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General information
2018-12-21, 1397/09/30
2019-01-30, 1397/11/10
20182019-1201-2130 00:00:00
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
buttock pain or radicular pain of sciatic nerve
increase symptoms with sitting
tenderness in piriformis muscle
increase symptoms with tension-generated maneuver
buttock pain or radicular pain of 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
درد باسن یا محل عصب سیاتیک
افزایش علایم فرد با نشستن
تندرنس در محل پیریفورمیس
درد با مانورهایی که تنشن عضله را بالا ببرند افزایش می یابد
شدت درد بین 3 تا 6
12 هفته از شروع درد و علایم گذشته باشد
درد باسن یا درد رادیکولار عصب سیاتیک
افزایش علایم فرد با نشستن
تندرنس در محل پیریفورمیس
درد با مانورهایی که تنشن عضله را بالا ببرند افزایش می یابد
درد باسن یا محلدرد رادیکولار عصب سیاتیک افزایش علایم فرد با نشستن تندرنس در محل پیریفورمیس درد با مانورهایی که تنشن عضله را بالا ببرند افزایش می یابد شدت درد بین 3 تا 6 12 هفته از شروع درد و علایم گذشته باشد
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
contraindication of dry needling
history of vertebral or lower extremity surgery
pregnancy
hip arthritis or pain
lumbar discopathy or instability
contraindication of dry needling trunk andhistory of vertebral or 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
موارد ممنوعیت سوزن خشک
سابقه جراحی در ستون فقرات و اندام های تحتانی
وجود اختلالات اندام تحتانی که در راه رفتن موثر می باشد
حاملگی
درد یا آرتروز هیپ
اختلالات دیسک های کمری و یا بی ثباتی مهرهای کمری
انحراف بیش از حد زانو به داخل یا خارج
قوس یا صافی بیش از حد پا
موارد ممنوعیت سوزن خشک
سابقه جراحی در ستون فقرات و اندام های تحتانی
حاملگی
درد یا آرتروز هیپ
اختلالات دیسک های کمری و یا بی ثباتی مهرهای کمری
موارد ممنوعیت سوزن خشک سابقه جراحی در ستون فقرات و اندام های تحتانی وجود اختلالات اندام تحتانی که در راه رفتن موثر می باشد حاملگی درد یا آرتروز هیپ اختلالات دیسک های کمری و یا بی ثباتی مهرهای کمری انحراف بیش از حد زانو به داخل یا خارج قوس یا صافی بیش از حد پا
Primary outcomes
#1
range of motion
pain
range of motionpain
دامنه حرکتی
درد
دامنه حرکتیدرد
by goniometery
visual analog scale
by goniometeryvisual analog scale
با استفاده از گونیامتری
سنجش دیداری درد
با استفاده از گونیامتریسنجش دیداری درد
#2
pain
empty
pain
درد
empty
درد
Before first intervention, 72 hours and 7th days after the last treatment session
empty
Before first intervention, 72 hours and 7th days after the last treatment session
قبل از اولین مداخله، 72 ساعت و هفت روز پس از آخرین جلسه درمانی
empty
قبل از اولین مداخله، 72 ساعت و هفت روز پس از آخرین جلسه درمانی
visual analog scale
empty
visual analog scale
سنجش دیداری درد
empty
سنجش دیداری درد
Secondary outcomes
#1
empty
internal and external range of motion of hip joint
internal and external range of motion of hip joint
empty
دامنه حرکتی چرخش داخلی و خارجی مفصل هیپ
دامنه حرکتی چرخش داخلی و خارجی مفصل هیپ
empty
Before first intervention, 72 hours and 7th days after the last treatment session
Before first intervention, 72 hours and 7th days after the last treatment session
empty
قبل از اولین مداخله، 72 ساعت و هفت روز پس از آخرین جلسه درمانی
قبل از اولین مداخله، 72 ساعت و هفت روز پس از آخرین جلسه درمانی
empty
by goniometry
by goniometry
empty
با استفاده از روش گونیامتری
با استفاده از روش گونیامتری
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:2019-01-16, 1397/10/26
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
2019-01-30, 1397/11/10
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 pain or radicular pain of sciatic nerve
increase symptoms with sitting
tenderness in piriformis muscle
increase symptoms with tension-generated maneuver
Exclusion criteria:
contraindication of dry needling
history of vertebral or lower extremity surgery
pregnancy
hip arthritis or pain
lumbar discopathy or instability
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
pain
Timepoint
Before first intervention, 72 hours and 7th days after the last treatment session
Method of measurement
visual analog scale
Secondary outcomes
1
Description
lower extremity kinematic
Timepoint
before first intervention and 72 hours after last treatment session
Method of measurement
motion analysis instrument
2
Description
pain pressure threshold
Timepoint
Before first intervention, 72 hours and 7th days after the last treatment session
Method of measurement
algometery
3
Description
disability
Timepoint
Before first intervention, 72 hours and 7th days after the last treatment session
Method of measurement
oswestry questionnaire
4
Description
internal and external range of motion of hip joint
Timepoint
Before first intervention, 72 hours and 7th days after the last treatment session
Method of measurement
by goniometry
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)
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
The total data from this study, including demographic information, primary and secondary outcomes are shared after participant being unidentified.
When the data will become available and for how long
The start of the access period will be without a time limit from March of 2019.
To whom data/document is available
The data from this study will only be available to researchers at academic institutions.
Under which criteria data/document could be used
The data from this study will be available for use in secondary or review articles.
From where data/document is obtainable
It will be possible for the researchers to access the documentation by email with a personal page on the site
.E-mail address: pt.taba.a@gmail.com
Researchgate address: https://www.researchgate.net/profile/Abbas_Tabatabaiee
What processes are involved for a request to access data/document
All requests will be reviewed and answered within a maximum of 3 weeks.