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Comparison of the effect of positional release therapy (PRT) on trigger points of cervical muscles and pharmacologic treatment with routine pharmacologic treatment in patients with migraine headache

Protocol summary

Summary
pupose of study: Comparison of the effect of positional release therapy (PRT) on trigger points of cervical muscles( upper trapezius,sternocloidomastoid,sub occipitals,multifidus,rotators and inter spinalis) and pharmacologic treatment with routine pharmacologic treatment in patients with migraine headache study design: randomized,single blind,single central,without a placebo group as the control group population study: patients with migraine headache according to IHS that refer to the Imam Reza clinic in Shiraz inclusion criteria: having migraine headache and at least one trigger point in upper trapezius,sternocloidomastoid,sub occipitals,multifidus,rotators and inter spinalis exclusion criteria: unusual migraine conditions-use of anti stress and anti depression drug,pregnancy sample size: 22 in each group study intervention: administration of PRT on cervical muscles of patients with migraine besides using routine drugs intervention duration: 6 months study outcomes: determination of intensity,duration,headache frequency,pain threshold & cervical range of motion in two weeks period before treatment,two weeks period after treatment start, one month period after treatment start,two months period after treatment start and six months period after treatment start in both groups

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201308292708N8
Registration date: 2014-04-22, 1393/02/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-04-22, 1393/02/02
Registrant information
Name
Ali Ghanbari
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 1551
Email address
ghanbary@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2014-02-20, 1392/12/01
Expected recruitment end date
2014-05-22, 1393/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of positional release therapy (PRT) on trigger points of cervical muscles and pharmacologic treatment with routine pharmacologic treatment in patients with migraine headache
Public title
Effect of cervical trigger points treatment in recovery of patients with migraine headache
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: having migraine headache and at least one trigger point in upper trapezius,sternocloidomastoid,sub occipitals,multifidus,rotators and inter spinalis-having periodical attacks in given temporal range that according to the patient affect on daily activity considerably.-cases of contriandications,non influense or over use of pharmacologic symptom therapy-using of pharmacologic treatment for acute headache over twice in a week exclusion criteria: unusual migraine conditions such as hemiplegic migraine,basilar migraine,migraine with long time aura and infarctions of migraine-use of anti stress and anti depression drug,smoking,myastenia gravis,complete obstruction of heart vessels-second grade obstruction of Atrioventricular valve-weak sinus syndrome-wolf parkinson white syndrme-sinosoidal brady cardia-acute and serius heart failure symptoms-chronic bronchitis-pulmunary amphism-chronic pulmunary obstruction disease-broncho spasm-liver failure-kidney failure-blood circulation failure-pregnancy-diabetic melitus-low blood sugar
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz university of medical science
Street address
Shiraz,Zand street,next to alzahra mosque
City
Shiraz
Postal code
Approval date
2017-02-15, 1395/11/27
Ethics committee reference number
CT-92-6834

Health conditions studied

1

Description of health condition studied
migraine headache
ICD-10 code
G43.0
ICD-10 code description
Migraine without aura [common migraine]

Primary outcomes

1

Description
headache intensity
Timepoint
before intervention,2 weeks after begining of intervention,1 month after begining of intervention,2 months after begining of intervention,6 months after begining of intervention
Method of measurement
questionare

2

Description
headache duration
Timepoint
before intervention,2 weeks after begining of intervention,1 month after begining of intervention,2 months after begining of intervention,6 months after begining of intervention
Method of measurement
questionare

3

Description
headache frequency
Timepoint
before intervention,2 weeks after begining of intervention,1 month after begining of intervention,2 months after begining of intervention,6 months after begining of intervention
Method of measurement
questionare

4

Description
Threshold of pain
Timepoint
before intervention,2 weeks after begining of intervention,1 month after begining of intervention,2 months after begining of intervention,6 months after begining of intervention
Method of measurement
pressure algometr device

5

Description
cervical range of motion
Timepoint
before intervention,2 weeks after begining of intervention,1 month after begining of intervention,2 months after begining of intervention,6 months after begining of intervention
Method of measurement
goniameter

Secondary outcomes

empty

Intervention groups

1

Description
intervention group:existing standard drug with positional release techniquedrug:Propranololdosage:60mg(20mg in form of 3 in day)in 1st month,80-120mg in 2nd month keeping on up to recovery.if the drug doesn't have effect,using drug would be cut.how to use:oral
Category
Treatment - Other

2

Description
control group: existing standard drug drug:Propranolol dosage:60mg(20mg in form of 3 in day)in 1st month,80-120mg in 2nd month keeping on up to recovery.if the drug doesn't have effect,using drug would be cut. how to use:oral
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza poly clinic
Full name of responsible person
dr.Peyman Petramfar
Street address
Shiraz,Namazi square
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz university of medical science
Full name of responsible person
saied Basir Hashemi
Street address
Shiraz,Zand Blvd,next to the alzahra mosque
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz university of medical science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz university of medical science,rehabilitation school
Full name of responsible person
Saghar Askarzadeh
Position
bachelor of physiotherapy,post graduate student
Other areas of specialty/work
Street address
Shiraz,Chamran Blvd.1st Abiverdi St,rehabilitation school
City
Shiraz
Postal code
Phone
+98 71 1625 8577
Fax
Email
askarzades42@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz university of medical science-rehabilitation school
Full name of responsible person
dr.Ali Ghanbary
Position
phd of physiotherapy
Other areas of specialty/work
Street address
Shiraz,Chamran Blvd,1st Abiverdi,rehabilitation school
City
Shiraz
Postal code
Phone
+98 62 71551
Fax
+98 71 1627 2495
Email
Ghanbary@sums.ac.ir
Web page address
rehab.sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz university of medical science-rehabilitation school
Full name of responsible person
Saghar Askarzadeh
Position
bachelor of physiotherapy-post graduate student
Other areas of specialty/work
Street address
Shiraz,Chamran Blvd,1st abiverdi,rehabilitation school
City
Shiraz
Postal code
Phone
+98 71 1625 8577
Fax
Email
askarzades42@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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