Comparison of cervical trigger points’ management by Positional Release Therapy with routine medication in patients with tension type headache whoe has refered to Emam Reza & Shahid Faghihi clinics
Background:
The aim of this study was to compare the effectiveness of trigger points’ management by Positional Release Therapy and routine medical therapy in treatment of tension type headache.
Inclusion and exclusion criteria: patients with tension type headache and any trigger points in posterior cervical muscles will include to the study and patients with cervical disk herniation , patients who use opioid, anti anxiety and anti depressant drugs and pregnant patients will exclude from the study.
Sample size: In this study there will be 30 tension type headache patients with active trigger points in posterior cervical muscles who will choose among the patients that has refered to the Emam Reza and Shahid Faghihi clinics.
Intervention: 15 0f patients will enter to PRT group and 15 of them will enter to medication group. Headache frequency, intensity and duration and tablet count will record throughout the study by use of a daily headache diary. Sensitivity of trigger points will assess by numeric pain intensity (NPI) and by use of a digital force gauge (FG 5020).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204082708N4
Registration date:2012-04-25, 1391/02/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-04-25, 1391/02/06
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
2012-04-20, 1391/02/01
Expected recruitment end date
2012-09-20, 1391/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of cervical trigger points’ management by Positional Release Therapy with routine medication in patients with tension type headache whoe has refered to Emam Reza & Shahid Faghihi clinics
Public title
Treatment of tension type headache by positional release therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: tension type headache; trigger point in posterior cervical muscles
Exclusion criteria: cervical disk herniation; usage of opioid, anti anxiety and anti depressant drugs; pregnancy
Age
No age limit
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
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
Shiraz University of Medical Sciences
Street address
Zand street
City
Shiraz
Postal code
Approval date
2010-06-22, 1389/04/01
Ethics committee reference number
الف 5253-89
Health conditions studied
1
Description of health condition studied
Tension-Type headache
ICD-10 code
G44.2
ICD-10 code description
other headache syndromes
Primary outcomes
1
Description
headache intensity
Timepoint
before & after intervention, 2 weeks after last intervention
Method of measurement
daily headache diary
2
Description
headache duration
Timepoint
before & after intervention, 2 weeks after last intervention
Method of measurement
daily headache diary
3
Description
headache frequency
Timepoint
before & after intervention, 2 weeks after last intervention
Method of measurement
daily headache diary
4
Description
Tablet count
Timepoint
before & after intervention, 2 weeks after last intervention
Method of measurement
daily headache diary
Secondary outcomes
1
Description
pain tolerance in trigger point site
Timepoint
befor & after intervention, 2 weeks after last intervention
Method of measurement
pressure algometer
2
Description
pain intensity in trigger point site
Timepoint
befor & after intervention, 2 weeks after last intervention
Method of measurement
numeric pain index
Intervention groups
1
Description
positonal release therapy which is used 2 times per week for 5 treatment sessions. in this manner that patient is lied in a position in which the muscle is relaxed.
Category
Rehabilitation
2
Description
medication with Nortriptyline 25 mg once a day and meloxicam 15 mg twice a day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
rehabilitation school
Full name of responsible person
Marzieh Mohamadi
Street address
Abiverdi street
City
hiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shraz University of Medical Sciences
Full name of responsible person
Dr Gholamreza Hatam
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
Shraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr Ali Ghanbari
Position
Faculty of rehabilitation school
Other areas of specialty/work
Street address
Abiverdi street
City
Shiraz
Postal code
00987116271551
Phone
+98 71 1627 1551
Fax
Email
ghanbary@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Ali Ghanbari
Position
PhD of Physiotherapy
Other areas of specialty/work
Street address
Abiverdi street
City
Shiraz
Postal code
00987116271551
Phone
+98 71 1627 1551
Fax
Email
ghanbary@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Ali Ghanbari
Position
Faculty of rehabilitation school
Other areas of specialty/work
Street address
Abiverdi street
City
Shiraz
Postal code
00987116271551
Phone
+98 71 1627 1551
Fax
Email
ghanbary@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)