UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009701 |
|---|---|
| Receipt number | R000011372 |
| Scientific Title | Interfascial injection of physiological saline, local anethesia and extracellular fluid for myofascial pain syndrome: A prospective, randomized, double-blinded trial. |
| Date of disclosure of the study information | 2013/01/17 |
| Last modified on | 2016/12/28 09:58:40 |
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Basic information
Public title
Interfascial injection of physiological saline, local anethesia and extracellular fluid for myofascial pain syndrome: A prospective, randomized, double-blinded trial.
Acronym
Controlled trial of interfascial injection for myofascial pain syndrome.
Scientific Title
Interfascial injection of physiological saline, local anethesia and extracellular fluid for myofascial pain syndrome: A prospective, randomized, double-blinded trial.
Scientific Title:Acronym
Controlled trial of interfascial injection for myofascial pain syndrome.
Region
| Japan |
Condition
Condition
myofascial pain syndrome
Classification by specialty
| Orthopedics | Anesthesiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will compare the efficacy, safety and convenience of interfascial injection with physiological saline, local anesthetic and extracellular fluid for myofascial pain syndrome. We will elucidate action mechanisms of the injection.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain intensity
Pain relief time
Injection related pain
Key secondary outcomes
Range of motion
Adverse Event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Interfascial injection of
physiological saline
Interventions/Control_2
Interfascial injection of
extracellular fluid
or
Interfascial injection of
local anesthetic
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.
3.exquisite tenderness spot (myofascial trigger point:MTrP) in a taut band.
4.patient's recognition of current pain complain evoked by pressure on a MTrP.
5.painful limitation of the passive range of motion by muscle pain.
Key exclusion criteria
taking anti-thrombosis drugs or anti coagulant drugs.
the history of bleeding disorders
the presence of cancer.
the history of a spine or a shoulder surgery.
the presence of local or systemic infection.
Acute trauma (within a week)
Allergy to anesthetic agents
Extreme fear of needles
Target sample size
80
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
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 | 01 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://ci.nii.ac.jp/naid/120005848554
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
Completed
Date of protocol fixation
| 2012 | Year | 11 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 26 | 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 | 01 | Month | 06 | Day |
Last modified on
| 2016 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011372
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
