investigating the effect of dry needling of sternocleidomastoid on pain and disability in patient with cervicogenic headache
Design
Quasi-experimental Study, Before and After clinical trial
Settings and conduct
Twenty patients with a clinical diagnosis of Cervicogenic headache
and active trigger points in the sternocleidomastoid muscle are screen for eligibility criteria. Then the patient is asked to write headache frequency and headache duration (by hours) and headache intensity ( by visual analogue scale ) within 2 weeks and fill Persian version of headache disability questionnaire, after 2 weeks they receive trigger point dry needling of Sternocleidomastoid muscle, and they are requested to write headache frequency and headache duration and headache intensity within 2 weeks after intervention and fill Persian version of headache disability questionnaire again.
Participants/Inclusion and exclusion criteria
inclusion criteria: patient with unilateral headache that headache frequency of at least 1 per week over a period greater than 3 months.
exclusion criteria: dry needling contraindication, history of diagnosed primary headache
Intervention groups
one session dry needling of sternocleidomastoid muscle
Main outcome variables
pain and disability in patient with cervicogenic headache
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181109041599N1
Registration date:2019-05-04, 1398/02/14
Registration timing:registered_while_recruiting
Last update:2019-05-04, 1398/02/14
Update count:0
Registration date
2019-05-04, 1398/02/14
Registrant information
Name
Zahra Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3261 0840
Email address
zahra.mohammadi_73@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of one session dry needling of Sternocleidomastoid on pain and disability in patient with cervicogenic headache
Public title
Effect of dry needling in treatment of cervicogenic headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
unilateral pain that radiating to the frontotemporal region
pain aggravated by neck movement and/or sustained awkward head positions
moderate to severe non throbbing pain
presence of active triggger points in the sternocleidomastoid muscle
Having reading and writing skills
headache frequency of at least 1 per week over a period greater than 3 months
Exclusion criteria:
cervical radiculopathy
a history of neck trauma;
trigger point therapy or trigger point dry needling in the neck within the previous 6 months
subjects > 65 y due to vascular defects
evidence of cognitive deficits
dry needling contraindication : needle phobia, pregnancy, ...
previously had surgery in the neck or shoulder area
a history of diagnosed primary headache
the presence of any tumor in the region
systemic disease: diabetes, anemia and ...
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahanm university of medical sciences
Street address
departement of rehabilitationT, Isfahan University Of Medical sciences, University Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-01-23, 1397/11/03
Ethics committee reference number
IR.MUI.RESEARCH.REC.1397.374
Health conditions studied
1
Description of health condition studied
cervicogenic headache
ICD-10 code
G44
ICD-10 code description
Other headache syndromes
Primary outcomes
1
Description
headache intensity
Timepoint
2 weeks before and 2 weeks after intervention
Method of measurement
visual analogue scale
Secondary outcomes
1
Description
headache frequency
Timepoint
2 weeks before and 2 weeks after intervention
Method of measurement
days with headache
2
Description
headache duration
Timepoint
2 weeks before and 2 weeks after intervention
Method of measurement
hours with headache
3
Description
headache disability index
Timepoint
2 weeks before and 2 weeks after intervention
Method of measurement
Persian version of headache disability
Intervention groups
1
Description
Intervention group: one session trigger point dry needling of Sternocleidomastoid muscle which is performed 10 times in the muscle.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rehabilitation department
Full name of responsible person
Zahra Mohammadi
Street address
rehabilitation department, Isfahan university of medical science, university Blvd, Isfahan, Isfahan
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۱
Phone
+98 31 3792 5000
Email
tavanbakhshi@rehab.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooye javanmard
Street address
rehabilitation department, Isfahan university of medical science, university Blvd, Isfahan, Isfahan
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۱
Phone
+98 31 3792 5000
Email
tavanbakhshi@rehab.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Mohammadi
Position
student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
rehabilitation department, Isfahan university of medical science, university Blvd, Isfahan, Isfahan
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۱
Phone
+98 31 3792 5000
Email
zahra.mohammadi_73@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
zahramohammadi
Position
student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
rehabilitation department, Isfahan university of medical science, university Blvd, Isfahan, Isfahan
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۱
Phone
+98 31 3261 0840
Email
zahra.mohammadi_73@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Mohammadi
Position
student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
rehabilitation department, Isfahan university of medical science, university Blvd, Isfahan, Isfahan
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۱
Phone
+98 31 3261 0840
Email
zahra.mohammadi_73@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Individual Participant Data:
all collected deidentified IPD
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
using for Supplementary study
From where data/document is obtainable
e-mail address : Zahra.mohammadi_73@yahoo.com
What processes are involved for a request to access data/document
name, address, position, title of study and protocol of study