Background: Headache is one of the most common neurological condition that has affect on a lot of people. Tension type headache (TTH) is one of the most common type of headache in society. Tension type headache involves myofascial and CNS factors. Myofascial activity can be a source of TTH due to trigger points. Sometime in drug therapy, the patient's body does not respond appropriately. For this reason, non-pharmacological treatments should always be considered. One of the treatments for TTH patients is manual therapy.
Materials and Methods: This study is a clinical trial. The sample size was 12 people in each group. Subjects with tension type headache that do not respond to the drug will be selected. Inclusion criteria: A headache that lasts from 30 minutes to 7 days. exclusion criteria: Surgical surgery; Neck disc hernia
After filling the consent forms, the samples are subdivided into two groups by random method(treatment group and control group). The treatment group receives a series of manual therapy including massage, release of myofascia , release trigger points with friction massage and cervical mobilization . The severity of pain, the number of pills, cervical range of motion and NDI questionnaire will be evaluated in these individuals.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017082924149N36
Registration date:2017-09-26, 1396/07/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-26, 1396/07/04
Registrant information
Name
Fahimeh Kamali
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 1551
Email address
kamalif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Science
Expected recruitment start date
2017-09-16, 1396/06/25
Expected recruitment end date
2017-10-27, 1396/08/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of manual therapies on severity and frequency of pain in patients with tension headache that does not respond to the drug
Public title
The effect of manual therapy on patients with tension type headache that do not respond to the drug
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Headache that lasts from several minutes to several hours; According to the IHS criteria . Headache that has at least two characteristics:No pulsating mode; Its severity is mild to moderate; Do not exacerbate daily activities such as walking and climbing the stairs; Not having nausea and vomiting and photophobia and phonophobia during the attack.
Exclusion criteria: Cervical surgery; Cervical disc hernia; Pregnancy; Breastfeeding; Migraine; Severe cervical trauma; Cervical Malignancy; Rheumatism; Fibromyalgia; Cardiovascular disease; Physiotherapy and massage in the last 6 months; Temporomandibular joint disorder.
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
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
Ethic committee of Shiraz University of Medical Science
Street address
Zand street, forward Flestin street, Central building of Shiraz University of Medical Science
City
Shiraz
Postal code
7134814336
Approval date
2017-07-18, 1396/04/27
Ethics committee reference number
IR.SUMS.REC.1396.64
Health conditions studied
1
Description of health condition studied
Tension type headache
ICD-10 code
G44.2
ICD-10 code description
Chronic tension-type headache, Episodic tension headache, Tension headache NOS
Primary outcomes
1
Description
pain intensity
Timepoint
before treatment, after treatment, 1 week after treatment
Method of measurement
Numerical rating scale pain
2
Description
Pain frequency
Timepoint
before treatment, after treatment, 1 week after treatment
Method of measurement
The number of days that patients have headache in one week
3
Description
Consumed pills
Timepoint
before treatment, after treatment, 1 week after treatment
Method of measurement
The number of pills in one week
Secondary outcomes
1
Description
Neck Disability Index
Timepoint
before treatment , after treatment , one week after treatment
Method of measurement
Score questionnaire
2
Description
Cervical range of motion
Timepoint
before treatment , after treatment , one week after treatment
Method of measurement
Goniameter
Intervention groups
1
Description
The control group does not receive manual therapy
Category
N/A
2
Description
In this study, the treatment group received a manual therapy package, including the release of the neck and shoulders fascia , cervical moblization, the release of the trigger points of the upper trapezius , sub occipital and sternocloidomastoid muscles with friction. The case group receives three sessions of treatment.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Clinic
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Science , Faculty of Rehabilitation Sciences
Full name of responsible person
Fahimeh kamali-Sarvestani
Street address
Abiverdi St, Chmaran Ave, Shiraz, Iran
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 , Faculty of Rehabilitation 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 Science
Full name of responsible person
Fahimeh Kamali-Sarvestani
Position
employee of a Shiraz University of Medical Sciences
Other areas of specialty/work
Street address
Abiverdi St, Chmaran Ave, Shiraz, Iran
City
Shiraz
Postal code
7194733669
Phone
+98 71 3626 1081
Fax
Email
negarazhdari12@gmail.com
Web page address
http://rehab.sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Fahimeh Kamali-Sarvestani
Position
PHD
Other areas of specialty/work
Street address
Abiverdi St, Chmaran Ave, Shiraz, Iran
City
Shiraz
Postal code
7194733669
Phone
+98 71 3626 1081
Fax
Email
kamalif@sums.ac.ir
Web page address
http://rehab.sums.ac,ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Negar Azhdari
Position
Master's degree in Physiotherapy
Other areas of specialty/work
Street address
Abiverdi St, Chmaran Ave, Shiraz, Iran
City
Shiraz
Postal code
7194733669
Phone
+98 71 3626 1081
Fax
Email
negarazhdari12@gmail.com
Web page address
http://rehab.sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)