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General information
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44
44
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2020-08-07, 1399/05/17
2020-08-07 00:00:00
empty
2021-01-11, 1399/10/22
2021-01-11 00:00:00
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2021-04-12, 1400/01/23
2021-04-12 00:00:00
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Record the actual sample size, the start and end date of the actual sampling and the end date of the trial
Record the actual sample size, the start and end date of the actual sampling and the end date of the trial
empty
ثبت حجم نمونه تحقق یافته ، تاریخ شروع و پایان نمونه گیری تحقق یافته و تاریخ خاتمه کارآزمایی
ثبت حجم نمونه تحقق یافته ، تاریخ شروع و پایان نمونه گیری تحقق یافته و تاریخ خاتمه کارآزمایی
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: حمیدرضا فاتح
Full name of responsible person - Persian: Hamid Reza Fateh
Street address - English: Jalal ale-ahmad highway
Street address - Persian: بزرگراه جلال ال احمد
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1111111111
Phone: +98 21 8822 5880
Fax:
Email: hr-fateh@tums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: محمدعلی صحرائیان
Full name of responsible person - Persian: Mohammad Ali Sahraian
Street address - English: Imam Khomeini Ave., Hasan Abad Sq., Sina Hospital Tehran – Iran
Street address - Persian: خیابان امام خمینی- میدان حسن آباد - بیمارستان سینا
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1111111111
Phone: +98 21 6670 6142
Fax:
Email: msahrai@tums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: حمیدرضا فاتحمحمدعلی صحرائیان Full name of responsible person - Persian: Hamid Reza FatehMohammad Ali Sahraian Street address - English: Jalal ale-ahmad highwayImam Khomeini Ave., Hasan Abad Sq., Sina Hospital Tehran – Iran Street address - Persian: بزرگراه جلال ال احمدخیابان امام خمینی- میدان حسن آباد - بیمارستان سینا City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1111111111 Phone: +98 21 8822 58806670 6142 Fax: Email: hr-fatehmsahrai@tums.ac.ir Web page address:
Protocol summary
Study aim
Evaluation of the effectiveness of massage cupping on pain, fatigue and quality of life in patient with trapezius myofascial syndrome
Design
This is a two arm parallel group randomized control clinical trial including intervention(A) and control(B) groups. The patients with trapezious myofacial syndrome assigned into one the two groups by using sealed envelops. The patients, the persons which perform the intervention and the person who analyze the data are unaware about patient assignment.
Settings and conduct
40 patients with trapezius myofascial syndrome referred from physical medicine and rehabilitation office based on inclusion and exclusion criteria. After describing the study, method and the objectives, the patients signed an informed consent and divided in two group randomly by using sealed envelops: 1-massage cupping therapy 2- control group. At first demographic and disease history questionnaire and SF-36 QOL questionnaire will be completed and pain will be measured using visual analog scale (VAS) for all patients then, the first group will be treated by massage cupping for 4 weeks(2 sessions a week), every session lasts 15 minutes. Massage cupping will be done using negative pressure of a suction while it is moving on the terapezus muscle with a relative high pressure. Control group will receive only drug therapy the same as intervention group. All data will be collected after the last session of therapy as well as one and three months later. Data will be analyzed with SPSS using ANOVA and repeated measure test.
Participants/Inclusion and exclusion criteria
patient with trapezius myofascial syndrome
Intervention groups
Group A: massage cupping therapy and drug therapy
Group B: drug therapy
Drug therapy: drug therapy for both groups: Tab acetaminophen 500mg daily
Main outcome variables
Pain
General information
Reason for update
Record the actual sample size, the start and end date of the actual sampling and the end date of the trial
Acronym
IRCT registration information
IRCT registration number:IRCT20180804040685N2
Registration date:2020-08-03, 1399/05/13
Registration timing:prospective
Last update:2021-04-15, 1400/01/26
Update count:2
Registration date
2020-08-03, 1399/05/13
Registrant information
Name
Hamid Reza Fateh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2110
Email address
hr-fateh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
2020-08-07, 1399/05/17
Actual recruitment end date
2021-01-11, 1399/10/22
Trial completion date
2021-04-12, 1400/01/23
Scientific title
Evaluation of the effectiveness of massage cupping on pain and quality of life in patient with trapezius myofascial syndrome
Public title
Evaluation of the effectiveness of massage cupping in patient with trapezius myofascial syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patient with trapezius myofascial syndrome according to physiatrist diagnosis
18-65 y/o
VAS>2
Exclusion criteria:
Patients with uncontrolled systemic disease
Patients with similar symptoms such as radiculopathy, etc
Patients with coagulopathy or treated with anticoagulants
CNS disorders
Mental disorders and bacterial infection
Pregnant
Local disease
Participate in other studies and interventions
Disinclination to continue participating in the present study
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
44
Randomization (investigator's opinion)
Randomized
Randomization description
The patients primary evaluation, will be assigned into one of the 2 groups A or B randomly by using sealed envelops, so that each patient picks up a sealed envelop in which the group A or B is defined and enters to one of the two groups.
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
Ethic committee, Tehran University of Medical Sciences
Street address
Jalal aleahmad Highway
City
Tehran
Province
Tehran
Postal code
1417863181
Approval date
2019-06-03, 1398/03/13
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1398.177
Health conditions studied
1
Description of health condition studied
trapezius myofascial syndrome
ICD-10 code
ICD-10 code description
سندرم میوفاسیال
Primary outcomes
1
Description
pain
Timepoint
before and after intervention and one and three months after end of intervention
Method of measurement
Visual Analog Scale
2
Description
quality of life
Timepoint
before and after intervention and one and three months after end of intervention
Method of measurement
SF-36 QOL questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group(massage cupping): cupping will be perform by moving a cup over the trapezious muscle by imposing negative pressure trough suctioning.
Category
Rehabilitation
2
Description
Control group: control group only receive routine drugs.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان شریعتی
Full name of responsible person
Saeed Reza Mehrpoor
Street address
Jalal Ale-ahmad highway
City
Tehran
Province
Tehran
Postal code
1111111111
Phone
+98 21 8822 5880
Email
hr-fateh@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
محمدعلی صحرائیان
Street address
Imam Khomeini Ave., Hasan Abad Sq., Sina Hospital Tehran – Iran
City
Tehran
Province
Tehran
Postal code
1111111111
Phone
+98 21 6670 6142
Email
msahrai@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Hamid Reza Fateh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Jalal ale-ahmad highway
City
Tehran
Province
Tehran
Postal code
1111111111
Phone
+98 21 8822 5880
Email
hr-fateh@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamidreza fateh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Jalal ale-ahmad highway
City
Tehran
Province
Tehran
Postal code
1111111111
Phone
+98 21 8822 5880
Email
hr-fateh@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamidrezaq fateh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Jalal ale-ahmad highway
City
Tehran
Province
Tehran
Postal code
1111111111
Phone
+98 21 8822 5880
Email
hr-fateh@tums.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
preservation of patients private limit
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
all data will be shared after making them non-identified-able the patients
When the data will become available and for how long
6 months after ending the study
To whom data/document is available
researchers in universities and scientific associations
Under which criteria data/document could be used
for confirming to be publication
From where data/document is obtainable
corresponding auther
What processes are involved for a request to access data/document