Objective: In this study we try to determine the effectiveness of trigger point management by Positional Release Technique on central sensitization in tension type headache patients.
Design: This study is a randomized clinical trial by simple sampling method. Subjects are patients with tension type headache which will be randomly divide to two treatment and control groups. Patients are blind about study groups.
Setting and Conduct: The pressure pain threshold and concentration of brain metabolites will be recorded by Algometer and MRS respectively before and after treatment.
Participants: 26 patients with tension type headache and any trigger points in cervical muscles will enter to the study.
Intervention: Treatment group receive Positional Release therapy (PRT) on the trigger points of cervical muscles. Control group receive routine drugs.
Main outcome measures: Pressure pain threshold and brain metabolite concentration.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016071726674N2
Registration date:2016-08-23, 1395/06/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-08-23, 1395/06/02
Registrant information
Name
Marzieh Mohamadi
Name of organization / entity
Shiraz University of Medical Sciences, School of Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 1551
Email address
mohamadm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2016-07-31, 1395/05/10
Expected recruitment end date
2017-08-01, 1396/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cervical trigger point management by Positional Release Therapy on the central sensitization in patients with tension type headache
Public title
The effect of cervical trigger point management on tension type headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Existence more than 3 months of headache; Existence of any trigger points in cervical muscles.
exclusion criteria: other types of headaches; cervical disk herniation; neurological disorders; rheumatoid disorders; history of whiplash injury or head trauma; useage of anti-depressant and anti-anxiety drugs; complain from knee or leg pain.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
26
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization is done by blocked randomization methode
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Zand Street
City
Shiraz
Postal code
Approval date
2016-06-06, 1395/03/17
Ethics committee reference number
IR.SUMS.REC.1395.47
Health conditions studied
1
Description of health condition studied
tension type headache
ICD-10 code
G44.2
ICD-10 code description
Tension-type headache
Primary outcomes
1
Description
pressure pain threshold
Timepoint
5 weeks
Method of measurement
Algometer instrument
2
Description
consentration of Total Choline (tCho)
Timepoint
5 weeks
Method of measurement
MRS instrument
3
Description
concentration of N-Acetyl-Aspartate (NAA)
Timepoint
5 weeks
Method of measurement
MRS instrument
4
Description
consentration of Creatin (Cr)
Timepoint
5 weeks
Method of measurement
MRS instrument
5
Description
concentration of Myo-Inositol (MI)
Timepoint
5 weeks
Method of measurement
MRS instrument
6
Description
concentration of Glx
Timepoint
5 weeks
Method of measurement
MRS instrument
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Routine treatment
Category
Treatment - Drugs
2
Description
Intervention group: Positional release Technique
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza (A) clinic
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Doctor Seyed-Basir Hashemi
Street address
Zand Street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shiraz University of Medical Sciences
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
School of Rehabilitation Sciences, Shiraz University of Medical Sciences
Full name of responsible person
Marzieh Mohamadi
Position
Student
Other areas of specialty/work
Street address
Abiverdi 1 Street
City
Shiraz
Postal code
Phone
+98 71 3627 1551
Fax
Email
mohamadm@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Rehabilitation sciences, Shiraz University of Medical sciences
Full name of responsible person
Doctor Zahra Rojhani Shirazi
Position
Associated Professor
Other areas of specialty/work
Street address
Abiverdi 1 Street
City
Shiraz
Postal code
Phone
+98 71 3627 1551
Fax
Email
rojhaniz@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences, School of Rehabilitation Sciences
Full name of responsible person
Marzieh Mohamadi
Position
Student
Other areas of specialty/work
Street address
Abiverdi 1 Street
City
Shiraz
Postal code
Phone
+98 71 3627 1551
Fax
Email
mohamadm@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)