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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000011050
Receipt No. R000012933
Scientific Title The change of muscle nodule before and after trigger point injection for myofascial pain syndrome. A new ultrasonography visualizes muscle nodule and measures the elasticity; observational trial
Date of disclosure of the study information 2013/07/01
Last modified on 2013/06/26

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Basic information
Public title The change of muscle nodule before and after trigger point injection for myofascial pain syndrome. A new ultrasonography visualizes muscle nodule and measures the elasticity; observational trial
Acronym The image change detection of muscle nodule before and after trigger point injection for myofascial pain syndrome by urtrasonography
Scientific Title The change of muscle nodule before and after trigger point injection for myofascial pain syndrome. A new ultrasonography visualizes muscle nodule and measures the elasticity; observational trial
Scientific Title:Acronym The image change detection of muscle nodule before and after trigger point injection for myofascial pain syndrome by urtrasonography
Region
Japan

Condition
Condition myofascial pain syndrome
Classification by specialty
Orthopedics Anesthesiology Rehabilitation medicine
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 A new ultrasonography technique can visualize the change of shape and elasticity of muscle nodule before and after trigger point injection. We estimate the relation between palpation and the image of muscle nodule. We will check reliability of Ultrasonography.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes elasticity of muscle nodule
Key secondary outcomes shape of muscle nodule by palpation
shape of muscle nodule by ultrasonography
pressure pain threshold of muscle nodule
reliability

Base
Study type

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 trigger point injectioni by local anesthetic
Interventions/Control_2 no injeciton
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 Myofascial pain syndrome patients who meet the following criteria;
1 regional muscle pain
2 palpation of taut band in painful muscles exquisite tenderness spot (myofascial trigger point; MTrP in a taut band
3 patient's recognition of current pain
4 complaint evoked by pressure on a MTrP
Key exclusion criteria taking anti-thrombosis drugs or anti coagulant drugs.
history of bleeding disorders
presence of cancer.
history of shoulder surgery.
presence of local or systemic infection.
acute trauma (within a week)
allergy to anesthetic agents
extreme fear of needles
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name OZAKI, Noriyuki
Organization Kanazawa University
Division name Graduate School of Medical Sciences, Department of Functional Anatomy
Zip code
Address 13-1 Takara-machi, Kanazawa City, 920-8640 Japan
TEL +81-76-265-2156
Email

Public contact
Name of contact person
1st name
Middle name
Last name KOBAYASHI, Tadashi
Organization Kanazawa University
Division name Graduate School of Medical Sciences
Zip code
Address
TEL
Homepage URL
Email tkobayashi@stu.kanazawa.ac.jp

Sponsor
Institute Graduate School of Medical Sciences, Department of Functional Anatomy
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 25001025
Org. issuing International ID_1 Chubu unversity
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 木村ペインクリニック(群馬県)
KIMURA PAIN CLINIC(Gunma prefecture)

Other administrative information
Date of disclosure of the study information
2013 Year 07 Month 01 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 Enrolling by invitation
Date of protocol fixation
2013 Year 05 Month 23 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 06 Month 26 Day
Last modified on
2013 Year 06 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012933

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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