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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009701
Receipt No. 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

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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
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
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011372

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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