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Comparison the effects of 5-week myofascial self-release and massage therapy in women with myofascial pain syndrome of Trapezius muscle: clinical trials

Protocol summary

Study aim
The general purpose of this research is to compare the effect of myofascial self-release exercises and massage for 5 weeks on complications caused by trapezius muscle myofascial pain syndrome.
Design
The clinical trial has a control group and two experimental groups, which are one-sided blind parallel groups, randomized on 45 people with trapezius muscle myofascial pain syndrome disorder, which randomization will be done by lottery.
Settings and conduct
The research process includes pre-test stages, intervention for 5 weeks, post-test. The procedure is performed in the girls' dormitory of Shahid Beheshti University. During the intervention stages, the massage group received myofascial release massage in the trapezius muscle area, while the training group received myofascial self-release exercises by foam roll and tennis ball.
Participants/Inclusion and exclusion criteria
Women with myofascial pain syndrome and active trigger points in their trapezius muscle, who have no surgery or disorder in the cervical and thoracic spine ,sensitivity to massage oils, skin disease and open wound in the intervention area.
Intervention groups
first experimental group interventions include massage in the trapezius muscle for a specific period of time. In the second experimental group, the intervention of myofascial self-release exercises using foam roll and tennis ball will be used in areas with trigger points in the trapezius muscle. Soft warm-up exercises will be applied in the control group during the intervention period.
Main outcome variables
The disabilities of the arm, shoulder and hand (DASH) questionnaire The visual analog scale (VAS) brief pain inventory Ober pain questionnaire flexion, extension, left and right rotation, left and right flexion range of motion flexion, extension, abduction, internal and external rotation of left and right arm

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230914059432N1
Registration date: 2024-03-29, 1403/01/10
Registration timing: retrospective

Last update: 2024-03-29, 1403/01/10
Update count: 0
Registration date
2024-03-29, 1403/01/10
Registrant information
Name
Sara Matinfard
Name of organization / entity
Faculty of Physical Education and Sport Sciences, University shahid beheshti
Country
Iran (Islamic Republic of)
Phone
+98 51 4222 6487
Email address
s.matinfard@mail.sbu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-29, 1402/07/07
Expected recruitment end date
2023-11-28, 1402/09/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effects of 5-week myofascial self-release and massage therapy in women with myofascial pain syndrome of Trapezius muscle: clinical trials
Public title
Comparison the effects of 5-week myofascial self-release and massage therapy in women with myofascial pain syndrome of Trapezius muscle: clinical trials
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having active trigger points in the trapezius muscle Not using an exercise program or any other modalities which can effects persons pain experience caused by trigger points during the research period. Female gender Absence of pregnancy induvial must not any history of surgery or disorder in the cervical and thoracic spine Not having skin diseases and open wounds Not having an allergy to massage oils The minimum age is 20 and the maximum is 30
Exclusion criteria:
Use of alcohol and other drugs Not participating in massage sessions or training for two consecutive sessions Dissatisfaction with the continuation of the activity and cooperation in the current research Absence of individual during the pre-test and post-test session
Age
From 20 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
The names of the people will be written on similar sheets and the names are drawn randomly in the form of a lottery. The first 15 people will be divided into experimental group one, the second 15 people will be divided into experimental group two, and the third 15 people will be divided into the control group..
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University
Street address
No. 2, Sepas AVE., Beh Afarin St., Karimkhan BLVD., Tehran Town
City
Tehran
Province
Tehran
Postal code
15938566314
Approval date
2023-05-29, 1402/03/08
Ethics committee reference number
IR.SBU.REC.1402.067

Health conditions studied

1

Description of health condition studied
myofascial pain syndrome
ICD-10 code
G89.29
ICD-10 code description
Other chronic pain

Primary outcomes

1

Description
trigger points pain
Timepoint
Pain measurement will be done at the beginning of the study during the pre-test stage and at the end of the study in the post-test stage
Method of measurement
Using The visual analog scale (VAS) and The Brief Pain Inventory (BPI)

2

Description
Neck range of motion in flexion, extension, rotation, and lateral flexion movements
Timepoint
Range of motion measurement will be done at the beginning of the study during the pre-test stage and at the end of the study in the post-test stage
Method of measurement
Using Goniometer

3

Description
Shoulder range of motion in flexion, extension, abduction, internal and external rotation
Timepoint
Range of motion measurement will be done at the beginning of the study during the pre-test stage and at the end of the study in the post-test stage
Method of measurement
Using Goniometer

4

Description
Hand and shoulder performance quality
Timepoint
Hand and shoulder performance quality will be measured at the beginning of the study during the pre-test stage and at the end of the study in the post-test stage
Method of measurement
The disabilities of the arm, shoulder and hand (DASH) questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group: myofascial release massage for 2 days a week with variable times (gradual increase each week) for 5 weeks in which Swedish massage techniques will be used in the trapezius muscle area.
Category
Treatment - Other

2

Description
second intervention group: Myofascial self-release for 2 sessions per week for 5 weeks using foam roll and tennis ball in variable durations (gradual increase each week).
Category
Treatment - Other

3

Description
Control group: Soft exercise activity similar to warm-up is done for a short period of time for this group of people.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti university
Full name of responsible person
Sara Matin Fard
Street address
NO. 2, Sepas Ave., Beh Afrin St., karimkhan Blvd., Theran Town
City
Tehran
Province
Tehran
Postal code
1593856314
Phone
+98 51 4222 6487
Email
s.matinfard@sbu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshar Jafari
Street address
No. 2, Sepas Ave., Beh Afrin St., Karim Khan Blvd., Tehran Town
City
Tehran
Province
Tehran
Postal code
1593856314
Phone
+98 51 4222 6487
Email
s.matinfard@sbu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahid Beheshti University Faculty of Sports Sciences and Health
Proportion provided by this source
1
Public or private sector
Private
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
Shahid Beheshti University Faculty of Sports Sciences and Health
Full name of responsible person
Sara Matinfard
Position
university student
Latest degree
Bachelor
Other areas of specialty/work
Sport injuries and corrective exercise
Street address
No. 2, Sepas AVE., Beh Afarin St., Karimkhan BLVD., Tehran Town
City
Tehran
Province
Tehran
Postal code
1593856314
Phone
+98 51 4222 6487
Email
s.matinfard@sbu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University Faculty of Sports Sciences and Health
Full name of responsible person
Sara Matin Fard
Position
university student
Latest degree
Bachelor
Other areas of specialty/work
Sport injuries and corrective exercise
Street address
NO. 2, Sepas Ave., Beh Afrin St., karimkhan Blvd., Theran Town
City
Tehran
Province
Tehran
Postal code
1593856314
Phone
+98 51 4222 6487
Email
s.matinfard@sbu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University Faculty of Sports Sciences and Health
Full name of responsible person
Sara Matin Fard
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Sport injuries and corrective exercise
Street address
No. 2, Sepas Ave., Beh Afrin St., Karim Khan Blvd., Tehran Town
City
Tehran
Province
Tehran
Postal code
1593856314
Phone
+98 51 4222 6487
Email
s.matinfard@sbu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The final results of the current research will be published in the form of statistical analysis in the form of articles or dissertations and not in the form of raw data of individual participants.
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The information and statistical analyzes carried out in the format of articles and dissertations will be shared from the results of this research. Thesis title: Comparison of the effect of 5 weeks of myofascial self-release and massage on women with myofascial pain syndrome of the trapezius muscle: a clinical trial Possible title of the article: Comparison of the effect of 5 weeks of myofascial self-release and massage on women with myofascial pain syndrome of the trapezius muscle: a clinical trial
When the data will become available and for how long
The access period starts after the registration of the final thesis in the period of January 1402 to January 1403.
To whom data/document is available
Researchers interested in the field of myofascial pain syndrome, self-release and massage
Under which criteria data/document could be used
It is possible for other researchers to cite the results of this research (by mentioning its source).
From where data/document is obtainable
Researchers can contact the author through the following email address in order to obtain information about the article: s.matinfard@sbu.ac.ir
What processes are involved for a request to access data/document
After introducing his field of study and why he wants to study the information of the current study in the text of the email, the applicant can receive the desired data up to a maximum of 2 weeks after receiving the mentioned email and its review by the author.
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