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Protocol summary
بیماران توسط جدول اعداد به دو گروه تقسیم خواهند شد. گروه اول ، طی 6 جلسه سوزن خشک عضله ایلیوپسوآس را دریافت خواهند کرد. در عین حال از درمان مرسوم فیزیوتراپی نیز بهره مند می گردند ولی گروه کنترل فقط از درمان مرسوم فیزیوتراپی استفاده خواهد کرد.محل انجام طرح کلینیک فیزیوتراپی بیمارستان اسدآبادی می باشد.
بیماران توسط جدول اعداد به دو گروه تقسیم خواهند شد. گروه اول، طی 6 جلسه سوزن خشک عضله ایلیوپسوآس را دریافت خواهند کرد. در عین حال از درمان مرسوم فیزیوتراپی نیز بهره مند می گردند ولی گروه کنترل فقط از درمان مرسوم فیزیوتراپی استفاده خواهد کرد.محل انجام طرح کلینیک فیزیوتراپی بیمارستان اسدآبادی می باشد.
بیماران توسط جدول اعداد به دو گروه تقسیم خواهند شد. گروه اول، طی 6 جلسه سوزن خشک عضله ایلیوپسوآس را دریافت خواهند کرد. در عین حال از درمان مرسوم فیزیوتراپی نیز بهره مند می گردند ولی گروه کنترل فقط از درمان مرسوم فیزیوتراپی استفاده خواهد کرد.محل انجام طرح کلینیک فیزیوتراپی بیمارستان اسدآبادی می باشد.
General information
2023-10-23, 1402/08/01
2024-10-22, 1403/08/01
20232024-10-2322 00:00:00
2024-01-21, 1402/11/01
2025-03-05, 1403/12/15
20242025-0103-2105 00:00:00
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I want to change the expected start date of the patient intake to 2024-10-22 due to the university's inability to solve the problems encountered in order to prepare the tools needed to measure this plan, and subsequently change the expected end date of the patient intake to 2025-03-05.
I want to change the expected start date of the patient intake to 2024-10-22 due to the university's inability to solve the problems encountered in order to prepare the tools needed to measure this plan, and subsequently change the expected end date of the patient intake to 2025-03-05.
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خواستار تغییر تاریخ شروع بیمارگیری مورد انتظار به 1403/8/1 ، به دلیل عدم توانایی دانشگاه در حل مشکلات پیش آمده جهت تهیه ابزارهای مورد نیاز اندازه گیری این طرح، و متعاقبا تغییر تاریخ پایان بیمارگیری مورد انتظار به 1403/12/15 می باشم.
خواستار تغییر تاریخ شروع بیمارگیری مورد انتظار به 1403/8/1 ، به دلیل عدم توانایی دانشگاه در حل مشکلات پیش آمده جهت تهیه ابزارهای مورد نیاز اندازه گیری این طرح، و متعاقبا تغییر تاریخ پایان بیمارگیری مورد انتظار به 1403/12/15 می باشم.
تصادفی سازی توسط فردی خارج از تیم پژوهش با روش تخصیص موازی 1:1 انجام میشود که از یک برنامه تصادفی سازی کامپیوتری برای تخصیص شرکت کنندگان به گروه ها، با استفاده از بلوک های چهار و شش تایی استفاده می کند. سپس از پاکتهای مهر و موم شده مات استفاده کرده و با روش از پیش برچسب گذاری شده با حروف A و ، پنهان سازی در تخصیص گروه ها را انجام می دهد.) در دو گروه کنترل و مداخله قرار خواهند
تصادفیسازی توسط فردی خارج از تیم تحقیقاتی با روش تخصیص موازی 1:1 انجام میشود که از یک برنامه تصادفیسازی رایانهای برای تخصیص شرکتکنندگان به گروهها با استفاده از بلوکهای چهار و شش استفاده میکند. سپس از پاکت های مهر و موم شده مات استفاده می کند و تخصیص گروه ها را با روشی که از قبل با حروف A و B مشخص شده پنهان می کند. در دو گروه کنترل و مداخله قرار می گیرند.
تصادفیسازی توسط فردی خارج از تیم پژوهشتحقیقاتی با روش تخصیص موازی 1:1 انجام میشودمیشود که از یک برنامه تصادفیسازی کامپیوتریرایانهای برای تخصیص شرکتکنندگان به گروهها، با استفاده از بلوکهای چهار و شش تایی استفاده میکند. سپس از پاکتهایپاکت های مهر و موم شده مات استفاده کردهمی کند و تخصیص گروه ها را با روشروشی که از پیش برچسب گذاری شدهقبل با حروف A و ،B مشخص شده پنهان سازی در تخصیص گروه ها را انجام می دهدکند.) در دو گروه کنترل و مداخله قرار خواهندمی گیرند.
Recruitment centers
#1
Name of recruitment center - English: Asad Abadi hospital, physical therapy clinic
Name of recruitment center - Persian: کلینیک فیزیوتراپی، بیمارستان اسدآبادی
Full name of responsible person - English: Hakimeh Adigozali
Full name of responsible person - Persian: دکتر حکیمه آدی گوزلی
Street address - English: Bahar street, Asad Abadi hospital
Street address - Persian: خیابان بهار، بیمارستان اسدآبادی
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5166414766
Phone: +98 41 3280 1777
Fax:
Email: adigozalih@gmail.com
Web page address:
Name of recruitment center - English: Asad Abadi hospital, physical therapy clinic
Name of recruitment center - Persian: کلینیک فیزیوتراپی، بیمارستان اسدآبادی
Full name of responsible person - English: Hakimeh Adigozali
Full name of responsible person - Persian: دکتر حکیمه آدی گوزلی
Street address - English: Asad-Abadi hospital, Bahar avenue, Tabriz
Street address - Persian: تبریز، خیابان بهار، بیمارستان اسدآبادی
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5166414766
Phone: +98 41 3280 1777
Fax:
Email: adigozalih@gmail.com
Web page address:
Name of recruitment center - English: Asad Abadi hospital, physical therapy clinic Name of recruitment center - Persian: کلینیک فیزیوتراپی، بیمارستان اسدآبادی Full name of responsible person - English: Hakimeh Adigozali Full name of responsible person - Persian: دکتر حکیمه آدی گوزلی Street address - English: Bahar street, Asad-Abadi hospital, Bahar avenue, Tabriz Street address - Persian: تبریز، خیابان بهار، بیمارستان اسدآبادی City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: 5166414766 Phone: +98 41 3280 1777 Fax: Email: adigozalih@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: parviz shahabi
Full name of responsible person - Persian: پرویز شهابی
Street address - English: central building, tabriz university of medical sciences, university street, tabriz
Street address - Persian: تبریز، خیابان دانشگاه، دانشگاه علوم پزشکی تبریز، ساختمان مرکزی
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5166614766
Phone: +98 41 3337 6923
Fax:
Email: parvizshahabi@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Parviz Shahabi
Full name of responsible person - Persian: پرویز شهابی
Street address - English: Central building, Tabriz university of medical sciences, university street, Tabriz
Street address - Persian: تبریز، خیابان دانشگاه، دانشگاه علوم پزشکی تبریز، ساختمان مرکزی
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5166614766
Phone: +98 41 3337 6923
Fax:
Email: parvizshahabi@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: parviz shahabiParviz Shahabi Full name of responsible person - Persian: پرویز شهابی Street address - English: centralCentral building, tabrizTabriz university of medical sciences, university street, tabrizTabriz Street address - Persian: تبریز، خیابان دانشگاه، دانشگاه علوم پزشکی تبریز، ساختمان مرکزی City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: 5166614766 Phone: +98 41 3337 6923 Fax: Email: parvizshahabi@gmail.com Web page address:
Protocol summary
Study aim
Investigate the effect of dry needling on the trigger points of the iliopsoas muscle in patients with non-specific chronic back pain.
Design
Clinical trial with control group, with parallel groups, Tow-blinded, randomized, without phase on 40 patients, randomization allocation software was used for randomization
Settings and conduct
Patients will be divided into two groups by the table of numbers. The first group will receive dry needling of the iliopsoas muscle during 6 sessions. At the same time, they will also benefit from conventional physiotherapy treatment, but the control group will only use conventional physiotherapy treatment. The location of the project will be at the Physiotherapy clinic of Asadabadi Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1) People between 30 and 65 years old
2) Chronic back pain that lasts 3 months or more
3) People with a disability score of >40 in the QBPDS questionnaire)
4) Not receiving any other physiotherapy treatment while participating in the study.
5) The presence of a trigger point in the iliopsoas muscle
Intervention groups
The intervention group includes patients with non-specific chronic back pain, whose conventional physical therapy includes continuous ultrasound treatment with a frequency of 1 MHz and intensity of 1.5 for 6 minutes, TENS burst electric current with a frequency of 2 Hz and diversion of 100 µs for 20 minutes, and the use of hot packs at the same time. Apply with current. Exercises are taught in the clinic under the supervision of a physiotherapist. 6 sessions of dry needling treatment are also done for them. The control group includes patients with non-specific chronic back pain who only receive conventional physiotherapy.
Main outcome variables
Pain; intensity in trigger points of Iliopsoas muscles; Intensity of back pain; Pressure threshold of trigger point pain; Functional disability
General information
Reason for update
I want to change the expected start date of the patient intake to 2024-10-22 due to the university's inability to solve the problems encountered in order to prepare the tools needed to measure this plan, and subsequently change the expected end date of the patient intake to 2025-03-05.
Acronym
IRCT registration information
IRCT registration number:IRCT20200215046499N4
Registration date:2023-09-24, 1402/07/02
Registration timing:prospective
Last update:2024-09-07, 1403/06/17
Update count:1
Registration date
2023-09-24, 1402/07/02
Registrant information
Name
Hakimeh Adigozali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 5359
Email address
adigozalih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-22, 1403/08/01
Expected recruitment end date
2025-03-05, 1403/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of iliopsoas muscle dry needling technique on the clinical symptoms of subject with non-specific low back Pain
Public title
Effect of dry needling technique of iliopsoas muscle
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People between 30 and 65 years old
Chronic back pain that lasts for 3 months or more
People with a disability score of >40 in the QBPDS Questionnaire)
Not receiving any other physiotherapy treatment while participating in the study
The presence of a trigger point in the muscle Iliposoas
Exclusion criteria:
Patients with sensory and/or coagulation disorders
History of spine surgery
Heart complications
Simultaneous severe disease of the central or peripheral nervous system, Epilepsy
Needle phobia
Serious pathologies
Specific back pain (for example, the presence of spinal canal stenosis, spondylolisthesis, tumors, etc.)
People who have contraindications for transcutaneous electrical stimulation (TENS) and (US) will be excluded
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done by someone outside the research team with a 1:1 parallel allocation method, which uses a computer randomization program to assign participants to groups, using blocks of four and six. Then he uses opaque sealed envelopes and hides the allocation of groups with the method pre-labeled with the letters A and B.) They will be placed in two control and intervention groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Double-blind, participants: In the control group, patients are told that routine physical therapy is the only treatment.
Outcome assessor: The person who assesses the patients does not know whether they belong to the control or intervention group
Data analyst: The person who evaluates the data of the two groups does not know whether they belong to the contr
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of medical sciiences
Street address
Faculty of Rehabilitation sciences, Tabriz University of medical sciences,29 Bahman Blvd, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Approval date
2023-09-04, 1402/06/13
Ethics committee reference number
IR.TBZMED.REC.1402.424
Health conditions studied
1
Description of health condition studied
Non-specific low back Pain
ICD-10 code
M54.5
ICD-10 code description
low back pain
Primary outcomes
1
Description
Pain intensity of trigger points
Timepoint
Before and after intervention
Method of measurement
Algometer
Secondary outcomes
1
Description
Pain intensity of back
Timepoint
Before and after intervention
Method of measurement
Numeric pain rating scale (NPRS)
2
Description
Intensity of depression and anxiety
Timepoint
Before and after intervention
Method of measurement
Hospital Anxiety and Depression Scale( HADS)
3
Description
Intensity of functional disability
Timepoint
Before and after intervention
Method of measurement
Quebec back pain disability scale(QBPDS)
4
Description
Pain pressure threshold of trigger points
Timepoint
Before and after intervention
Method of measurement
Algometer
Intervention groups
1
Description
Intervention group: In addition to receiving dry needling during 6 sessions (with a sterile dong bang needle with a size of 30*50 mm), they are included in the conventional physiotherapy treatment provided by the physiotherapist. People in the intervention group of the conventional treatment (as a modality It is possible to use continuous ultrasound with a frequency of 1 MHz and an intensity of 1.5 for 6 minutes (same side of the waist), using a burst TENS electric current with a frequency of 2 Hz and a diversion of 100 µs for 20 minutes, and using a hot pack simultaneously with the current. Also, sports exercises designed in the clinic are taught to the person under the supervision of a physiotherapist
Category
Rehabilitation
2
Description
Control group: People in the control group received conventional treatment (as a modality, continuous ultrasound with a frequency of 1 MHz and intensity of 1.5 for 6 minutes (same side of the back), use of TENS burst electric current with a frequency of 2 Hz and diversion of 100 µs for 20 minutes and using The hot pack is applied simultaneously with the current (76).Also, the person is taught the designed sports exercises in the clinic under the supervision of the physiotherapist.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Asad Abadi hospital, physical therapy clinic
Full name of responsible person
Hakimeh Adigozali
Street address
Asad-Abadi hospital, Bahar avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166414766
Phone
+98 41 3280 1777
Email
adigozalih@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
Central building, Tabriz university of medical sciences, university street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3337 6923
Email
parvizshahabi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Hakimeh adigozali
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of rehabilitation sciences, Tabriz university of medical sciences,29 Bahman Blvd
City
tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3337 5359
Email
Adigozalih@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hakimeh Adigozali
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of rehabilitation sciences, Tabriz university of medical sciences,29 Bahman Blvd
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 51 6661 6471
Email
Adigozalih@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hakimeh adigozali
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of rehabilitation sciences, Tabriz university of medical sciences,29 Bahman Blvd
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3337 5359
Email
Adigozalih@tbzmed.ac.ir
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
Not applicable
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