1. Home
  2. Approved trials
  3. » فارسی

A Sonographic Comparison of Effect of Dry Needling and Ischemic Compression on Active Trigger Point of the Sternocleidomastoid Muscle associated with Cervicogenic Headache

Protocol summary

Study aim
The aim of this study was to compare the effects of dry needling and ischemic compression on the clinical symptoms of cervicogenic headache originating from active trigger point in the sternocleidomastoid muscle and the biomechanical properties of, using ultrasonography imaging.
Design
The randomized clinical trial, with the aim of treatment, parallel group
Settings and conduct
After signing the informed consent, a form was given to the subjects to record headache parameters over the following two weeks. Subjects were assessed and then randomly distributed in three groups: control, ischemic compression, or dry needlig. After intervention sessions, subjects were evaluated again. All study process was done at Tarbiat Modares University.
Participants/Inclusion and exclusion criteria
Subjects were eligible with cervicogenic headache from trigger point in the sternocleidomastoid muscle. They were excluded if they had other types of headaches, had active trigger point in the other muscles of the neck and face, needle phobia, rheumatologic diseases, neck or shoulder surgery, or had any contraindications for interventions.
Intervention groups
Subjects were supine and the trigger point was compressed between the physiotherapist’s thumb and index finger in the ischemic compression group. In the dry needling group, the trigger point was grasped between the physiotherapist’s fingers and a needle was repeatedly inserted in the anterior-posterior direction.
Main outcome variables
Headache intensity, Headache duration, Headache frequency

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160621028567N1
Registration date: 2019-02-10, 1397/11/21
Registration timing: retrospective

Last update: 2019-02-10, 1397/11/21
Update count: 0
Registration date
2019-02-10, 1397/11/21
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 3559
Email address
m.jafarii@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
2018-09-01, 1397/06/10
Actual recruitment end date
2018-12-30, 1397/10/09
Trial completion date
2018-12-31, 1397/10/10
Scientific title
A Sonographic Comparison of Effect of Dry Needling and Ischemic Compression on Active Trigger Point of the Sternocleidomastoid Muscle associated with Cervicogenic Headache
Public title
The comparison of effect of dry needling and ischemic compression for cervicogenic headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Cervicogenic headache Active trigger point in the sternocleidomastoid muscle inducing headache
Exclusion criteria:
Other types of headache Active trigger points in the other muscles of neck and face Needle phobia Rheumatological diseases Neck and shoulder surgery Any contraindications for interventions
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Actual sample size reached: 29
Randomization (investigator's opinion)
Randomized
Randomization description
By simple randomization method, subjects were assigned to ischemic compression group(n=9), dry needling group (n=10), or control group (n=10). The sealed envelope was used for randomized allocation of subjects to the groups. In this way, subjects selected one of 29 similar sealed envelopes. Inside the envelopes were the name of one of the three groups that led to the assignment of the subjects to that group.
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
Committee of Ethics in Biomedical Research, Tarbiat Modares University
Street address
Jala Ale Ahmad, Nasr
City
Tehran
Province
Tehran
Postal code
1411713116
Approval date
2015-12-22, 1394/10/01
Ethics committee reference number
IR.TMU.REC.1394.163

Health conditions studied

1

Description of health condition studied
Cervicogenic headache
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Headache intensity
Timepoint
At the beginning of the study, two weeks after end of interventions
Method of measurement
Designed form for recording the clinical characteristics of headache

2

Description
Headache duration
Timepoint
At the beginning of the study, two weeks after end of interventions
Method of measurement
Designed form for recording the clinical characteristics of headache

3

Description
Headache frequency
Timepoint
At the beginning of the study, two weeks after end of interventions
Method of measurement
Designed form for recording the clinical characteristics of headache

Secondary outcomes

1

Description
Elastic modulus
Timepoint
At the beginning of the study, two weeks after end of intervention
Method of measurement
Ultrasound

2

Description
Trigger point area
Timepoint
At the beginning of the study, two weeks after end of intervention
Method of measurement
Ultrasound

3

Description
Pressure pain threshold
Timepoint
At the beginning of the study, two weeks after end of intervention
Method of measurement
Force gauge

Intervention groups

1

Description
Intervention group: ischemic compression. Subjects in the ischemic compression group were asked to lie in a supine position with their heads in contralateral rotation, the trigger point taut band was grasped between the clinician’s thumb and index finger and for 30-60 seconds maximal tolerable pressure was applied. This process was repeated three times with 30-second intervals. If the headache pattern was reproduced or the pain disappeared, ischemic compression was discontinued. The intervention was repeated 4 sessions within 8 days with one-day intervals between each treatment session.
Category
Rehabilitation

2

Description
Intervention group: dry needling. For the dry needling group, subjects were supine with neutral head, the trigger point was grasped between the clinician’s thumb, index, and middle fingers and a 0.25×40mm needle (DongBang Acuprime) was repeatedly inserted in the anterior-posterior direction as long as local twitch responses were extinct. The intervention was repeated 4 sessions within 8 days with one-day intervals between each treatment session.
Category
Rehabilitation

3

Description
Control group: no intervention. Subjects in the control group did not receive any treatments.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr Togha Headache Clinic
Full name of responsible person
Mansoureh Togha
Street address
Iranema Physician Building, 24th Ave, Ghaem Magham Ave, Haft-e Tir Square
City
Tehran
Province
Tehran
Postal code
1586984447
Phone
+98 21 8832 8351
Email
toghae@sina.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Mohammad Taghi Ahmadi
Street address
Jala Ale Ahmad, Nasr
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 2005
Email
mahmadi@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
Proportion provided by this source
50
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
Tarbiat Modares University
Full name of responsible person
Farid Bahrpeyma
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Jalal Ale Ahmad, Nasr
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3819
Email
bahrpeyf@modares.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Farid Bahrpeyma
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Jalal Ale Ahmad, Nasr
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3819
Email
bahrpeyf@modares.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Mehdi Jafari
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Jalal Ale Ahmad, Nasr
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3819
Fax
Email
m.jafarii@modares.ac.ir

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
part of data
When the data will become available and for how long
6 months after publication
To whom data/document is available
Researchers
Under which criteria data/document could be used
for treatment and research goals
From where data/document is obtainable
Dr Farid Bahrpeyma bahrpeyf@modares.ac.ir
What processes are involved for a request to access data/document
Confirmation of advisor professor
Comments
Loading...