Objectives: The aim of the present study is to evaluate the effect of low level laser therapy (LLLT) on trigger points (TPs) of upper Trapezius, Sternocleidomastoid and Temporal muscles. Design: This is a randomized clinical trial. Setting and conduct: The study population are the patients with cervicogenic headache (CGH). Thirty Patients based on inclusion criteria will be participated in the present study. Patients will be randomly divided in 3 groups: a control group as group 1 (which have their prescribe medication), a sham group ("laser off" on the TPs) as group 2 and a treatment group ("laser on" for the TPs) as group 3. Major Inclusion criteria: patients between 18 to 40 years old; existence of minimum one trigger point in upper trapezius muscle with or without existence of trigger points in other 2 muscles of the present study; more than 10 degree limitation in cervical flexion or rotation to each side. Major Exclusion criteria: history of fracture in cervical region; pregnancy; history of whiplash injury and neck surgery; any conservative treatment during the last 3 months before starting the present study. Intervention: a low power laser with intensity of 11 joules and frequency of 3 Kilohertz will be used for laser therapy. There will be 6 sessions’ treatments within 2 weeks for groups 2 and 3. The variables will be measured two weeks before the first session and two weeks after the last session (follow up phase). Main outcome measures (variables): Head Disability Index (HDI), intensity and duration of headache and also active cervical range of motion.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017030118754N5
Registration date:2017-04-22, 1396/02/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-22, 1396/02/02
Registrant information
Name
Javad Sarrafzadeh
Name of organization / entity
Iran University of Medical Sciences, School of Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
00982122228051-00982122227124
Email address
sarrafzadeh.j@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences, Vice chancellor for research
Expected recruitment start date
2017-04-04, 1396/01/15
Expected recruitment end date
2018-10-07, 1397/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of low level laser therapy on myofacial trigger points of cervical muscles in patients with cervicogenic headache.
Public title
The effect of laser therapy on pain of patients with cervicogenic headache.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with cervicogenic headache (CGH) and between 18 to 40 years old; existence of minimum one trigger point in upper trapezius muscle with or without existence of trigger points in other 2 muscles of the present study; more than 10 degree limitation in cervical flexion and/or rotation to each side. Exclusion criteria: any congenital deformity; long time usage of corticosteroids or anti-inflammatory and anti-analgesic drugs; history of fracture in cervical region; herniated disc; rheumatoid arthritis; pregnancy; history of whiplash injury and neck surgery; any conservative treatment during the last 3 months before starting the present study.
Age
From 18 years old to 55 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not 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
Ethics committee of Iran University of Medical Sciences
Street address
5th floor, Iran University of Medical Sciences, Hemmat highway
City
Tehran
Postal code
15459-13487
Approval date
2016-12-10, 1395/09/20
Ethics committee reference number
IR.IUMS.REC 1395.95-03-32-28292
Health conditions studied
1
Description of health condition studied
Cevicogenic headache
ICD-10 code
G44
ICD-10 code description
Other headache syndromes
Primary outcomes
1
Description
Intensity of headache
Timepoint
Two weeks Before starting the treatment sessions, before the first treatment session, at the end of treatment session and two weeks after the last treatment session
Method of measurement
Visual analog scale (VAS)
2
Description
Frequency of headache
Timepoint
Two weeks Before starting the treatment sessions, before the first treatment session, at the end of treatment session and two weeks after the last treatment session
Method of measurement
Number of headache during one week
3
Description
Active cervical flexion range of motion
Timepoint
Two weeks Before starting the treatment sessions, before the first treatment session, at the end of treatment session and two weeks after the last treatment session
Method of measurement
CROM device
4
Description
Active cervical rotation range of motion to left and right
Timepoint
Two weeks Before starting the treatment sessions, before the first treatment session, at the end of treatment session and two weeks after the last treatment session
Method of measurement
CROM device (degree)
5
Description
Pain threshold
Timepoint
Two weeks Before starting the treatment sessions, before the first treatment session, at the end of treatment session and two weeks after the last treatment session
Method of measurement
By an algometer (algometry)
6
Description
Quality of life
Timepoint
Two weeks Before starting the treatment sessions, before the first treatment session, at the end of treatment session and two weeks after the last treatment session
Method of measurement
Headache diability index (HDI) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Group 3 or intervention group: low level laser radiation with wavelength of 810 nm, in pulsed mode, with 11 joules intensity on trigger points of the 3 muscles of the present study.
Category
Rehabilitation
2
Description
Group 2 or Sham group: laser probe is placed on the trigger points of the 3 muscles of the present study but the laser device is off and patients do not know that. Patients use their prescription drugs.
Category
Rehabilitation
3
Description
Group 1 or control group: there is no intervention and patients just use their prescription drugs.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Physical therapy clinic of rehabilitation school of Iran university of medical sciences
Full name of responsible person
Javad Sarrafzadeh
Street address
Physiotherapy Clinic of School of Rehabilitation Sciences, Madadkaran street., Shahnazari street, Mirdamad street.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences, Vice chancellor for research
Full name of responsible person
Seyed Ali Javad Moosavi, Vice chancellor for research
Street address
5th Floor, Iran University of Medical Sciences, Hemmat highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences, Vice chancellor for research
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, Iran University of Medical Sciences
Full name of responsible person
Javad Sarrafzadeh
Position
PT, PhD in Physiotherapy, Associated Professor
Other areas of specialty/work
Street address
Physiotherapy department, School of Rehabilitation Sciences, Madadkaran street., Shahnazari street, Mirdamad street.
City
Tehran
Postal code
15459-13487
Phone
+98 21 2222 8051
Fax
+98 21 2222 0946
Email
sarrafzadeh.j@iums.ac.ir
Web page address
http://rehab.iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Rehabilitation Sciences, Iran University of Medical Sciences.
Full name of responsible person
Javad Sarrafzadeh
Position
PT, PhD in Physiotherapy, Associated Professor
Other areas of specialty/work
Street address
Physiotherapy department, School of Rehabilitation Sciences, Madadkaran street., Shahnazari street, Mirdamad street.
City
Tehran
Postal code
15459-13487
Phone
+98 21 2222 8051
Fax
+98 21 2222 0946
Email
sarrafzadeh.j@iums.ac.ir j.sarrafzadeh@gmail.com
Web page address
http://rehab.iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Department of Physical therapy, School of Rehabilitation Sciences, Iran University of Medical Scienc
Full name of responsible person
Javad Sarrafzadeh
Position
PT, PhD in Physiotherapy, Associated Professor
Other areas of specialty/work
Street address
Physiotherapy department, School of Rehabilitation Sciences, Madadkaran street., Shahnazari street, Mirdamad street.
City
Tehran
Postal code
15459-13487
Phone
+98 21 2222 8051
Fax
+98 21 2222 0946
Email
sarrafzadeh.j@iums.ac.ir j.sarrafzadeh@gmail.com
Web page address
http://rehab.iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)