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Comparison of shock-wave Therapy and Low level laser on treatment of the Myofascial Trigger Points of Trapezius Muscles: A Randomized single-blind Clinical Trial

Protocol summary

Study aim
The aim of this research is comparing the effect of shockwave therapy and low level laser on treatment of myofascial trigger points of trapezius muscles. This study is a single-blind clinical trial. Seventy two patients will refer to the Fattemieh physiotherapy clinic in Rafsanjan. Three interventions of this study are shockwave, low level laser and conventional therapy of physiotherapy.
Design
In this study 3 treatment group will done through parallel design and assesses during 1st, 10th sessions and one month later.
Settings and conduct
In this study assessor evaluates the patients refer to Fattemieh physiotherapy clinic and divided them into 3 equal groups randomly.
Participants/Inclusion and exclusion criteria
Inclusion: aged 20-60 years, one month following the onset of pain, pain of trigger points are exist only in trapezius muscles. Criteria for selection of samples is based on Travel and Simons physical examination. Exclusion: tumor, use of anticoagulation drug, very insufficiency of kidney, convulsion, radicular pain due to peripheral nerve diseases of the neck and leaving of study.
Intervention groups
First group will use shockwave therapy by shockwave set (made in Novin company of Iran, 360G, 0.08 milijoule, 1.5 pressure, 100 frequency, 1500 shock during 3 minutes on trigger points). Second Group will use Low level laser set (made in Metron of Australia, 8 joule intensity, 100 mw, 810 nm wave length during 3 minutes on trigger points). Third group (conventional physiotherapy) are includes trapezius stretch, during 5 minutes and ultrasound set (made in ITO Japan, 1 MH frequency, 1.5 watt, during 5 minutes) on trigger point.
Main outcome variables
Intensity of local pain, Stiff of band, Radicular pain, Range of neck motion

General information

Reason for update
Acronym
ندارد
IRCT registration information
IRCT registration number: IRCT20100129003220N10
Registration date: 2019-05-28, 1398/03/07
Registration timing: registered_while_recruiting

Last update: 2019-05-28, 1398/03/07
Update count: 0
Registration date
2019-05-28, 1398/03/07
Registrant information
Name
Dadollah Shahimoridi
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 39 1822 0040
Email address
d_shahimoridi@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-06, 1397/12/15
Expected recruitment end date
2020-01-05, 1398/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of shock-wave Therapy and Low level laser on treatment of the Myofascial Trigger Points of Trapezius Muscles: A Randomized single-blind Clinical Trial
Public title
The effect of shock-wave and laser on treatment of the myofascial trigger points of trapezius muscles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged 20-60 years one month following the onset of trigger points of trapezius muscles diagnosis of this points of pain based on travel and simons criteria
Exclusion criteria:
Exclusion are includes tumor Using of anti-coagulation drug serve insufficiency of kidney convulsion radicular pain due to pressure on cervical nerve using of steroids drug prior surgery fracture of cervical and back pregnancy leaving of study.
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
Assessor evaluates the patients based on inclusion criteria, then he divides them to random permuted blocks methods in 3 equal groups and refer to therapist.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study assessor is different from therapist. Assessor is not aware of treatment but therapist and patients are aware from methods of treatment.
Placebo
Not used
Assignment
Parallel
Other design features
none

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The ettics of committe of Rafsanjan University of medical Sciences
Street address
Central organization of Rafsanjan University of Medical Sciences,education assistance, Emam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717893591
Approval date
2019-03-03, 1397/12/12
Ethics committee reference number
IR.RUMS.REC.1397.239

Health conditions studied

1

Description of health condition studied
Musculoskeletal disease
ICD-10 code
M62.9
ICD-10 code description
Disorder of muscle, unspecified

Primary outcomes

1

Description
Intensity of local pain
Timepoint
1st, 10th sessions and one month later
Method of measurement
By Visual Analogue Scale (VAS)

2

Description
Stiff band
Timepoint
1st, 10th sessions and one month later
Method of measurement
Assessor palpates the area of local pain

3

Description
Radicular pain
Timepoint
1st, 10th sessions and one month later
Method of measurement
Assessor asks for the present or absence of radicular pain from patient.

4

Description
Limitation of movement
Timepoint
1st, 10th sessions and one month later
Method of measurement
Assessor evaluates the present or absence of movements limitation of patients.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: First group will receive shock-wave therapy by shock-wave set, made in Iran, 360G model. 0.08 milijoule, 1500 shock during 3 minutes on trigger points.
Category
Rehabilitation

2

Description
Intervention group: Second Group will receive Low level laser by low level laser set, made in Australia, 8 joule intensity, 100 mv, 810 nm for 3 minutes on trigger points.
Category
Rehabilitation

3

Description
Intervention group: Third group (conventional physiotherapy) are includes stretch of trapezius muscles during 5 minutes and ultrasound set (made in ITO company of Japan, 7P model, 1 MH frequency, 1.5 watt intensity during 5 minutes) on myofascial trigger point.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Fattemieh physiotherapy clinic
Full name of responsible person
Dadollah Shahimoridi
Street address
Alley 17, Moalem street
City
Rafsanjan
Province
Kerman
Postal code
7717893591
Phone
+98 34 3426 2926
Fax
+98 34 3428 0097
Email
d_shahimoridi@rums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Hamid Hostad Ebrahimi
Street address
Education Assistance, Central Organization of Rafsanjan University of Medical Sciences, Emam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717893591
Phone
+98 34 3428 0097
Fax
+98 34 3428 0097
Email
d_shahimoridi@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dadollah Shahimoridi
Position
Instructor/Academic member
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Education Assistance, Central Organization of Rafsanjan University of Medical Sciences, Emam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717893591
Phone
+98 34 3433 2341
Fax
+98 34 3428 0097
Email
d_shahimoridi@rums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dadollah Shahimoridi
Position
Instructor/ Academic member
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Education Assistance, Central Organization of Rafsanjan University of Medical Sciences, Emam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717893591
Phone
+98 34 3433 2341
Fax
+98 34 3428 0097
Email
d_shahimoridi@rums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dadollah Shahimoridi
Position
Instructor/Academic member
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Education Assistance, Central Organization of Rafsanjan University of Medical Sciences, Emam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717893591
Phone
+98 34 3433 2341
Fax
+98 34 3428 0097
Email
d_shahimoridi@rums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data of this study will publish in the medical journal and internet.
When the data will become available and for how long
It is possible after one year.
To whom data/document is available
All medical and none medical researchers will access to data.
Under which criteria data/document could be used
It can be used to increase science clinical application.
From where data/document is obtainable
Researchers refers to author, internet, medical journal and libraries.
What processes are involved for a request to access data/document
It is accessible through the internet and medical journals by giving the keyword.
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