History
# Registration date Revision Id
2 2018-12-23, 1397/10/02 72040
1 2018-11-03, 1397/08/12 65729
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  • Protocol summary

    Effects of dry needling technique in treating the active trigger points of the upper trapezius muscle
    Comparison of the effects of two manual treatments separately in treating the active trigger points
    بررسی اثر تکنیک سوزن خشک در درمان نقاط ماشه ای فعال عضله ی ذوزنقه ای فوقانی
    مقایسه تاثیرات دو روش درمان دستی بصورت مجزا در درمان نقاط ماشه ای فعال
    Intervention group: Dry needlingTechnique , twice a week , For two weeks. Control group: There is no intervention.
    Intervention group 1: Instrument assisted soft tissue mobilization technique , twice a week , For 2 weeks. Intervention group 2: Dry needling , twice a week , For 2 weeks. Control group: There is no intervention.
    گروه مداخله : سوزن خشک ، 2 جلسه در هفته و به مدت 2 هفته. گروه کنترل: هیچ مداخله ای دریافت نمی کند.
    گروه مداخله اول: موبیلیزاسیون بافت نرم بوسیله ابزار ، 2 جلسه در هفته و به مدت 2 هفته. گروه مداخله دوم :سوزن خشک ، دو جلسه در هفته و به مدت 2 هفته. گروه کنترل: هیچ مداخله ای دریافت نمی کند.
  • General information

    50
    75
    Effects of dry needling technique (DN) on the active trigger points of the upper trapezius muscle
    Comparison of instrument assisted soft tissue mobilization technique (IASTM) with dry needling (DN) on the active trigger points of the upper trapezius muscle
    بررسی اثر تکنیک سوزن خشک بر روی نقاط ماشه ای فعال عضله ی ذوزنقه ای فوقانی
    بررسی مقایسه ای اثر تکنیک موبیلیزاسیون بافت نرم بوسیله ابزار و سوزن خشک بر روی نقاط ماشه ای فعال عضله ی ذوزنقه ای فوقانی
    Effects of dry needling technique (DN) in improving pain pressure threshold (PPT) , active cervical contra lateral flexion (ACCLF) , pain intensity (PI) and neck disability index (NDI) in patients with active trigger points of the upper trapezius muscle
    Comparison of the effectiveness of instrument assisted soft tissue mobilization technique (IASTM) with dry needling (DN) in improving pain pressure threshold (PPT) , active cervical contra lateral flexion (ACCLF) , pain intensity (PI) and neck disability index (NDI) in patients with active trigger points of the upper trapezius muscle
    تاثیر تکنیک سوزن خشک بر بهبود آستانه ی درد فشاری ، دامنه حرکتی فعال خم کردن طرفی گردن ، شدت درد و شاخص ناتوانی گردن در بیماران مبتلا به نقاط ماشه ای فعال در عضله ی ذوزنقه ای فوقانی
    مقایسه اثر بخشی تکنیک موبیلیزاسیون بافت نرم بوسیله ابزار با تکنیک سوزن خشک در بهبود آستانه ی درد فشاری ، دامنه حرکتی فعال خم کردن طرفی گردن ، شدت درد و شاخص ناتوانی گردن در بیماران مبتلا به نقاط ماشه ای فعال در عضله ی ذوزنقه ای فوقانی
    In this study, a sample of 50 people, 25 cards for intervention group and 25 cards for control group were considered and placed inside a sealed envelope that is non-transparent to draw then each patient takes one of the cards randomly and their group is identified and the generated sequence is recorded.
    In this study, a sample of 75 people, 25 cards for each intervention group and 25 cards for control group were considered and placed inside a sealed envelope that is non-transparent to draw then each patient takes one of the cards randomly and their group is identified and the generated sequence is recorded.
    در این مطالعه با حجم نمونه 50 نفر ، 25 کارت برای گروه مداخله و 25 کارت برای گروه شاهد در نظر گرفته شده و داخل یک پاکت مهر و موم شده و غیرشفاف برای قرعه کشی قرار می گیرد و سپس هر بیمار یکی از کارت ها را بصورت تصادفی برداشته و گروهش مشخص می شود و توالی ایجاد شده ثبت می شود.
    در این مطالعه با حجم نمونه 75 نفر ، 25 کارت برای هر گروه مداخله و 25 کارت برای گروه شاهد در نظر گرفته شده و داخل یک پاکت مهر و موم شده و غیرشفاف برای قرعه کشی قرار می گیرد و سپس هر بیمار یکی از کارت ها را بصورت تصادفی برداشته و گروهش مشخص می شود و توالی ایجاد شده ثبت می شود.
  • Intervention groups

    #1
    Intervention group:Dry needle technique is done using sterile needles and disposable Dong Bang with a length of 40 mm and a thickness of 0.25 mm.After the tight bundles are found in the upper trapezius muscle, the therapist inserts the needle at a 30-degree angle and inserts the needle out frequently and then again into another part of the trigger point, this procedure is repeated as long as no other local twitch response is felt. This technique is performed in 4 sessions and twice a week.
    Intervention group: In this technique is first step to increase blood flow and muscle tissue temperature for 5 minutes, superficial heat will be used and then using the myo-release tool, muscle tissue will be massaged for 5 minutes. The soft tissue mobilization technique is carried out using the myo-release tool No. 1, made in Iran. The tool is made of stainless steel. Immediately after massage, the therapist applies 3 passive stretches for 30 seconds on the muscle and this phase is completed by the 2nd 12th active muscle stretches by the patient herself and in the final stage, the patient performs the shoulder elevation as 2 sets of 15. This technique is performed in 4 sessions and twice a week.
    گروه مداخله:تکنیک سوزن خشک با استفاده از سوزن های استریل و یکبار مصرف دانگ بنگ به طول 40 میلی متر و ضخامت 0.25 میلی متر انجام می شود.پس از لمس مناسب باندهای سفت در عضله ذوزنقه ای فوقانی ، درمانگر سوزن را با زاویه 30 درجه وارد نقاط ماشه ای کرده و سوزن را به طور مکرر مقداری بیرون کشیده و مجددا به قسمت دیگری از نقطه ماشه ای وارد میکند ، این کار تا زمانی تکرار می شود که هیچ پاسخ پرشی موضعی دیگری احساس نشود. این تکنیک کلا در ۴ جلسه و هفته ای ۲ بار انجام می شود.
    گروه مداخله: درمرحله اول این تکنیک به منظور افزایش جریان خون و دمای بافت عضله به مدت 5 دقیقه از گرمای سطحی استفاده خواهد شد وسپس با استفاده ازابزار میو-ریلیز، بافت عضله به مدت 5 دقیقه ماساژ داده خواهد شد.تکنیک موبیلیزاسیون بافت نرم بوسیله ابزار میو- ریلیز شماره 1 ، ساخت ایران انجام می شود.ابزار از جنس استیل ضد زنگ می باشد.بلافاصله پس از ماساژ،درمانگر 3 کشش غیرفعال به مدت 30 ثانیه بر روی عضله اعمال میکند و این مرحله با 2 ست 12 تایی کشش فعال عضله توسط خود بیمار تکمیل می شود.و درمرحله آخر بیمار، تمرین بالا آوردن شانه را به صورت 2 ست 15 تایی انجام می دهد. این تکنیک کلا در ۴ جلسه و هفته ای ۲ بار انجام می شود.
    #2
    N/A
    Treatment - Other
    Control group: There is no intervention.
    Intervention group: Dry needle technique is done using sterile needles and disposable Dong Bang with a length of 40 mm and a thickness of 0.25 mm.After the tight bundles are found in the upper trapezius muscle, the therapist inserts the needle at a 30-degree angle and inserts the needle out frequently and then again into another part of the trigger point, this procedure is repeated as long as no other local twitch response is felt. This technique is performed in 4 sessions and twice a week.
    گروه کنترل: هیچ مداخله ای دریافت نمی کند.
    گروه مداخله:تکنیک سوزن خشک با استفاده از سوزن های استریل و یکبار مصرف دانگ بنگ به طول 40 میلی متر و ضخامت 0.25 میلی متر انجام می شود.پس از لمس مناسب باندهای سفت در عضله ذوزنقه ای فوقانی ، درمانگر سوزن را با زاویه 30 درجه وارد نقاط ماشه ای کرده و سوزن را به طور مکرر مقداری بیرون کشیده و مجددا به قسمت دیگری از نقطه ماشه ای وارد میکند ، این کار تا زمانی تکرار می شود که هیچ پاسخ پرشی موضعی دیگری احساس نشود. این تکنیک کلا در ۴ جلسه و هفته ای ۲ بار انجام می شود.
    #3
    empty
    N/A
    empty
    Control group:There is no intervention.
    empty
    گروه کنترل: هیچ مداخله ای دریافت نمی کند.
  • Recruitment centers

    #1
    Name of recruitment center - English: The School of Rehabilitation Sciences, Shahid Beheshti University of Medical Sciences
    Name of recruitment center - Persian: دانشکده توانبخشی دانشگاه علوم پزشکی شهید بهشتی
    Full name of responsible person - English: DR. Farshad Okhovatian
    Full name of responsible person - Persian: دکتر فرشاد اخوتیان
    Street address - English: Damavand Ave., Imam Hossein Square (AS)., Tehran
    Street address - Persian: تهران - میدان امام حسین (ع)- خیابان دماوند
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1616913111
    Phone: +98 21 7756 1407
    Fax: +98 21 7759 1807
    Email: zeinab.ahmadpour1372@Gmail.com
    Web page address:
    Name of recruitment center - English: The School of Rehabilitation Sciences, Shahid Beheshti University of Medical Sciences
    Name of recruitment center - Persian: دانشکده توانبخشی دانشگاه علوم پزشکی شهید بهشتی
    Full name of responsible person - English: Farshad Okhovatian
    Full name of responsible person - Persian: فرشاد اخوتیان
    Street address - English: SBMU School of Rehabilitation Sciences., Damavand Ave., Imam Hossein Square (AS).,Tehran., Iran
    Street address - Persian: ایران، تهران، میدان امام حسین، خیابان دماوند، دانشکده توانبخشی شهید بهشتی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1616913111
    Phone: +98 21 7756 1407
    Fax: +98 21 7759 1807
    Email: Tavan2020@yahoo.com
    Web page address:
  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Alireza Akbarzadeh Baghban
    Full name of responsible person - Persian: دکتر علیرضا اکبرزاده باغبان
    Street address - English: Damavand Ave., Imam Hossein Square (AS).,Tehran
    Street address - Persian: میدان امام حسین(ع)-خیابان دماوند-دانشکده علوم توانبخشی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1616913111
    Phone: +98 21 7756 1407
    Fax: +98 21 7759 1807
    Email: zeinab.ahmadpour1372@Gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Afshin Zarghi
    Full name of responsible person - Persian: افشین زرقی
    Street address - English: 7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
    Street address - Persian: ایران، تهران، ولنجک، بلوار دانشجو، خیابان اعرابی، دانشگاه علوم پزشکی شهید بهشتی، ساختمان شماره 2، طبقه هفتم
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 19839-63113
    Phone: +98 21 2243 9770
    Fax: +98 21 2243 3455
    Email: zarghi@sbmu.ac.ir
    Web page address:

Protocol summary

Study aim
Comparison of the effects of two manual treatments separately in treating the active trigger points
Design
Clinical trial with control group, experimental-interventional, convenience sampling, random allocation.
Settings and conduct
The target community is selected from the students of the Rehabilitation School who have active trigger points in upper trapezius muscle. Sampling method is non-random and allocation of samples to groups will be random. Sampling will be done at the Biomechanics Laboratory of the Faculty of Rehabilitation.In this study data analyzer will be blind. The physiotherapist assesses the local pain intensity through (visual analog scale), active cervical contra lateral flexion using Goniometer and pressure pain threshold using algometer. Iranian version of neck disability index questionnaire will be used to determine the level of patient's ability. Variables will be assessed at the first session before and after the intervention and the fourth session and fourth week after the end of the treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Subjects between 18 and 40 years, Presence of active trigger points, Pain at least 30 mm in visual analog scale, Exclusion criteria: History of whiplash injury, History of head , neck , cervical spine or shoulder surgery, History of cervical radiculopathy, Diagnosed fibromyalgia and myopathy, History of cancer, Pregnancy, History of treatment in a past month, Contraindication of dry needling technique,
Intervention groups
Intervention group 1: Instrument assisted soft tissue mobilization technique , twice a week , For 2 weeks. Intervention group 2: Dry needling , twice a week , For 2 weeks. Control group: There is no intervention.
Main outcome variables
Pain intensity at the visual scale of pain, Pressure pain threshold, Active cervical contra lateral flexion, Neck disability index,

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180311039049N1
Registration date: 2018-11-03, 1397/08/12
Registration timing: prospective

Last update: 2018-12-24, 1397/10/03
Update count: 1
Registration date
2018-11-03, 1397/08/12
Registrant information
Name
Zeinab Ahmadpour emshi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3331 2736
Email address
z.ahmadpour@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of instrument assisted soft tissue mobilization technique (IASTM) with dry needling (DN) in improving pain pressure threshold (PPT) , active cervical contra lateral flexion (ACCLF) , pain intensity (PI) and neck disability index (NDI) in patients with active trigger points of the upper trapezius muscle
Public title
Comparison of instrument assisted soft tissue mobilization technique (IASTM) with dry needling (DN) on the active trigger points of the upper trapezius muscle
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Subjects between 18 and 40 years Presence of active trigger points in upper trapezius muscle Pain at least 30 mm in visual analog scale
Exclusion criteria:
History of whiplash injury History of head , neck , cervical spine or shoulder surgery History of cervical radiculopathy Diagnosed fibromyalgia and myopathy History of cancer Pregnancy Myofascial therapy within the past month Contraindication of dry needling technique
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a sample of 75 people, 25 cards for each intervention group and 25 cards for control group were considered and placed inside a sealed envelope that is non-transparent to draw then each patient takes one of the cards randomly and their group is identified and the generated sequence is recorded.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
19839-63113
Approval date
2017-08-13, 1396/05/22
Ethics committee reference number
IR.SBMU.RETECH.REC.1396.278

Health conditions studied

1

Description of health condition studied
Myofascial Trigger Points of the Upper Trapezius Muscle
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain intensity in the visual scale of pain
Timepoint
Measure the severity of pain in the first session before and after the intervention and the fourth session and fourth week after the end of treatment
Method of measurement
Visual analogue scale

Secondary outcomes

1

Description
Pain pressure threshold
Timepoint
Measurement at first session before and after intervention and the fourth session and fourth week after the end of treatment
Method of measurement
Digital algometer (Lutron FG-5020)

2

Description
Active cervical contra lateral flexion
Timepoint
Measurement at first session before and after intervention and the fourth session and fourth week after the end of treatment
Method of measurement
Goniometry

3

Description
Neck disability index
Timepoint
Measurement at first session before intervention and the fourth session and fourth week after the end of treatment
Method of measurement
Neck disability index- iranian version questionnaire

Intervention groups

1

Description
Intervention group: In this technique is first step to increase blood flow and muscle tissue temperature for 5 minutes, superficial heat will be used and then using the myo-release tool, muscle tissue will be massaged for 5 minutes. The soft tissue mobilization technique is carried out using the myo-release tool No. 1, made in Iran. The tool is made of stainless steel. Immediately after massage, the therapist applies 3 passive stretches for 30 seconds on the muscle and this phase is completed by the 2nd 12th active muscle stretches by the patient herself and in the final stage, the patient performs the shoulder elevation as 2 sets of 15. This technique is performed in 4 sessions and twice a week.
Category
Treatment - Other

2

Description
Intervention group: Dry needle technique is done using sterile needles and disposable Dong Bang with a length of 40 mm and a thickness of 0.25 mm.After the tight bundles are found in the upper trapezius muscle, the therapist inserts the needle at a 30-degree angle and inserts the needle out frequently and then again into another part of the trigger point, this procedure is repeated as long as no other local twitch response is felt. This technique is performed in 4 sessions and twice a week.
Category
Treatment - Other

3

Description
Control group:There is no intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
The School of Rehabilitation Sciences, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Farshad Okhovatian
Street address
SBMU School of Rehabilitation Sciences., Damavand Ave., Imam Hossein Square (AS).,Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1407
Fax
+98 21 7759 1807
Email
Tavan2020@yahoo.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9770
Fax
+98 21 2243 3455
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zeinab Ahmadpour Emshi
Position
MSC Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
SBMU School of Rehabilitation Sciences., Damavand Ave., Imam Hossein Square (AS).,Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1407
Fax
+98 21 7759 1807
Email
zeinab.ahmadpour1372@Gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
DR. Farshad Okhovatian
Position
Professor
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
SBMU School of Rehabilitation Sciences., Damavand Ave., Imam Hossein Square (AS).,Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1407
Fax
+98 21 7759 1807
Email
Farshadokhovatian1965@Gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zeinab Ahmadpour Emshi
Position
MSC Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
SBMU School of Rehabilitation Sciences.,Damavand Ave., Imam Hossein Square (AS).,Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1407
Fax
+98 21 7759 1807
Email
zeinab.ahmadpour1372@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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