History
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2 2019-12-20, 1398/09/29 116406
1 2018-02-11, 1396/11/22 36638
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  • Protocol summary

    The effects of treating myofascial trigger points of neck using the techniques of dry needling and soft tissue release on the clinical feature of patients with migraine headache
    The effect of trigger point therapy with dry needling and soft tissue release Techniques on clinical indexes of migraine headache patients
    n this study, 60 migraine patients with entry requirements who are referred to the Neurology Clinic of Shiraz Medical Sciences Hospital are selected. The participants are randomly divided into three groups of control, needle and soft tissue release.
    Sixty migraine patients who are referred to the Neurology Clinic of Shiraz Medical Sciences Hospital are selected. The participants are randomly divided into three groups of control, DN and STR.
    در این مطالعه 60 بیمار مبتلا به میگرن و دارای شرایط ورود به مطالعه که به کلینیک نورولوژی بیمارستان علوم پزشکی شیراز مراجعه می کنند انتخاب می شوند.شرکت کنندگان به صورت تصادفی به سه گروه کنترل ، سوزن خشک و آزادسازی بافت نرم تقسیم می شوند.
    در این مطالعه 60 بیمار میگرنی که به کلینیک نورولوژی بیمارستان علوم پزشکی شیراز مراجعه می کنند، انتخاب می شوند.شرکت کنندگان به صورت تصادفی به سه گروه کنترل، سوزن خشک و آزادسازی بافت نرم تقسیم می شوند.
    Migraine patients who come to the neurology clinic of Shiraz Medical Sciences Hospital are evaluated for the presence of trigger points in upper trapezius , suboccipital, and sternocleidomastoid muscles . The presence of trigger points is confirmed if there is a touch sensitive point in the muscles that causes the referral pain to be touched and also triggers a jump sign in the individual. In the presence of trigger points in suboccipital muscles, upper trapezius and sternocleidomastoid muscles, volunteers are included in the study and are assigned to three groups of control, dry needle and soft tissue release, based on simple block random allocation method. Blind study is done in the following cases: The two-blind study will be conducted in such a way that people are assigned to groups and patients are evaluated by people who are unaware of the patient grouping status. Treatment is provided by a specialist physiotherapist and evaluated by a collaborator.
    Migraine patients are evaluated for the presence of TRPs in UT, suboccipital, and SCM muscles. In the presence of TRPs in these muscles, subjects are assigned to three groups of control, DN and STR according to block randomization. The two-blind study will be conducted in such a way that people are assigned to groups and patients are evaluated by people who are unaware. Treatment is provided by a specialist physiotherapist and evaluated by a collaborator.
    بیماران میگرنی که به کلینیک نورولوژی بیمارستان علوم پزشکی شیراز مراجعه می کنند از نظر وجود نقاط ماشه ای در عضلات تراپزیوس فوقانی، ساب اکسیپیتال و استرنوکلوئیدوماستوئید ارزیابی می شوند. وجود نقاط ماشه ای در صورتی تأیید می شود که در عضلات مذکور، نقطه حساس به لمسی وجود داشته باشد که در اثر لمس درد ارجاعی ایجاد نماید و نیز باعث بروز علامت پرش در فرد شود . در صورت وجود نقاط ماشه ای در عضلات ساب آکسیپیتال ،تراپزیوس فوقانی و استرنوکلوئیدوماستوئید افراد داوطلب وارد مطالعه می شوند و بر مبنای روش تخصیص تصادفی ساده بلوک در سه گروه کنترل، سوزن خشک و آزادسازی بافت نرم قرار می گیرند. کور سازی مطالعه در موارد زیر صورت می گیرد: مطالعه بصورت دو سویه کور انجام خواهد شد، به این صورت که تخصیص افراد به گروه ها و ارزیابی بیماران توسط افرادی صورت می گیرد که نسبت به وضعیت گروه بندی بیماران، بی اطلاع می باشند. درمان توسط یک فیزیوتراپیست متخصص وارزیابی توسط همکار طرح صورت می پذیرد.
    بیماران میگرنی از نظر وجود نقاط ماشه ای در عضلات تراپزیوس فوقانی، ساب اکسیپیتال و استرنوکلوئیدوماستوئید ارزیابی می شوند. در صورت وجود نقاط ماشه ای در عضلات مذکور افراد بر مبنای روش تخصیص تصادفی ساده بلوک در سه گروه کنترل، سوزن خشک و آزادسازی بافت نرم قرار می گیرند. مطالعه بصورت دو سویه کور انجام خواهد شد، به این صورت که تخصیص افراد به گروه ها و ارزیابی بیماران توسط افراد بی اطلاع صورت می گیرد. درمان توسط یک فیزیوتراپیست متخصص وارزیابی توسط همکار طرح صورت می پذیرد.
    Inclusion:1. A neurologist selects the study subjects based on IHS criteria for diagnosis of migraine. 2.The patients with migraine are examined to find any active trigger points in UT, SCM, sub-occipital muscles 3.The flexion–rotation test Exclusion:1.a history of cervical disc herniation, unusual migraine 2.subjects who are pregnant or breastfeeding and those who having TRP therapy within the past month before the study. 3.The patients, who underwent DN, have no contraindication for needling such as local infection, pregnancy with threatened abortion, taking anticoagulants
    Inclusion: 1- Selection of patients according to International Headache Society criteria by neurologist . 2 - Active trigger points in the upper trapezius, sternocleidomastoid and suboccipital muscles. Exclusion: Cervical disc herniation, unusual migraine, pregnant subjects, and patients have contraindication for needling.
    شرایط ورود: 1.یک نورولوژیست بیماران بر اساس معیارهای انجمن بین المللی سردرد برای تشخیص میگرن انتخاب می کند 2.وجود نقاط ماشه اي فعال در عضلات تراپزیوس فوقانی ، استرنوکلوئیدوماستوئید و ساب آکسیپیتال 3.آزمون کلینیکی Flex Rot Test استفاده می شود شرایط خروج:1.بیمارانی با سابقه دیسک ناحیه گردن و میگرن غیرمعمول 2.بیماران حامله یا آنهایی که بچه شیر می دهند و آنهایی که در 1 ماه گذشته قبل از مطالعه درمان نقطه ماشه ای دریافت کردند 3.بیمارانی که سوزن خشک دریافت میکنند نباید کانتراایندیکشن مانند عفونت موضعی ، حاملگی با خطر سقط و کسانی که داروی ضدانعقاد می خورند، داشته باشند
    شرایط ورود: 1-انتخاب بیماران بر اساس معیارهای انجمن بین المللی سردرد توسط نورولوژیست 2- نقاط ماشه اي فعال در عضلات تراپزیوس فوقانی، استرنوکلوئیدوماستوئید و ساب آکسیپیتال. شرایط خروج: بیمارانی با دیسک ناحیه گردن و میگرن غیرمعمول، بیماران حامله و افرادی که کانتراایندیکشن سوزن داشته باشند.
    Dry needling group(DN): Dry needle technique is used on the trigger point (TRP) in the UT, SCM and suboccipital muscles. The needle is applied for three sessions at intervals of 48 hours between sessions. It should be noted that the needle cuff hits the trigger point of one of the following: creating a localized twitch response or creating a sense of distribution . Soft Tissue Release (STR) group: The treatment protocol for the STR included 5 steps. 1. Unilateral lateral stretch 2. Bilateral-lateral stretch 3. Long axis longitudinal stretch 4. Suboccipital muscle deep pressure 5. Separation origin and insertion Patients in the STR group receive each technique with repeated 5 times, hold 20 seconds, once a day for 6 days according in 2 weeks. Control group: Patients don’t receive any intervention in this group. Measurement of variables is done at the beginning of the entry to the study and similar to the two intervention groups, measurements of variables are performed in the second evaluation session. Of course, to consider ethical issues after the end of the plan, treatment is done in patients.
    Dry needling (DN): It is used on the trigger point (TRP) in the UT, SCM and suboccipital muscles. The needle is applied for three sessions. Soft Tissue Release (STR): It is included SCM muscle TRP therapy, suboccipital muscle inhibition, UT muscle TRP therapy, long axis longitudinal stretch, bilateral-lateral stretch. Patients receive each technique with repeated 5 times for 6 days. Control group: After the trigger points are determined, the therapist applied soft and superficial massage on the involved muscles.
    گروه سوزن خشک: تکنیک سوزن خشک روی نقطه ماشه ای در عضلات تراپزیوس فوقانی ، استرنوکلوئیدوماستوئید و ساب آکسیپیتال استفاده می شود. سوزن خشک به مدت سه جلسه به فاصله 48 ساعت بين جلسات انجام می شود . لازم به ذکر است که ملاک برخورد سوزن به نقطه ماشه اي يکي از موارد ذيل می باشد: ايجاد پاسخ توئيچ موضعي يا ايجاد حس انتشاري . گروه آزادسازی بافت نرم:پروتکل درمانی برای گروه آزادسازی بافت نرم شامل 5 فاز می باشد. 1- Unilatral lateral streach 2.Bilateral-lateral streach 3.Long axis longitudinal streach 4.Suboccipital muscle deep pressure 5-Separation of origin and insertion بیماران در گروه آزادسازی بافت نرم هر تکنیک 5 بار و هر بار 20 ثانیه یک بار در هفته تا 6 روز در 2 هفته دریافت می کنند. گروه کنترل: در این گروه بیماران هیچ گونه مداخله ای دریافت نمی کنند. در ابتدای ورود افراد به مطالعه، اندازه گیری متغیرها انجام می گیرد و مشابه دو گروه مداخله اندازه گیری متغیرها در دو نوبت دیگر ارزیابی مشابه گروه های مداخله صورت می گیرد. البته برای رعایت مسائل اخلاقی بعد از انتهای طرح ، درمان این بیماران انجام می گیرد.
    گروه سوزن خشک: این تکنیک روی نقطه ماشه ای عضلات تراپزیوس فوقانی، استرنوکلوئیدوماستوئید و ساب آکسیپیتال استفاده می شود. سوزن خشک به مدت سه جلسه انجام می شود. گروه آزادسازی بافت نرم:پروتکل درمانی شامل 5 فاز می باشد (درمان نقاط ماشه ای عضله استرنوکلوئیدوماستوئید، مهار بافت نرم ساب آکسیپیتال، درمان نقاط ماشه ای عضله تراپزیوس فوقانی،کشش محور طولی و کشش دوطرفه خارجی). بیماران هر تکنیک 5 بار تا 6 روز دریافت می کنند. گروه کنترل: بعد از اینکه نقاط ماشه ای تعیین شدند، درمانگر ماساژ نرم و سطحی روی عضلات درگیر اعمال کرد.
  • General information

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    68
    No
    Yes
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    20
    2017-09-23, 1396/07/01
    2018-04-02, 1397/01/13
    2018-01-21, 1396/11/01
    2018-07-21, 1397/04/30
    empty
    2018-04-07, 1397/01/18
    empty
    2018-09-10, 1397/06/19
    empty
    2018-09-10, 1397/06/19
    empty
    Since our study is prospective and unfortunately the starting date of the sample entry was incorrectly 2017 instead of 2018,we made the corrections.
    empty
    از آنجایی که مطالعه ما آینده نگر هست و متاسفانه تاریخ شروع نمونه ها به جای سال 97 به اشتباه 96 وارد شده بود، ما اصلاحات مدنظر انجام دادیم.
    empty
    20 subjects per group
    empty
    20 فرد در هر گروه
  • Intervention groups

    #1
    Control group: Control without intervention
    Control group: Placebo control
    گروه کنترل: کنترل بدون مداخله
    گروه کنترل: کنترل پلاسبو
  • Recruitment centers

    #1
    Name of recruitment center - English: Visual analog scale, Algometer, Ultrasonography, Goniometer,Neck disability index questionnaire and
    Name of recruitment center - Persian: کلینیک نورولوژی شیراز
    Full name of responsible person - English: Dr.Mansour Hedayati
    Full name of responsible person - Persian: دکتر منصور هدایتی
    Street address - English: Shiraz Shahid Chamran Avenue - Student Square - next to Amin Ali Pharmacy - Eram Building - Third Floor
    Street address - Persian: شیراز خیابان شهید چمران - میدان دانشجو - جنب داروخانه امین علی - ساختمان ارم - طبقه سوم
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 7185796184
    Phone: +98 71 3229 8382
    Fax:
    Email: tahere.rezaiyan@gmail.com
    Web page address:
    Name of recruitment center - English: Visual analog scale, Algometer, Ultrasonography, Goniometer,Neck disability index questionnaire and
    Name of recruitment center - Persian: کلینیک نورولوژی شیراز
    Full name of responsible person - English: Dr.Mansour Hedayati
    Full name of responsible person - Persian: دکتر منصور هدایتی
    Street address - English: Shiraz Shahid Chamran Avenue - Student Square - next to Amin Ali Pharmacy - Eram Building - Third Floor
    Street address - Persian: شیراز خیابان شهید چمران - میدان دانشجو - جنب داروخانه امین علی - ساختمان ارم - طبقه سوم
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 7185796184
    Phone: +98 71 3229 8382
    Fax:
    Email: tahere.rezaiyan@gmail.com
    Web page address:

Protocol summary

Study aim
The effect of trigger point therapy with dry needling and soft tissue release Techniques on clinical indexes of migraine headache patients
Design
Sixty migraine patients who are referred to the Neurology Clinic of Shiraz Medical Sciences Hospital are selected. The participants are randomly divided into three groups of control, DN and STR.
Settings and conduct
Migraine patients are evaluated for the presence of TRPs in UT, suboccipital, and SCM muscles. In the presence of TRPs in these muscles, subjects are assigned to three groups of control, DN and STR according to block randomization. The two-blind study will be conducted in such a way that people are assigned to groups and patients are evaluated by people who are unaware. Treatment is provided by a specialist physiotherapist and evaluated by a collaborator.
Participants/Inclusion and exclusion criteria
Inclusion: 1- Selection of patients according to International Headache Society criteria by neurologist . 2 - Active trigger points in the upper trapezius, sternocleidomastoid and suboccipital muscles. Exclusion: Cervical disc herniation, unusual migraine, pregnant subjects, and patients have contraindication for needling.
Intervention groups
Dry needling (DN): It is used on the trigger point (TRP) in the UT, SCM and suboccipital muscles. The needle is applied for three sessions. Soft Tissue Release (STR): It is included SCM muscle TRP therapy, suboccipital muscle inhibition, UT muscle TRP therapy, long axis longitudinal stretch, bilateral-lateral stretch. Patients receive each technique with repeated 5 times for 6 days. Control group: After the trigger points are determined, the therapist applied soft and superficial massage on the involved muscles.
Main outcome variables
1. Pain intensity 2. Pressure pain threshold 3.Muscle thickness 4.Disability Index 5.Cervical range of motions measurement 6-Headache parameters

General information

Reason for update
Since our study is prospective and unfortunately the starting date of the sample entry was incorrectly 2017 instead of 2018,we made the corrections.
Acronym
DNSTR
IRCT registration information
IRCT registration number: IRCT20171219037956N1
Registration date: 2018-02-11, 1396/11/22
Registration timing: prospective

Last update: 2020-01-02, 1398/10/12
Update count: 1
Registration date
2018-02-11, 1396/11/22
Registrant information
Name
tahere rezaeian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0039
Email address
ta.rezaeian@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-02, 1397/01/13
Expected recruitment end date
2018-07-21, 1397/04/30
Actual recruitment start date
2018-04-07, 1397/01/18
Actual recruitment end date
2018-09-10, 1397/06/19
Trial completion date
2018-09-10, 1397/06/19
Scientific title
The effects of treating myofascial trigger points of neck using the techniques of dry needling and soft tissue release on the clinical feature of patients with migraine headache
Public title
Effects of dry needling and soft tissue release in treatment of migraine patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. A neurologist selected the study subjects based on IHS criteria for diagnosis of migraine. 2. The patients in this study were between the ages of 25 and 55 years old The patients with migraine were examined to find any active trigger points in UT, SCM, sub-occipital muscles . The presence of active trigger points was confirmed if “1- There was an area of focal muscle tenderness that was activated by palpation and that, when activated, referred pain replicating the patient’s headache complaint. 2- There was a jump sign that was the characteristic behavioral response to pressure on a trigger point” . One diagnostic test in particular, the flexion–rotation test, is said to determine C1-2 dysfunction .Patient was supine position. With the subject relaxed and the cervical spine is fully flexed with the occiput resting against the examiners. The head is then rotated to the left and the right. If firm resistance is percieved, pain provoked and range is limited before the expected end range .The normal range is reported at 44-45 degrees, therefore, the test is positive when the range of motion is more than 10 degrees from the normal range.Studies have shown that migraine has a small effect on the range of motion during this test, but this test shows the presence or absence of cervicogenic headache and this test can use for Differential Diagnosis between migraine headache and cervicogenic headache.The positive test indicates a cervicogenic headache
Exclusion criteria:
history of cervical disc herniation, unusual migraine, heart failure, pulmonary failure, kidney failure, liver failure, circulation failure, diabetes mellitus patients who were using opioid prophylaxis, anti -depressant, anti-anxiety drugs subjects who were pregnant or breastfeeding and Those who having trigger point therapy within the past month before the study The patients, who underwent DN, had no contraindication for needling such as local infection, pregnancy with threatened abortion, taking anticoagulants
Age
From 25 years old to 55 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 60
More than 1 sample in each individual
Number of samples in each individual: 20
20 subjects per group
Actual sample size reached: 68
More than 1 sample in each individual
Actual sample size in each individual: 20
20 subjects per group
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Double-blind study will be done,in this way, the allocation of people to the groups and the assessment of patients are done by people who are unaware of the status of the grouping of patients.Treatment is provided by a specialist physiotherapist and evaluated by a collaborator.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of the University of Social Welfare and Rehabilitation Sciences
Street address
Koodakyar St., Daneshjoo Blvd,Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985713834
Approval date
2016-06-19, 1395/03/30
Ethics committee reference number
IR.USWR.REC.1395.192

Health conditions studied

1

Description of health condition studied
Migraine patients
ICD-10 code
I67.8
ICD-10 code description
Other specified cerebrovascular diseases

Primary outcomes

1

Description
1-Headache frequency
Timepoint
Before,After and 1month follow up
Method of measurement
Daily note form

2

Description
2-Headache intensity
Timepoint
Before,After and 1month follow up
Method of measurement
Daily note form

3

Description
3-Headache duration
Timepoint
Before,After and 1month follow up
Method of measurement
Daily note form

4

Description
Number of drug consumption
Timepoint
Before,After and 1month follow up
Method of measurement
Daily note form

Secondary outcomes

1

Description
1.Pressure pain threshold
Timepoint
Before, After and 1month follow up
Method of measurement
Algometer

2

Description
2-Muscle thickness
Timepoint
Before, After and 1month follow up
Method of measurement
Ultrasonography

3

Description
3-Range of motion
Timepoint
Before, After and 1month follow up
Method of measurement
Goniometer

4

Description
4-Neck disability index
Timepoint
Before, After and 1month follow up
Method of measurement
Neck disability index questionnaire

5

Description
5-Head disability index
Timepoint
Before, After and 1month follow up
Method of measurement
Head disability index questionnaire

6

Description
6-Pain intensity
Timepoint
Before, After and 1month follow up
Method of measurement
Visual analog scale

Intervention groups

1

Description
Intervention group: Dry needling
Category
Rehabilitation

2

Description
Intervention group: Soft tissue release
Category
Rehabilitation

3

Description
Control group: Placebo control
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Visual analog scale, Algometer, Ultrasonography, Goniometer,Neck disability index questionnaire and
Full name of responsible person
Dr.Mansour Hedayati
Street address
Shiraz Shahid Chamran Avenue - Student Square - next to Amin Ali Pharmacy - Eram Building - Third Floor
City
Shiraz
Province
Fars
Postal code
7185796184
Phone
+98 71 3229 8382
Email
tahere.rezaiyan@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Hamidreza Khanakeh
Street address
kodakyar Ave., daneshjo Blvd.,Evin.,Tehran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0050
Fax
Email
rd@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation 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
University of social welfare and rehabilitation sciences
Full name of responsible person
Tahere Rezaeian
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
kodakyar Ave., daneshjo Blvd.,Evin,Tehran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0039
Email
tahere.rezaiyan@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Tahere Rezaeian
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
kodakyar Ave., daneshjo Blvd.,Evin,Tehran
City
Tehran
Province
Tehran
Postal code
7185796184
Phone
+98 21 2218 0039
Email
tahere.rezaiyan@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Tahere Rezaeian
Position
Tehran
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Koodakyar St., Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
7185796184
Phone
+98 21 2218 0039
Email
tahere.rezaiyan@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
Some of the data, such as information about the consequences, can be shared
When the data will become available and for how long
Starting the access period: 6 months after publition the results
To whom data/document is available
Researchers working in academic and academic institutions
Under which criteria data/document could be used
Only statistical analyzes can be used to find treatment for improvement of patients
From where data/document is obtainable
Applicants can be guided by email authors
What processes are involved for a request to access data/document
First, they will email the authors of the study and we Will be answered within a week
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