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Protocol summary
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.
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. For the second group (control group), a routine exercise therapy was performed. The exercises consisted of three strengthening exercises and five stretching exercises for the upper, middle and lower trapezius muscles. Each movement was performed 10 repetitions and 3 times a day. All data will be collected after the last session of therapy as well as three months later. Data will be analyzed with SPSS using ANOVA and repeated measure test.
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 pressureFor the second group (control group), a routine exercise therapy was performed. The exercises consisted of a suction while it is moving onthree strengthening exercises and five stretching exercises for the terapezus muscle withupper, middle and lower trapezius muscles. Each movement was performed 10 repetitions and 3 times a relative high pressure. Control group will receive only drug therapy the same as intervention groupday. 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.
40 نفر بیمار مبتلا به سندرم درد میوفاسیال عضله تراپزیوس از بین بيماران مراجعه كننده به درمانگاه طب فيزيكى بيمارستان شريعتى بر اساس معیارهای ورود و خروج به بخش توانبخشی معرفی می شوند. این بیماران پس از شرح مطالعه، اهداف آن و روشهای اندازه گیری و درمان برای هر یک به صورت جداگانه و تکمیل فرم رضایتنامه آگاهانه وارد مطالعه شده و به صورت تصادفي با استفاده از پاکتهای سربسته به دو گروه تقسیم می شوند: 1-گروه درمان به روش massage cupping، 2- گروه شاهد. ابتدا پرسشنامه های مربوط به اطلاعات فردی، شرح حال بیماری، اندازه گیری درد و علائم(VAS)، کیفیت زندگی(SF-36) برای آنها تکمیل شده و سپس هر یک از گروهها به مدت 4 هفته تحت درمان قرار می گیرند. هر دو گروه از نظر درمان دارویی یکسان بوده ، گروه درمان با cupping توسط فیزیوتراپیست به مدت 4 هفته (2 جلسه 15 دقیقه ای در هفته، به روش massage cupping، با اعمال فشارمنفی از طریق ساکشن و به صورتی که کاپ در مسیر عضله تراپزیوس با فشار نسبتا زیاد حرکت داده می شود) تحت درمان قرار می گیرند. گروه شاهد تنها تحت درمان با دارو قرار می گیرند. بلافاصله پس از آخرین جلسه درمان و به فاصله یک و سه ماه پس از آن همه اندازه گیریهای اولیه برای هر دو گروه بیماران انجام می شود و اطلاعات با نرم افزار SPSS با آزمونهایANOVA و repeated measure تجزیه و تحلیل می شوند.
40 نفر بیمار مبتلا به سندرم درد میوفاسیال عضله تراپزیوس از بین بيماران مراجعه كننده به درمانگاه طب فيزيكى بيمارستان شريعتى بر اساس معیارهای ورود و خروج به بخش توانبخشی معرفی می شوند. این بیماران پس از شرح مطالعه، اهداف آن و روشهای اندازه گیری و درمان برای هر یک به صورت جداگانه و تکمیل فرم رضایتنامه آگاهانه وارد مطالعه شده و به صورت تصادفي با استفاده از پاکتهای سربسته به دو گروه تقسیم می شوند: 1-گروه درمان به روش massage cupping، 2- گروه شاهد. ابتدا پرسشنامه های مربوط به اطلاعات فردی، شرح حال بیماری، اندازه گیری درد و علائم(VAS)، کیفیت زندگی(SF-36) برای آنها تکمیل شده و سپس هر یک از گروهها به مدت 4 هفته تحت درمان قرار می گیرند. هر دو گروه از نظر درمان دارویی یکسان بوده ، گروه درمان با cupping توسط فیزیوتراپیست به مدت 4 هفته (2 جلسه 15 دقیقه ای در هفته، به روش massage cupping، با اعمال فشارمنفی از طریق ساکشن و به صورتی که کاپ در مسیر عضله تراپزیوس با فشار نسبتا زیاد حرکت داده می شود) تحت درمان قرار می گیرند. گروه شاهد تنها تحت تمرین درمانی روتین قرار می گیرند. بلافاصله پس از آخرین جلسه درمان و سه ماه پس از آن همه اندازه گیریهای اولیه برای هر دو گروه بیماران انجام می شود و اطلاعات با نرم افزار SPSS با آزمونهایANOVA و repeated measure تجزیه و تحلیل می شوند.
40 نفر بیمار مبتلا به سندرم درد میوفاسیال عضله تراپزیوس از بین بيماران مراجعه كننده به درمانگاه طب فيزيكى بيمارستان شريعتى بر اساس معیارهای ورود و خروج به بخش توانبخشی معرفی می شوند. این بیماران پس از شرح مطالعه، اهداف آن و روشهای اندازه گیری و درمان برای هر یک به صورت جداگانه و تکمیل فرم رضایتنامه آگاهانه وارد مطالعه شده و به صورت تصادفي با استفاده از پاکتهای سربسته به دو گروه تقسیم می شوند: 1-گروه درمان به روش massage cupping، 2- گروه شاهد. ابتدا پرسشنامه های مربوط به اطلاعات فردی، شرح حال بیماری، اندازه گیری درد و علائم(VAS)، کیفیت زندگی(SF-36) برای آنها تکمیل شده و سپس هر یک از گروهها به مدت 4 هفته تحت درمان قرار می گیرند. هر دو گروه از نظر درمان دارویی یکسان بوده ، گروه درمان با cupping توسط فیزیوتراپیست به مدت 4 هفته (2 جلسه 15 دقیقه ای در هفته، به روش massage cupping، با اعمال فشارمنفی از طریق ساکشن و به صورتی که کاپ در مسیر عضله تراپزیوس با فشار نسبتا زیاد حرکت داده می شود) تحت درمان قرار می گیرند. گروه شاهد تنها تحت درمان با داروتمرین درمانی روتین قرار می گیرند. بلافاصله پس از آخرین جلسه درمان و به فاصله یک و سه ماه پس از آن همه اندازه گیریهای اولیه برای هر دو گروه بیماران انجام می شود و اطلاعات با نرم افزار SPSS با آزمونهایANOVA و repeated measure تجزیه و تحلیل می شوند.
Group A: massage cupping therapy and drug therapy
Group B: drug therapy
Drug therapy: drug therapy for both groups: Tab acetaminophen 500mg daily
Group A: massage cupping therapy and drug therapy
Group B: exercise therapy and drug therapy
Drug therapy: drug therapy for both groups: Tab acetaminophen 500mg daily
Group A: massage cupping therapy and drug therapy Group B: exercise therapy and drug therapy Drug therapy: drug therapy for both groups: Tab acetaminophen 500mg daily
گروهA: ماساژ بادکش و دارو درمانی
گروهB: دارودرمانی
دارودرمانی برای دوگروه: قرص استامینوفن500، یک عدد در روز
گروهA: ماساژ بادکش و دارو درمانی
گروهB: تمرین درمانی و دارو
دارودرمانی برای دوگروه: قرص استامینوفن500، یک عدد در روز
گروهA: ماساژ بادکش و دارو درمانی گروهB: دارودرمانیتمرین درمانی و دارو دارودرمانی برای دوگروه: قرص استامینوفن500، یک عدد در روز
General information
Record the actual sample size, the start and end date of the actual sampling and the end date of the trial
Correction of the control group
Record the actual sample size, the start and end dateCorrection of the actual sampling and the end date of the trialcontrol group
ثبت حجم نمونه تحقق یافته ، تاریخ شروع و پایان نمونه گیری تحقق یافته و تاریخ خاتمه کارآزمایی
اصلاح گروه کنترل
ثبت حجم نمونه تحقق یافته ، تاریخ شروع و پایان نمونه گیری تحقق یافته و تاریخ خاتمه کارآزماییاصلاح گروه کنترل
Primary outcomes
#1
before and after intervention and one and three months after end of intervention
before and after intervention and three months after end of intervention
before and after intervention and one and three months after end of intervention
قبل و بعد از مداخله، یک ماه و 3ماه پس از اتمام مداخله
قبل و بعد از مداخله و 3ماه پس از اتمام مداخله
قبل و بعد از مداخله، یک ماه و 3ماه پس از اتمام مداخله
Intervention groups
#1
Treatment - Drugs
Rehabilitation
treatment-drugsrehabilitaion
Control group: control group only receive routine drugs.
Control group: control group receive routine exercise therapy and drug.
Control group: control group only receive routine drugsexercise therapy and drug.
گروه کنترل: تنها تحت درمان با دارو قرار می گیرند.
گروه کنترل: تحت تمرین درمانی با دارو قرار می گیرند.
گروه کنترل: تنها تحت درمانتمرین درمانی با دارو قرار می گیرند.
Recruitment centers
#1
Name of recruitment center - English: بیمارستان شریعتی
Name of recruitment center - Persian: Shariati Hospital
Full name of responsible person - English: Saeed Reza Mehrpoor
Full name of responsible person - Persian: سعیدرضا مهرپور
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 recruitment center - English: Shariati Hospital
Name of recruitment center - Persian: بیمارستان شریعتی
Full name of responsible person - English: Saeed Reza Mehrpoor
Full name of responsible person - Persian: سعیدرضا مهرپور
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 recruitment center - English: بیمارستان شریعتیShariati Hospital Name of recruitment center - Persian: Shariati Hospitalبیمارستان شریعتی Full name of responsible person - English: Saeed Reza Mehrpoor Full name of responsible person - Persian: سعیدرضا مهرپور 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:
Sponsors / Funding sources
#1
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: Mohammad Ali Sahraian
Full name of responsible person - Persian: محمدعلی صحرائیان
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: محمدعلی صحرائیانMohammad Ali Sahraian Full name of responsible person - Persian: Mohammad Ali Sahraianمحمدعلی صحرائیان 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:
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. For the second group (control group), a routine exercise therapy was performed. The exercises consisted of three strengthening exercises and five stretching exercises for the upper, middle and lower trapezius muscles. Each movement was performed 10 repetitions and 3 times a day. All data will be collected after the last session of therapy as well as 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: exercise therapy and drug therapy
Drug therapy: drug therapy for both groups: Tab acetaminophen 500mg daily
Main outcome variables
Pain
General information
Reason for update
Correction of the control group
Acronym
IRCT registration information
IRCT registration number:IRCT20180804040685N2
Registration date:2020-08-03, 1399/05/13
Registration timing:prospective
Last update:2021-05-03, 1400/02/13
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 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 receive routine exercise therapy and drug.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
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
Mohammad Ali Sahraian
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