UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Interfascial injection of physiological saline, local anethesia and extracellular fluid for myofascial pain syndrome: A prospective, randomized, double-blinded trial.
Title of the study (Brief title)	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	OZAKI, Noriyuki
Organization	Kanazawa University
Division name	Graduate School of Medical Sciences, Department of Functional Anatomy
Address	13-1 Takara-machi, Kanazawa City, 920-8640 Japan
TEL	+81-76-265-2156
Email

Public contact
Name of contact person	KOBAYASHI, Tadashi
Organization	Kanazawa University
Division name	Graduate School of Medical Sciences
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 11 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://ci.nii.ac.jp/naid/120005848554
Results
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