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The effect of dry needling technique on pain, disability and lower extremity kinematics during walking in patient with piriformis syndrome

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History
# Registration date Revision Id
4 2019-01-01, 1397/10/11 75524
3 2018-09-20, 1397/06/29 60862
2 2018-09-09, 1397/06/18 59150
1 2018-08-24, 1397/06/02 57202
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  • General information

    2018-08-21, 1397/05/30
    2018-08-27, 1397/06/05

  • Recruitment centers

    #1
    Name of recruitment center - English: Physiotherapy Laboratory, Faculty of Rehabilitation, Iran University of Medical Sciences
    Name of recruitment center - Persian: آزمایشگاه فیزیوتراپی دانشکده توانبخشی دانشگاه علوم پزشکی ایران
    Full name of responsible person - English: عباس طباطبایی
    Full name of responsible person - Persian: abbas tabatabaiee
    Street address - English: Tehran, Mirdamad, Madar Square, Shah Nazari St., madadkaran St., Faculty of Rehabilitation Sciences
    Street address - Persian: تهران، میرداماد، میدان مادر، خیابان شاه نظری، خیابان مددکاران، دانشکده علوم توانبخشی
    City - English: tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: ۱۳۴۸۷ - ۱۵۴۵۹
    Phone: +98 21 2222 2059
    Fax:
    Email: pt.taba.a@gmail.com
    Web page address:
    Name of recruitment center - English: Physiotherapy Cilinic, Faculty of Rehabilitation, Iran University of Medical Sciences
    Name of recruitment center - Persian: درمانگاه فیزیوتراپی دانشکده توانبخشی دانشگاه علوم پزشکی ایران
    Full name of responsible person - English: Abbas tabatabaiee
    Full name of responsible person - Persian: عباس طباطبایی
    Street address - English: Physical therapy cilinic, Faculty of rehabilitation sciences., Madadkaran St., Shahnazari St., Madar Squar, Mirdamad, Tehran
    Street address - Persian: تهران، میرداماد، میدان مادر، خیابان شاه نظری، خیابان مددکاران، دانشکده علوم توانبخشی، کلنیک فیزیوتراپی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: ۱۳۴۸۷ - ۱۵۴۵۹
    Phone: +98 21 2222 2059
    Fax:
    Email: pt.taba.a@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: اعظم بیات
    Full name of responsible person - Persian: azam bayat
    Street address - English: Tehran, Mirdamad, Madar Square, Shah Nazari St., madadkaran St., Faculty of Rehabilitation Sciences
    Street address - Persian: تهران، میرداماد، میدان مادر، خیابان شاه نظری، خیابان مددکاران، دانشکده علوم توانبخشی دانشگاه علوم پزشکی ایران
    City - English: tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: ۱۳۴۸۷ - ۱۵۴۵۹
    Phone: +98 21 2222 2059
    Fax:
    Email: kamyab.m@iums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: kazem malakouti
    Full name of responsible person - Persian: کاظم ملکوتی
    Street address - English: Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
    Street address - Persian: تهران، بزرگراه شهید همت، دانشگاه علوم پزشکی ایران
    City - English: tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: ۱۳۴۸۷ - ۱۵۴۵۹
    Phone: +98 21 2222 2059
    Fax:
    Email: malakoutik@yahoo.com
    Web page address:
    empty
    Yes
    Deputy of Research of Iran University of Medical Sciences
    Iran University of Medical Sciences
    معاونت پژوهشی دانشگاه علوم پزشکی ایران
    دانشگاه علوم پزشکی ایران

Protocol summary

Study aim
The aim of this study was to examine the therapeutic aspect of the effect of the dry needling method on the symptoms of piriformis syndrome due to the specialty of this technique. Also in this study, the effect of piriformis dry needling technique on the changes in the range of motion of the lower limb joints while walking and the degree of kinematic variability of the hip, knee and ankle joints are investigated.
Design
In this study, patients with piriformis syndrome were first examined for pain and motion analysis during walking. Then, subjects will be divide into treatment and control groups. In the treatment group, patients receive three sessions of dry needling in one week, and the control group will not receive treatment.after then both groups are re-evaluated.
Settings and conduct
This study is single-blinded trial and will be carried out in the Clinic of Physiotherapy, Faculty of Rehabilitation Sciences of Iran.
Participants/Inclusion and exclusion criteria
Inclusion criteria include pain in the buttocks or sciatica nerve, increased symptoms by sitting, tenderness at the the piriformis, tension-demand Maneuver increase symptoms. The patient's pain intensity between 3 to 6 and about atleast12 weeks from the onset of pain. exclusion criteria include contraindication of dry needling, pain in any lower limb joints, pregnancy, flat foot and limping .
Intervention groups
The study included two groups of control and treatment. In both groups, a preliminary assessment will be carried out. After that, the control group will not receive treatment for a week and then will assess.in control group after final assessment, physical therapy intervention will be done. the treatment group will receive dry needling technique, a three session per week on the piriformis muscle and under ultrasound and then re-evaluated.
Main outcome variables
pain; range of motion; kinematic variability; disability

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151026024729N2
Registration date: 2018-08-24, 1397/06/02
Registration timing: prospective

Last update: 2018-09-11, 1397/06/20
Update count: 3
Registration date
2018-08-24, 1397/06/02
Registrant information
Name
Abbas Tabatabaiee
Name of organization / entity
Iran University of Medical and Science
Country
Iran (Islamic Republic of)
Phone
+98 21 2253 4001
Email address
tabataba.a@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-27, 1397/06/05
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of dry needling technique on pain, disability and lower extremity kinematics during walking in patient with piriformis syndrome
Public title
The effect of dry needling technique on walking in subjects with piriformis syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
buttock or sciatic nerve location pain increase symptoms with sitting tenderness in piriformis muscle increase symptoms with tension-generated maneuver pain intensity between 3 to 6 12 weeks from the onset of pain and symptoms
Exclusion criteria:
contraindication of dry needling trunk and lower extremity surgery history any dysfunction or deviation that perturbed gait pregnancy hip arthritis or pain lumbar discopathy or instability excessive genuvalgum or varum excessive flat foot
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization using random block method is performed individually using sealed envelopes.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, evaluator do not know allocation and treatment effects.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2018-01-20, 1396/10/30
Ethics committee reference number
IR.IUMS.REC1396.9221342202

Health conditions studied

1

Description of health condition studied
piriformis syndrome
ICD-10 code
S74.0
ICD-10 code description
Injury of sciatic nerve at hip and thigh level

Primary outcomes

1

Description
range of motion
Timepoint
Before intervention and 72 hours after the last treatment session
Method of measurement
by motion analysis instrument

2

Description
kinematic variability
Timepoint
Before intervention and 72 hours after the last treatment session
Method of measurement
by motion analysis instrument

Secondary outcomes

1

Description
pain
Timepoint
Before intervention and 72 hours after the last treatment session
Method of measurement
visual analog scale

2

Description
pain pressure threshold
Timepoint
Before intervention and 72 hours after the last treatment session
Method of measurement
algometery

3

Description
disability
Timepoint
Before intervention and 72 hours after the last treatment session
Method of measurement
oswestry questionnaire

Intervention groups

1

Description
Control group: In this group, patients will not receive treatment for a week and after a week they will receive physiotherapy for the release of piriformis muscle.
Category
Rehabilitation

2

Description
Intervention group: In this group, people will be treated with dry needling. In this method, the needle is inserted into the piriformis muscle simultaneously with the help of an ultrasound apparatus, and it is rotated and returned for 60 seconds.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Physiotherapy Cilinic, Faculty of Rehabilitation, Iran University of Medical Sciences
Full name of responsible person
Abbas tabatabaiee
Street address
Physical therapy cilinic, Faculty of rehabilitation sciences., Madadkaran St., Shahnazari St., Madar Squar, Mirdamad, Tehran
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷ - ۱۵۴۵۹
Phone
+98 21 2222 2059
Email
pt.taba.a@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
kazem malakouti
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
tehran
Province
Tehran
Postal code
۱۳۴۸۷ - ۱۵۴۵۹
Phone
+98 21 2222 2059
Email
malakoutik@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Abbas tabatabaiee
Position
Ph.D Candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Faculty of rehabilitation sciences., Madadkaran St., shahnazari St., Madar Squar, Mirdamad, Tehran
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷ - ۱۵۴۵۹
Phone
+98 21 2222 2059
Email
pt.taba.a@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ismail ebrahimi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of rehabilitation sciences., Madadkaran St., shahnazari St., Madar Squar, Mirdamad, Tehran
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷ - ۱۵۴۵۹
Phone
+98 21 2222 2059
Email
dr_i_ebrahimi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abbas tabatabaiee
Position
Ph.D Candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Faculty of rehabilitation sciences., Madadkaran St., shahnazari St., Madar Squar, Mirdamad, Tehran
City
Tehran
Province
Tehran
Postal code
۱۳۴۸۷ - ۱۵۴۵۹
Phone
+98 21 2222 2059
Email
pt.ataba.a@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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