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Comparison of the combined gluteus medius and quadratus lumborum dry needling & exercise with exercise alone on knee joint pain and function in female athletes with patellofemoral pain syndrome

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History
# Registration date Revision Id
2 2018-09-01, 1397/06/10 58436
1 2018-08-02, 1397/05/11 54977
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  • Protocol summary

    دو گروه موازی تصافی شده و یک سویه کور می باشد
    دو گروه موازی تصادفی شده و یک سویه کور می باشد
    Variables including pain intensity, function via Kujula questionnaire, functional step down test, pain pressure threshold (PPT) and balance via y balance test will be measured for each patient in first and 8th sessions and 2 weeks after the intervention
    Pain intensity
    متغیر های شدت درد، آستانه درد، عملکرد بیماران با استفاده از پرسشنامه کاجالا، تست عملکردی پایین آمدن از پله، و تعادل بیماران با استفاده از تست تعادل ستاره ای برای هر بیمار در جلسه اول و هشتم و 2 هفته بعد از مداخله اندازه گیری میشود.
    شدت درد

  • General information

    1
    1
    2018-07-05, 1397/04/14
    2018-08-05, 1397/05/14
    2018-08-23, 1397/06/01
    2018-11-22, 1397/09/01
    single blind, the participants are not aware of the intervention and the group
    single blind, the assessor are not aware of the group
    یک سو کور و شرکت کنندگان از مداخله و گروه مطلع نیستند
    یک سو کور و ارزیابی کنندگان از گروه مطلع نیستند

  • Intervention groups

    #1
    Control group: first week: Stretching exercises for quadriceps, hamstring (2set 15 repetition, 10 second hold); quadriceps setting in 10 degree terminal knee extension(3set 10 repetition),second week:sideling straight leg raises and hip abductors and external rotator strengthening exercise (Clamshells)(3 set, 15 repetition).third week: plank, side plank (3set 20 repetition). Fourth week: minisquat، minilung، single leg stance step down (Stairs with height 18 cm) (3set 25 repetition)
    Control group: Exercise progresively, first week: Stretching exercises for quadriceps, hamstring (2set 15 repetition, 10 second hold); quadriceps setting in 10 degree terminal knee extension(3set 10 repetition),second week:sideling straight leg raises and hip abductors and external rotator strengthening exercise (Clamshells)(3 set, 15 repetition).third week: plank, side plank (3set 20 repetition). Fourth week: minisquat، minilung، single leg stance step down (Stairs with height 18 cm) (3set 25 repetition)
    گروه کنترل: هفته اول :تمرینات کششی عضلات کوادریسپس, همسترینگ, (2ست با 15 تکرار و 10 ثانیه نگه داشتن). تمرینات انقباض ایزومتریک عضله چهار سر ران، در 10 درجه انتهایی اکستنشن زانو (3 ست با 10 تکرار)، هفته دوم: SLR جانبی را در وضعیت خوابیده به پهلو Clamshells در وضعیت خوابیده به پهلو ) external rotation 3 ست با 15 تکرار)، هفته سوم:پلانک، پلانک جانبی(3ست با 20 تکرار)، هفته چهارم: minisquat، minilung، single leg stance step down پله با ارتفاع18cm(3ست با 25 تکرار)
    گروه کنترل: تمرینات به صورت پیشرونده, هفته اول :تمرینات کششی عضلات کوادریسپس, همسترینگ, (2ست با 15 تکرار و 10 ثانیه نگه داشتن). تمرینات انقباض ایزومتریک عضله چهار سر ران، در 10 درجه انتهایی اکستنشن زانو (3 ست با 10 تکرار)، هفته دوم: SLR جانبی را در وضعیت خوابیده به پهلو Clamshells در وضعیت خوابیده به پهلو ) external rotation 3 ست با 15 تکرار)، هفته سوم:پلانک، پلانک جانبی(3ست با 20 تکرار)، هفته چهارم: minisquat، minilung، single leg stance step down پله با ارتفاع18cm(3ست با 25 تکرار)

  • Recruitment centers

    #1
    Name of recruitment center - English: Physiotherapy clinic of Shiraz School of Rehabilitation
    Name of recruitment center - Persian: کلینیک فیزیوتراپی دانشکده توانبخشی شیراز
    Full name of responsible person - English: hanieh zarei
    Full name of responsible person - Persian: هانیه زارعی
    Street address - English: NO.32, Abiverdi 1 Avenue, Chamran Blvd, Shiraz
    Street address - Persian: شیراز، بلوار چمران، خیابان ابیوردی یک، پلاک 32
    City - English: shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 7196744414
    Phone: +98 71 1626 1081
    Fax:
    Email: hanizareipt@gmail.com
    Web page address:
    Name of recruitment center - English: Physiotherapy clinic of Shiraz School of Rehabilitation
    Name of recruitment center - Persian: کلینیک فیزیوتراپی دانشکده توانبخشی شیراز
    Full name of responsible person - English: Hanieh zarei
    Full name of responsible person - Persian: هانیه زارعی
    Street address - English: NO.32, Abiverdi 1 Avenue, Chamran Blvd, Shiraz
    Street address - Persian: شیراز، بلوار چمران، خیابان ابیوردی یک، پلاک 32
    City - English: shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 7196744414
    Phone: +98 71 1626 1081
    Fax:
    Email: hanizareipt@gmail.com
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Gholamreza Hatam
    Full name of responsible person - Persian: دکتر غلامرضا حاتم
    Street address - English: Shiraz University of Medical Sciences Building, Zand Street,shiraz
    Street address - Persian: شیراز خیابان زند, ساختمان دانشگاه علوم پزشکی شیراز
    City - English: shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 7196744414
    Phone: +98 71 1626 1081
    Fax:
    Email: piroozis@sums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Basir Hashemi
    Full name of responsible person - Persian: دکتر بصیر هاشمی
    Street address - English: Shiraz University of Medical Sciences Building, Zand Street,shiraz
    Street address - Persian: شیراز خیابان زند, ساختمان دانشگاه علوم پزشکی شیراز
    City - English: shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 7196744414
    Phone: +98 71 1626 1081
    Fax:
    Email: piroozis@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: hanieh zarei
    Full name of responsible person - Persian: هانیه زارعی
    Position - English: Master science student of Physical Therapy
    Position - Persian: دانشجوی ارشد فیزیوتراپی
    Latest degree: bachelor
    Area of specialty/work: 68
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: NO.32, Abiverdi 1 Avenue, Chamran Blvd, Shiraz
    Street address - Persian: شیراز، بلوار چمران، خیابان ابیوردی یک، پلاک 32
    City - English: shiraz
    City - Persian: شیراز
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7196744414
    Phone: +7 136231831
    Mobile: +98 937 774 7389
    Fax:
    Email: hanizareipt@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Hanieh zarei
    Full name of responsible person - Persian: هانیه زارعی
    Position - English: Master science student of Physical Therapy
    Position - Persian: دانشجوی ارشد فیزیوتراپی
    Latest degree: bachelor
    Area of specialty/work: 68
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: NO.32, Abiverdi 1 Avenue, Chamran Blvd, Shiraz
    Street address - Persian: شیراز، بلوار چمران، خیابان ابیوردی یک، پلاک 32
    City - English: shiraz
    City - Persian: شیراز
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7196744414
    Phone: +7 136231831
    Mobile: +98 937 774 7389
    Fax:
    Email: hanizareipt@gmail.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: dr soraya piroozi
    Full name of responsible person - Persian: دکتر ثریا پیروزی
    Position - English: PhD of Physiotherapy
    Position - Persian: دکترای فیزیوتراپی
    Latest degree: phd
    Area of specialty/work: 68
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: NO.32, Abiverdi 1 Avenue, Chamran Blvd, Shiraz
    Street address - Persian: شیراز، بلوار چمران، خیابان ابیوردی یک، پلاک 32
    City - English: shiraz
    City - Persian: شیراز
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7196744414
    Phone: +98 71 1626 1081
    Mobile: +98 917 387 8391
    Fax:
    Email: piroozis@sums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr soraya piroozi
    Full name of responsible person - Persian: دکتر ثریا پیروزی
    Position - English: Phd of Physiotherapy
    Position - Persian: دکترای فیزیوتراپی
    Latest degree: phd
    Area of specialty/work: 68
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: NO.32, Abiverdi 1 Avenue, Chamran Blvd, Shiraz
    Street address - Persian: شیراز، بلوار چمران، خیابان ابیوردی یک، پلاک 32
    City - English: shiraz
    City - Persian: شیراز
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7196744414
    Phone: +98 71 1626 1081
    Mobile: +98 917 387 8391
    Fax:
    Email: piroozis@sums.ac.ir
    Web page address:

  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: hanieh zarei
    Full name of responsible person - Persian: هانیه زارعی
    Position - English: Master science student of Physical Therapy
    Position - Persian: دانشجوی ارشد فیزیوتراپی
    Latest degree: bachelor
    Area of specialty/work: 68
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: NO.32, Abiverdi 1 Avenue, Chamran Blvd, Shiraz
    Street address - Persian: شیراز، بلوار چمران، خیابان ابیوردی یک، پلاک 32
    City - English: shiraz
    City - Persian: شیراز
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7196744414
    Phone: +7 136231831
    Mobile: +98 937 774 7389
    Fax:
    Email: hanizareipt@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Hanieh zarei
    Full name of responsible person - Persian: هانیه زارعی
    Position - English: Master science student of Physical Therapy
    Position - Persian: دانشجوی ارشد فیزیوتراپی
    Latest degree: bachelor
    Area of specialty/work: 68
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: NO.32, Abiverdi 1 Avenue, Chamran Blvd, Shiraz
    Street address - Persian: شیراز، بلوار چمران، خیابان ابیوردی یک، پلاک 32
    City - English: shiraz
    City - Persian: شیراز
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7196744414
    Phone: +7 136231831
    Mobile: +98 937 774 7389
    Fax:
    Email: hanizareipt@gmail.com
    Web page address:

  • Sharing plan

    yes
    undecided
    yes
    undecided
    yes
    undecided
    yes
    undecided
    yes
    undecided
    yes
    undecided
    yes
    undecided
    empty
    The decision will be taken after the data is collected
    empty
    تصمیمات بعد از جمع اوری داده ها اتخاذ میگردد
    Comparison of the combined gluteus medius and quadratus lumborum dry needling & exercise with exercise alone on knee joint pain and function in female athletes with patellofemoral pain syndrome
    empty
    مقایسه تاثیر اعمال سوزن خشک عضلات گلوتئوس مدیوس و کوادراتوس لومباروم توأم با تمرین درمانی و تمرین درمانی به تنهایی بر درد و عملکرد زانوی زنان ورزشکار مبتلا به سندرم درد مفصل کشکی رانی
    empty
    13th of july Until late August
    empty
    13تیر ماه 97 تا اواخر مرداد
    empty
    researcher
    empty
    محقق
    empty
    Study and research
    empty
    مطالعه و پژوهش
    empty
    shiraz school of rehabilitation sciences
    empty
    دانشکده توانبخشی شیراز
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    therapeutic
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    درمانی
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Protocol summary

Study aim
The purpose of this study is to evaluate the effect of the effect of gluteus medius and quadratus lumborum muscle dry needling combined with therapeutic exercises on pain intensity, Pain threshold, function and balance in female athletes with patellofemoral pain syndrome.
Design
Two arm parallel group randomised trial with single-blind
Settings and conduct
In this clinical trial, individuals are included in the study if they are eligible and randomly assigned to one of the two intervention and control groups (each group of 20) using the Randomizer software
Participants/Inclusion and exclusion criteria
Women athletic patients with patellofemoral pain syndrome complaining gradual anterior knee pain during last 3 months and age between 18 to 45 years old are included. The patients with any previous knee trauma or other pathologies such as meniscus and ligament injuries are excluded.
Intervention groups
Minimal sample size for this study was determined as 20 patients in each group. Patients will randomly assigned either to control or intervention groups. Both groups will receive conventional physical therapy exercises for patellofemoral pain syndrome during 4 weeks (8 sessions), while the intervention group will receive gluteus medius and quadratus lumborum muscle dry needling.
Main outcome variables
Pain intensity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120411009440N20
Registration date: 2018-08-02, 1397/05/11
Registration timing: prospective

Last update: 2018-09-04, 1397/06/13
Update count: 1
Registration date
2018-08-02, 1397/05/11
Registrant information
Name
Soraya Pirouzi
Name of organization / entity
School of Rehabilitation Sciences, Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1626 5108
Email address
piroozis@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-05, 1397/05/14
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the combined gluteus medius and quadratus lumborum dry needling & exercise with exercise alone on knee joint pain and function in female athletes with patellofemoral pain syndrome
Public title
The effect of gluteus medius and quadratus lumborum dry needling in patients with patellofemoral pain syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 18 to 45 years old with unilateral or bilateral patellofemoral pain syndrome; anterior or retropatellar knee pain during at least 2 following activities: prolonged sitting, ascending or descending stair,squatting, kneeling, jumping and running; pain on palpation of medial and lateral patellar facets and positive patellar grind test; an insidious onset of symptoms not related to trauma for the last 3 months; Kujula scores less than 85 out of 100; numeric rate scale scores ranging 3 to 10 during last week. having trigger point in the gluteus medius muscle in the affected side and quadratos lumbar muscle in the non-affected side
Exclusion criteria:
Other knee joint pathologies such as meniscus and ligament injuries, osteoarthritis and tendon impairments; patellar subluxations or dislocations; Sinding-Larsen disease;Osgood–Schlatter disease; pelica syndrome;ankle and knee injury; hip joint pathologies such as ligament injuries, osteoarthritis and tendon impairments; subluxations or dislocations and hip injury; referral pain from other joints including lumbar spine, hip and sacroiliac joints and spinal fractures; LBP without source of myofascial; any pain during sitting such as Coccydynia; previous knee surgery; Structural and biomechanical problems such as: Varus and Valgus knee; overweight 32< BMI Prohibition the use of dry needles such as:metabolic diseases such as diabetes, rheumatic diseases and neuromuscular diseases; pregnancy; Respiratory and peripheral vascular disease, cancer and any malignancy; Immune deficiency; Menstruation; needle phobia; Hemorrhagic diseases and the use of anticoagulant drugs; liver and kidney disease
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization tool:Statistical software
Blinding (investigator's opinion)
Single blinded
Blinding description
single blind, the assessor are not aware of the group
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
Zand Blvd., Central Building of Shiraz University of Medical Sciences
City
shiraz
Province
Fars
Postal code
713451978
Approval date
2018-07-04, 1397/04/13
Ethics committee reference number
IR.SUMS.REC.1397.326

Health conditions studied

1

Description of health condition studied
Patellofemoral disorders
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain threshold
Timepoint
first and 8th sessions and 2 weeks after the intervention
Method of measurement
algometry

2

Description
Pain intensity
Timepoint
first and 8th sessions and 2 weeks after the intervention
Method of measurement
Numeric Rate Scale (NRS)

3

Description
Functional steping
Timepoint
first and 8th sessions and 2 weeks after the intervention
Method of measurement
Step down test

4

Description
function
Timepoint
first and 8th sessions and 2 weeks after the intervention
Method of measurement
kujula questionnaire

5

Description
balance
Timepoint
first and 8th sessions and 2 weeks after the intervention
Method of measurement
Y-Balance Test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:The same as control group plus gluteus medius and quadratus lumborum dry needling for 4 sessions , are given over a period of four weeks one session per weeks.The needle technique is fast in and out into the muscle tight band in three times
Category
Rehabilitation

2

Description
Control group: Exercise progresively, first week: Stretching exercises for quadriceps, hamstring (2set 15 repetition, 10 second hold); quadriceps setting in 10 degree terminal knee extension(3set 10 repetition),second week:sideling straight leg raises and hip abductors and external rotator strengthening exercise (Clamshells)(3 set, 15 repetition).third week: plank, side plank (3set 20 repetition). Fourth week: minisquat، minilung، single leg stance step down (Stairs with height 18 cm) (3set 25 repetition)
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Physiotherapy clinic of Shiraz School of Rehabilitation
Full name of responsible person
Hanieh zarei
Street address
NO.32, Abiverdi 1 Avenue, Chamran Blvd, Shiraz
City
shiraz
Province
Fars
Postal code
7196744414
Phone
+98 71 1626 1081
Email
hanizareipt@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Basir Hashemi
Street address
Shiraz University of Medical Sciences Building, Zand Street,shiraz
City
shiraz
Province
Fars
Postal code
7196744414
Phone
+98 71 1626 1081
Email
piroozis@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Hanieh zarei
Position
Master science student of Physical Therapy
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
NO.32, Abiverdi 1 Avenue, Chamran Blvd, Shiraz
City
shiraz
Province
Fars
Postal code
7196744414
Phone
+7 136231831
Email
hanizareipt@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr soraya piroozi
Position
Phd of Physiotherapy
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
NO.32, Abiverdi 1 Avenue, Chamran Blvd, Shiraz
City
shiraz
Province
Fars
Postal code
7196744414
Phone
+98 71 1626 1081
Email
piroozis@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hanieh zarei
Position
Master science student of Physical Therapy
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
NO.32, Abiverdi 1 Avenue, Chamran Blvd, Shiraz
City
shiraz
Province
Fars
Postal code
7196744414
Phone
+7 136231831
Email
hanizareipt@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
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