附属病院（大阪府）、表参道ペインクリニック（北海道）

Other administrative information
Date of disclosure of the study information	2021 Year 01 Month 28 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	136
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	Completed
Date of protocol fixation	2019 Year 02 Month 22 Day
Date of IRB	2019 Year 03 Month 05 Day
Anticipated trial start date	2019 Year 03 Month 05 Day
Last follow-up date	2020 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	1)a prospective observational clinical trial 2)retrospectively registered

Management information
Registered date	2021 Year 01 Month 28 Day
Last modified on	2021 Year 01 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049208