Protocol summary

Study aim
Comparison of effect of dry needling, physiotherapy, and sham dry needling in cervicogenic headache
Design
A triple blind randomized clinical trial consisting of three routine physiotherapy groups and a routine physiotherapy with dry needles and a routine physiotherapy with a placebo needle.
Settings and conduct
Patients in the routine physical therapy group for fifteen sessions, three times a week, will undergo physiotherapy including electrical stimulation, surface heat, neck ultrasound and neck stabilization exercises. In dry needle group, in addition to the above items, dry needle will be performed according to the Dommerholt method for 4 sessions and the second, fifth, eighth and twelfth sessions will be performed at the active trigger points of the upper trapezius muscles, cervical erector spine muscles and sternocleidomastoid. In the placebo group, the needle is very superficial and at a point away from active trigger points during 4 sessions in the muscles, so that we can differentiate the effects of placebo needle dry from its actual effects.The assessments will be done before the treatment immediately after treatment, one month later, three and six months later.
Participants/Inclusion and exclusion criteria
Unilateral headache Starting in the neck Pain aggravated by neck movement Restricted cervical range of motion Joint tenderness in the joints of the upper cervical spine Active trigger point in neck muscles
Intervention groups
The cervicogenic headache are randomly divided into three groups. The first group routine physiotherapy, the second group routine physiotherapy and dry needle, the third group routine physiotherapy and placebo needle
Main outcome variables
The severity and frequency of headaches, Neck range of motion, pressure Pain threshold and tenderness at the trigger point of the muscles, Function of deep neck flexor muscles, neck proprioception

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180721040539N1
Registration date: 2018-09-24, 1397/07/02
Registration timing: registered_while_recruiting

Last update: 2018-09-24, 1397/07/02
Update count: 0
Registration date
2018-09-24, 1397/07/02
Registrant information
Name
Roghayeh Mousavi-khatir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 2832
Email address
r-mousavi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of dry needling, physiotherapy, and sham dry needling in cervicogenic headache- A randomized controlled clinical trial
Public title
The effect of dry needling in cervicogenic headache- A randomized controlled clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Unilateral pain Starting in the neck and radiating to the frontotemporal region Pain aggravated by neck movement Restricted cervical range of motion Joint tenderness in at least one of the joints of the upper cervical spine (C1-C3) Headache frequency of at least 1 per week over a period greater than 3 months Active trigger point in the suboccipital and upper trapezius and sternoclidomastoid muscles
Exclusion criteria:
Cervical radiculopathy A history of spinal or shoulder trauma or spinal surgery History of physical therapy intervention in the neck and shoulder region within the previous 6 months Diagnosed primary headache Needle phobia
Age
From 19 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
At first, a physiotherapist with ten years of experience perform patient’s physical examination. If they meet the conditions for entry into the study, and don’t have exclusion criteria, a randomization into three groups (control and DN group, sham DN group) was performed by packed envelopes via blind independent researcher to aim of allocation concealment.
Blinding (investigator's opinion)
Triple blinded
Blinding description
In sham dry needling group, the patient will not be aware of the fact that he/she does not receive the actual dry needling. The assessor and therapist will two different individuals and assessor blind to intervention. Also , statistical analysis will be done by a person who is blind to grouping
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Babol University of Medical Sciences
Street address
University of Medical Sciences , Ganjafrooz Street , Babol , Mazandaran ,Iran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Approval date
2018-06-10, 1397/03/20
Ethics committee reference number
IR.MUBABOL.HRI.REC.1397.071

Health conditions studied

1

Description of health condition studied
cervicogenic headache patients
ICD-10 code
G44.0
ICD-10 code description
Other headache syndromes

Primary outcomes

1

Description
intensity of the headache
Timepoint
Before treatment, immediately after treatment, one , three and six month later
Method of measurement
questionnaire

2

Description
headache frequency
Timepoint
Before treatment, immediately after treatment, one , three and six month later
Method of measurement
questionnaire

3

Description
Neck range of motion
Timepoint
Before treatment, immediately after treatment, one , three and six month later
Method of measurement
Goniometry

4

Description
Function of deep neck flexor muscles
Timepoint
Before treatment, immediately after treatment, one , three and six month later
Method of measurement
pressure biofeedback

5

Description
Pressure pain threshold and tenderness at the trigger point of the muscles
Timepoint
Before treatment, immediately after treatment, one , three and six month later
Method of measurement
Algometer

6

Description
Neck proprioception
Timepoint
Before treatment, immediately after treatment, one , three and six month later
Method of measurement
laser pointer and software

Secondary outcomes

1

Description
Quality of life
Timepoint
Before treatment, Immediately after treatment, One month later, Three months and Six month later
Method of measurement
Quality of life questionnaire

2

Description
Functional rating index
Timepoint
Before treatment, Immediately after treatment, One month later, Three months and Six month later
Method of measurement
Functional rating index-questionnaire

Intervention groups

1

Description
Intervention group 1: Routine physiotherapy and dry needle
Category
Rehabilitation

2

Description
Intervention group2: Routine physiotherapy and placebo needle
Category
Rehabilitation

3

Description
Intervention group 3: Routine physiotherapy
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Rouhani Educational and Therapeutic Center
Full name of responsible person
Roghayeh Mousavi-Khatir
Street address
Ayatollah Rouhani Educational and Therapeutic Center, Ganjafrooz Street, Babol , Mazanda, Iranran
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Phone
+98 11 3219 4641
Fax
+98 11 3219 0181
Email
r-mousavi@mubabol.ac.ir
Web page address
http://rohani.mubabol.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Reza Ghadimi
Street address
University of Medical Sciences , Ganjafrooz Street , Babol , Mazandaran ,Iran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 7667
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Khodabakhsh Javanshir
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
University of Medical Sciences , Ganjafrooz Street , Babol , Mazandaran ,Iran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 32194641
Email
kjavanshir@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Roghayeh Mousavi-khatir
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation,University of Medical Sciences , Ganjafrooz Street , Babol , Mazandaran ,Iran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 4641
Email
r-mousavi@mubabol.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Roghayeh Mousavi-Khatir
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
ُSchool of Rehabilitation, University of Medical Sciences , Ganjafrooz Street , Babol , Mazandaran ,Iran
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 4641
Email
r-mousavi@mubabol.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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