UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011050 |
|---|---|
| Receipt number | 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 21:34:36 |
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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
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
tkobayashi@stu.kanazawa.ac.jp
Sponsor or person
Institute
Graduate School of Medical Sciences, Department of Functional Anatomy
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012933
