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A comparison between effectiveness of gluteal trigger injection with epidural steroid injection in lumbosacral canal stenosis patients

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History
# Registration date Revision Id
2 2021-05-16, 1400/02/26 183295
1 2020-11-26, 1399/09/06 160432
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  • Protocol summary

    the patient selected from emamreza clinic and rajaee hospital who has lumbosacral canal stenosis. then patients divided into two groups and after obtaining written consent the study begins. in control group steroid epidural injection is done and in intervention group steroid is gluteal trigger point injection then we measure its effect on reducing pain and improving patients function
    The patients who had lumbosacral canal stenosis were selected from Emam Reza clinic and Rajaee hospital, then patients were divided into two groups and after obtaining written consent the study was begun. In the control group, steroid was injected into epidural, and in the intervention group, steroid was injected in the gluteal trigger points. Then its effects on reducing patients' pain and improving function were measured.
    exclusion criterria: Infection involving lumbar spinal (brucella) Diabetes mellitus Rhumatological disorder(lupuse, gout) BMI more than 42 Pregnancy Malignancy Liver disease History of allergies Malnutrition Peripheral neuropathy Bleeding disorder Galactosemia Radiculopathy inclusion criteria: age: 40-75 years old being diagnosis with lumbar canal stenosis accordining to MRI or EDX Complaining low back pain , psudoclaudication ,parestesia that no responsed to conservative treatment sex:male or female
    Exclusion criterria: Infection involving lumbar spinal (brucella), Diabetes mellitus, Rhumatological disorder(lupuse, gout), BMI more than 42 , Pregnancy, Malignancy, Liver disease, History of allergies, Malnutrition, Peripheral neuropathy, Bleeding disorder, Galactosemia, Radiculopathy. Inclusion criteria: Age: 40-75 years old, Being diagnosis with lumbar canal stenosis accordining to MRI or EDX, Complaining low back pain , psudoclaudication ,parestesia that no responsed to conservative treatment , Sex:male or female
    group that receive gluteal trigger point injection of steroid
    Group1: received an injection of steroid into gluteal trigger points. Group 2: received steroid epidural injection under fluoroscopic guide.
    گروهی که استروئید را به صورت داخل عضلانی در نقاط دردناک موضعی گلوتئال دریافت کردند
    1_گروهی که استروئید را به صورت داخل عضلانی در نقاط دردناک موضعی گلوتئال دریافت کردند. 2-گروهی که استرویید را به صورت تزریق اپیدورال زیر گاید فلوروسکوپی دریافت کردند.

  • General information

    Triple blinded
    Double blinded
    1
    44
    50
    empty
    44
    2020-05-20, 1399/02/31
    2020-08-22, 1399/06/01
    2020-12-20, 1399/09/30
    2022-03-10, 1400/12/19
    empty
    2020-11-27, 1399/09/07
    empty
    2021-03-18, 1399/12/28
    empty
    2021-05-14, 1400/02/24
    empty
    1-Date transfer: Due to the delay in the acceptance and approval process and we expected a shorter time, we started the sick time earlier. 2. Being blind on both sides due to a typographical error
    empty
    1-جابجایی تاریخ : به علت اینکه فرایند قبول و تایید با تاخیر بود و ما انتظار زمان کوتاهتر داشتیم زمان بیمارگیری را زودتر شروع کردیم . 2-دوسویه کور بودن به علت اشتباه تایبی ممنون میشم ویرایش رو برای من مقدور کنین با تشکر
    Gluteal trigger point injection in lumbosacral canal stenosis pateints
    Gluteal trigger point injection in lumbosacral canal stenosis patients
    Complete randomize block design with random allocation software is used for randomization and the list of patient is prepared by a computer with the same blocklength and the secretary divides the patients based on the list of patients and the statistical consultant on how to group are unaware.
    Complete randomized block design with random allocation software was used for randomization and the list of patients was prepared by a computer with the same block length and the secretary divided the patients based on the list of patients.
    participanr: in. this study does not have the ability to blind the participant because the participant is aware of receiving each intervention clinical car giver : we teach the caregiver how to complete the questionnaire. this person is not aware of receiving patient intervention . researcher: this study does not have the ability to blind the researcher because performs both intervention himself and is aware of receiving each intervention in the group. The outcome assessor of the complete questionnaires is given to person who is not aware of the intervention performed and he/she is asked to determine the level of performance in each person according to the questionnaires. Data analyzer: questionnaire are finally given to a person to review the information . this person dosenot know any of the eteps of the work , how to classify and the intervention performed.
    clinical caregiver: we taught the caregiver how to complete the questionnaire. this person was not aware of the allocation to groups. The outcome assessor who completed the questionnaires was not aware of the group allocation. Data analyzer: Questionnaires were finally given to a person to review the information. This person does not know any of the steps of the work, how groups were classified and the intervention performed.
    شرکت کننده :در این مطالعه توانایی کورسازی بیمار را نداریم ، چون بیماران هر دو مداخله از نوع مداخله خود اطلاع دارند. مراقب بالینی : به فردی که مراقبت و پیگیری بیماران را بر عهده دارد نحوه تکمیل پرسشنامه را اموزش میدهیم این فرد از نوع مداخله بیمار هیچ اطلاعی ندارد. محقق: در این مطالعه توانایی کورسازی محقق را نداریم ، چون محقق هر دو مطالعه را خودش انجام میدهد و از دریافت نوع مداخله در هر گروه اطلاع دارد. ارزیابی کننده پیامد: پرسشنامه های تکمیل شده به فردی که از مداخلات انجام شده اطلاعی ندارد سپرده میشود و از او خواسته میشود که میزان کاهش درد و افزایش عملکرد در هر فرد را با توجه به پرسشنامه تعیین کند. آنالیز کننده داده ها : پرسشنامه ها در نهایت پس از تکمیل و جمع اوری کلیه اطلاعات به فردی جهت بررسی اطلاعات داده میشود که این فرد از هیچ یک از مراحل انجام کار و نحوه تقسیم بندی مداخله انجام شده اطلاعی ندارد
    مراقب بالینی : به فردی که مراقبت و پیگیری بیماران را بر عهده دارد نحوه تکمیل پرسشنامه را اموزش میدهیم این فرد از نوع مداخله بیمار هیچ اطلاعی ندارد. محقق: در این مطالعه توانایی کورسازی محقق را نداریم ، چون محقق هر دو مطالعه را خودش انجام میدهد و از دریافت نوع مداخله در هر گروه اطلاع دارد. ارزیابی کننده پیامد: پرسشنامه های تکمیل شده به فردی که از مداخلات انجام شده اطلاعی ندارد سپرده میشود و از او خواسته میشود که میزان کاهش درد و افزایش عملکرد در هر فرد را با توجه به پرسشنامه تعیین کند. آنالیز کننده داده ها : پرسشنامه ها در نهایت پس از تکمیل و جمع اوری کلیه اطلاعات به فردی جهت بررسی اطلاعات داده میشود که این فرد از هیچ یک از مراحل انجام کار و نحوه تقسیم بندی مداخله انجام شده اطلاعی ندارد

  • Primary outcomes

    #1
    two weeks, foure weeks , eight weeks
    two weeks, four weeks, eight weeks

  • Secondary outcomes

    #1
    function of patient
    empty
    عملکرد بیمار
    empty
    two weeks, four weeks , eight weeks
    empty
    دو هفته و چهار هفته و هشت هفته
    empty
    Ronald-Morris Disability questionnaire
    empty
    مقیاس اندازه گیری عملکرد بیمار
    empty
    #2
    function of patient
    empty
    عملکرد بیمار
    empty
    two weeks, four weeks , eight weeks
    empty
    دو هفته و چهار هفته و هشت هفته
    empty
    Oswestry Disability index
    empty
    مقیاس اندازه گیری عملکرد بیمار
    empty

  • Intervention groups

    #1
    Intervention group: the group that receive 80 mg methylprednisolon and 4 cc marcaine epidural injection with fluoroscopic guidance and two weeks , four weeks, eight weeks after first dose VAS, Oswestry, Quebec , RMQ was full
    Intervention group: The group that received 80 mg Amp Methylprednisolon and 4 cc Amp Marcaine epidural injection with fluoroscopic guidance and then two weeks , four weeks, eight weeks after first dose injection , VAS, Oswestry, Quebec , RMQ was filled.
    #2
    Control group: the group that receive 80 mg methylprednisolon and 5 cc lidocaine gluteal trigger point injectionand two weeks , four weeks, eight weeks after first dose VAS, Oswestry, Quebec , RMQ was full
    Control group: The group that received injection of 80 mg Methylprednisolon amp and 5 cc of lidocaine amp in gluteal trigger points, then two weeks, four weeks and eight weeks after first dose, VAS, Oswestry, Quebec, RMQ questionnaires were filled.

  • Recruitment centers

    #1
    Name of recruitment center - English: Emam reza rehabilitation clinic
    Name of recruitment center - Persian: کلینیک توانبخشی امام رضا
    Full name of responsible person - English: Mani Ramzi
    Full name of responsible person - Persian: مانی رمزی
    Street address - English: Namazi square
    Street address - Persian: میدان نمازی
    City - English: shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 714737-71348
    Phone: +98 71 3212 7700
    Fax:
    Email: motahari@sums.ac.ir
    Web page address:
    Name of recruitment center - English: Emam reza rehabilitation clinic
    Name of recruitment center - Persian: کلینیک توانبخشی امام رضا
    Full name of responsible person - English: Mani Ramzi
    Full name of responsible person - Persian: مانی رمزی
    Street address - English: Namazi square
    Street address - Persian: میدان نمازی
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 714737-71348
    Phone: +98 71 3212 7700
    Fax:
    Email: motahari@sums.ac.ir
    Web page address:
    #2
    Name of recruitment center - English: Rajaee hospital
    Name of recruitment center - Persian: بیمارستان رجایی
    Full name of responsible person - English: Amirreza mesbahi
    Full name of responsible person - Persian: امیررضا مصباحی
    Street address - English: chamran Blvd
    Street address - Persian: بلوار چمران
    City - English: shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 7194815711
    Phone: +98 71 3636 4001
    Fax:
    Email: Rajaeehospital@sums.ac.ir
    Web page address:
    Name of recruitment center - English: Rajaee hospital
    Name of recruitment center - Persian: بیمارستان رجایی
    Full name of responsible person - English: Amirreza mesbahi
    Full name of responsible person - Persian: امیررضا مصباحی
    Street address - English: Chamran Blvd
    Street address - Persian: بلوار چمران
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 7194815711
    Phone: +98 71 3636 4001
    Fax:
    Email: Rajaeehospital@sums.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: دکتر قاسمی
    Full name of responsible person - Persian: Dr ghasemi
    Street address - English: Khalili Aveno, front of maaref school
    Street address - Persian: خیابان خلیلی روبروی اموزشگاه معارف
    City - English: shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 7134814336
    Phone: +98 71 3628 1506
    Fax:
    Email: Info@sums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr Ghasemi
    Full name of responsible person - Persian: دکتر قاسمی
    Street address - English: Khalili Aveno, front of Maaref school
    Street address - Persian: خیابان خلیلی روبروی اموزشگاه معارف
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 7134814336
    Phone: +98 71 3628 1506
    Fax:
    Email: Info@sums.ac.ir
    Web page address:

  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Sana sadat Khoshnazar
    Full name of responsible person - Persian: سانا سادات خوش نظر
    Position - English: Resident
    Position - Persian: رزیدنت
    Latest degree: med_doctor
    Area of specialty/work: 59
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: NO 6,Baharan Aveno , Maaliabad Blvd
    Street address - Persian: بلوار معالی اباد خیابان بهاران و کوچه شماره 6
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7184747811
    Phone: +98 71 3648 6787
    Mobile: +98 913 143 4549
    Fax:
    Email: Khoshnazar31@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Sana Sadat Khoshnazar
    Full name of responsible person - Persian: سانا سادات خوش نظر
    Position - English: Resident
    Position - Persian: رزیدنت
    Latest degree: med_doctor
    Area of specialty/work: 59
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: NO 6,Baharan Aveno , Maaliabad Blvd
    Street address - Persian: بلوار معالی اباد خیابان بهاران و کوچه شماره 6
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7184747811
    Phone: +98 71 3648 6787
    Mobile: +98 913 143 4549
    Fax:
    Email: Khoshnazar31@yahoo.com
    Web page address:

  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Sana sadat Khoshnazar
    Full name of responsible person - Persian: سانا سادات خوش نظر
    Position - English: Resident
    Position - Persian: رزیدنت
    Latest degree: med_doctor
    Area of specialty/work: 59
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: NO 6, Baharan Ave , Maaliabad Blvd
    Street address - Persian: بلوار معالی اباد خیابان بهاران کوچه شماره 6
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7184747811
    Phone: +98 71 3648 6787
    Mobile: +98 913 143 4549
    Fax:
    Email: khoshnazar31@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Sana Sadat Khoshnazar
    Full name of responsible person - Persian: سانا سادات خوش نظر
    Position - English: Resident
    Position - Persian: رزیدنت
    Latest degree: med_doctor
    Area of specialty/work: 59
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: NO 6, Baharan Ave , Maaliabad Blvd
    Street address - Persian: بلوار معالی اباد خیابان بهاران کوچه شماره 6
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7184747811
    Phone: +98 71 3648 6787
    Mobile: +98 913 143 4549
    Fax:
    Email: khoshnazar31@yahoo.com
    Web page address:

  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Sana sadat Khoshnazar
    Full name of responsible person - Persian: سانا سادات خوش نظر
    Position - English: Resident
    Position - Persian: رزیدنت
    Latest degree: med_doctor
    Area of specialty/work: 59
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: NO 6 , Baharan Ave, Maaliabad Blvd
    Street address - Persian: بلوار معالی اباد خیابان بهاران کوچه 6
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7184747811
    Phone: +98 71 3648 6787
    Mobile: +98 913 143 4549
    Fax:
    Email: Khoshnazar31@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Sana Sadat Khoshnazar
    Full name of responsible person - Persian: سانا سادات خوش نظر
    Position - English: Resident
    Position - Persian: رزیدنت
    Latest degree: med_doctor
    Area of specialty/work: 59
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: NO 6 , Baharan Ave, Maaliabad Blvd
    Street address - Persian: بلوار معالی اباد خیابان بهاران کوچه 6
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7184747811
    Phone: +98 71 3648 6787
    Mobile: +98 913 143 4549
    Fax:
    Email: Khoshnazar31@yahoo.com
    Web page address:

Protocol summary

Study aim
A comparison between effectiveness of gluteal trigger points injection with epidural steroid injection in lumbosacral canal stenosis patients
Design
the research is a randomize double blind clinical trial
Settings and conduct
The patients who had lumbosacral canal stenosis were selected from Emam Reza clinic and Rajaee hospital, then patients were divided into two groups and after obtaining written consent the study was begun. In the control group, steroid was injected into epidural, and in the intervention group, steroid was injected in the gluteal trigger points. Then its effects on reducing patients' pain and improving function were measured.
Participants/Inclusion and exclusion criteria
Exclusion criterria: Infection involving lumbar spinal (brucella), Diabetes mellitus, Rhumatological disorder(lupuse, gout), BMI more than 42 , Pregnancy, Malignancy, Liver disease, History of allergies, Malnutrition, Peripheral neuropathy, Bleeding disorder, Galactosemia, Radiculopathy. Inclusion criteria: Age: 40-75 years old, Being diagnosis with lumbar canal stenosis accordining to MRI or EDX, Complaining low back pain , psudoclaudication ,parestesia that no responsed to conservative treatment , Sex:male or female
Intervention groups
Group1: received an injection of steroid into gluteal trigger points. Group 2: received steroid epidural injection under fluoroscopic guide.
Main outcome variables
pain, activity of daily living

General information

Reason for update
1-Date transfer: Due to the delay in the acceptance and approval process and we expected a shorter time, we started the sick time earlier. 2. Being blind on both sides due to a typographical error
Acronym
IRCT registration information
IRCT registration number: IRCT20190802044411N1
Registration date: 2020-11-26, 1399/09/06
Registration timing: prospective

Last update: 2021-05-20, 1400/02/30
Update count: 1
Registration date
2020-11-26, 1399/09/06
Registrant information
Name
Sana Khoshnazar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3875 2488
Email address
khoshnazar31@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2022-03-10, 1400/12/19
Actual recruitment start date
2020-11-27, 1399/09/07
Actual recruitment end date
2021-03-18, 1399/12/28
Trial completion date
2021-05-14, 1400/02/24
Scientific title
A comparison between effectiveness of gluteal trigger injection with epidural steroid injection in lumbosacral canal stenosis patients
Public title
Gluteal trigger point injection in lumbosacral canal stenosis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age : 40 to75 years old Being diagnosis with lumbar canal stenosis according to mri or edx Complaining low back pain , psudoclaudication , parestesia that no responsed to conservative treatment Gender: male or female
Exclusion criteria:
Infection involving lumbar spinal (brucella) Diabetes mellitus Rhumatological disorder(lupuse, gout) BMI more than 42 Pregnancy Malignancy Liver disease sensitivity reaction to test drug Malnutrition Peripheral neuropathy Bleeding disorder Galactosemia Radiculopathy
Age
From 40 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 50
Actual sample size reached: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Complete randomized block design with random allocation software was used for randomization and the list of patients was prepared by a computer with the same block length and the secretary divided the patients based on the list of patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
clinical caregiver: we taught the caregiver how to complete the questionnaire. this person was not aware of the allocation to groups. The outcome assessor who completed the questionnaires was not aware of the group allocation. Data analyzer: Questionnaires were finally given to a person to review the information. This person does not know any of the steps of the work, how groups were classified and the intervention performed.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
No.6, Baharan Ave , Maali abad Blvd
City
shiraz
Province
Fars
Postal code
7184747811
Approval date
2019-06-22, 1398/04/01
Ethics committee reference number
IR.SUMS.MED.REC.1398.221

Health conditions studied

1

Description of health condition studied
lumbosacral canal stenosis
ICD-10 code
M99.53
ICD-10 code description
Intervertebral disc stenosis of neural canal of lumbar region

Primary outcomes

1

Description
radicular low back pain
Timepoint
two weeks, four weeks, eight weeks
Method of measurement
Visual Analogue Scale

Secondary outcomes

1

Description
function of patient
Timepoint
two weeks, four weeks , eight weeks
Method of measurement
The Quebec Back Pain Disability Scale

Intervention groups

1

Description
Intervention group: The group that received 80 mg Amp Methylprednisolon and 4 cc Amp Marcaine epidural injection with fluoroscopic guidance and then two weeks , four weeks, eight weeks after first dose injection , VAS, Oswestry, Quebec , RMQ was filled.
Category
Rehabilitation

2

Description
Control group: The group that received injection of 80 mg Methylprednisolon amp and 5 cc of lidocaine amp in gluteal trigger points, then two weeks, four weeks and eight weeks after first dose, VAS, Oswestry, Quebec, RMQ questionnaires were filled.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam reza rehabilitation clinic
Full name of responsible person
Mani Ramzi
Street address
Namazi square
City
Shiraz
Province
Fars
Postal code
714737-71348
Phone
+98 71 3212 7700
Email
motahari@sums.ac.ir

2

Recruitment center
Name of recruitment center
Rajaee hospital
Full name of responsible person
Amirreza mesbahi
Street address
Chamran Blvd
City
Shiraz
Province
Fars
Postal code
7194815711
Phone
+98 71 3636 4001
Email
Rajaeehospital@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Ghasemi
Street address
Khalili Aveno, front of Maaref school
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3628 1506
Email
Info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Sana Sadat Khoshnazar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
NO 6,Baharan Aveno , Maaliabad Blvd
City
Shiraz
Province
Fars
Postal code
7184747811
Phone
+98 71 3648 6787
Email
Khoshnazar31@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sana Sadat Khoshnazar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
NO 6, Baharan Ave , Maaliabad Blvd
City
Shiraz
Province
Fars
Postal code
7184747811
Phone
+98 71 3648 6787
Email
khoshnazar31@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sana Sadat Khoshnazar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
NO 6 , Baharan Ave, Maaliabad Blvd
City
Shiraz
Province
Fars
Postal code
7184747811
Phone
+98 71 3648 6787
Email
Khoshnazar31@yahoo.com

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
All available data can be shared after making people unidentifiable
When the data will become available and for how long
start access period one year after publishing the results
To whom data/document is available
everyone can access to this information
Under which criteria data/document could be used
if the information in this study helps to improve the science process
From where data/document is obtainable
khoshnazar31@yahoo.com 00989131434549
What processes are involved for a request to access data/document
after sending the desired message, all authors of the study will be consulted all information will be sent within a maximum of the three weeks if permited.
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