The aim of this study was to evaluate the effect of neurophysiological pain education on the treatment of people with neck headache and compare it with conventional physiotherapy.
Design
In this study, a parallel single-blind clinical trial of 30 patients with headache of cervical origin participates Which are randomly divided into experimental and control groups by blocking method.
Settings and conduct
This study will be performed on patients with cervicogenic headache referred to neurology clinics and physiotherapy centers dependent to Isfahan Medical University.In this study, evaluators are blind to groups.
Participants/Inclusion and exclusion criteria
This study was performed on patients with headache of cervical origin referred to internal neurology clinics and physiotherapy affiliated to Isfahan University of Medical Sciences who are eligible for inclusion in the study.
Intervention groups
Treatment in the Pain Neurophysiology Education Group: it will be easy to explain using simple methods such as presentation with PowerPoint slides, pain transfer methods over 4 one hour sessions and one session per week. will be given.
Conventional Physical Therapy: TENS is used to relieve pain and ultrasound, as well as exercise therapy in both groups.
The effect of Pain Neurophysiology Education in the treatment of Cervicogenic headache: A randomized clinical trial
Public title
The effect of Pain Neurophysiology Education in the treatment of Cervicogenic headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Unilateral headache that spreads to the frontotemporal region.
Pain exacerbation associated with movement or inappropriate neck postures.
Moderate to severe non-pulsatile pain based on Numeric Rating Pain Scale not lower than grade 2
Enough reading and writing skills are also a requirement for inclusion.
Exclusion criteria:
Neck Radiculopathy
History of neck injury
Any other neck pain agent, including osteoarthritis
History of cervical trigger point treatment by manual or dry needle treatment over the past 6 months
Cognitive disorders
Previous history of primary headache diagnosis (such as migraine and tension headache)
Use of painkillers during treatment
Previous history of neck or shoulder surgery
Failure to co-operate
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, due to the small number of samples, in consultation with a statistician, it was decided to use the random blocking method. Blocking is usually used to balance the number of samples assigned to each of the groups studied.
Statistics expert using the website
https://www.sealedenvelope.com/simple-randomiser/v1/lists 15 blocks of 2 were designed considering that we had 2 groups.
Divides patients according to this table is unaware of the study.
Blinding (investigator's opinion)
Single blinded
Blinding description
Assessments are performed by a person who is unaware of the groups.
After completing the questionnaires, the subjects were randomly divided into two groups with block method by one person who was unaware of the study
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan Medical University
Street address
Hezar Jrib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-08-04, 1399/05/14
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.301
Health conditions studied
1
Description of health condition studied
Cervicogenic Headache
ICD-10 code
G44.8
ICD-10 code description
Other specified headache syndromes
Primary outcomes
1
Description
pain intensity
Timepoint
Before and after treatment and one month follow up
Method of measurement
Visual Analog Scale
2
Description
Pain frequency
Timepoint
Before and after treatment and one month follow up
Method of measurement
Questionnaire
3
Description
Pain Duration
Timepoint
Before and after treatment and one month follow up
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Headache Disability Inventory
Timepoint
Before and after treatment and one month follow up
Method of measurement
Headache Disability Inventory
2
Description
Pain Catastrophizing rate
Timepoint
Before and after treatment and one month follow up
Method of measurement
Pain Catastrophizing Scale
Intervention groups
1
Description
Intervention group: Pain Neurophysiology Education: This method is taught to patients by the student. In the pain neurophysiology group, the training will be such that using simple methods such as presenting with PowerPoint slides, pain transfer methods will be explained in 4 sessions of one hour and one session per week in a simple way. Pain neurophysiology training based on the book Explain pain supercharged by G.L. Mosely and D.S. It will be Butler. This training includes explanations of the origin of acute pain in the nervous system, how to change acute pain to chronic, central sensitivity, the role of the brain in perceiving pain, psychosocial factors affecting pain and cognitive and behavioral reactions related to pain and pain management. There is no reference to the anatomy and mechanics of the neck in these sessions.
Category
Treatment - Other
2
Description
Control group: Conventional Physiotherapy: This method is applied by a physiotherapist in the physiotherapy department. In this group, for 10 sessions, use Conventional TENS with a frequency of 100 Hz with a duration of 100 microseconds for 20 minutes. The electrode will be placed so that two electrodes from one channel are placed on the paravertebral muscles of the neck and two electrodes from the other channel are placed on the upper trapezius muscles. The hot pack will also be used at the same time as using TENS on the electrodes. In addition, Continuous ultrasound waves with a frequency of 1 MHz and an intensity of 1 w / cm2 will be used for 5 minutes on the posterior muscles of the upper vertebrae. It also teaches the patient exercise therapy using active exercises.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Dr. Mohammad Reza Najafi
Street address
Esfahan - Shahid Keshvari Highway - Safa Boulevard - Alzahra Medical Center
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 1668 5555
Fax
+98 31 1668 4510
Email
alzahra@mui.ac.ir
Web page address
http://alzahra.mui.ac.ir
2
Recruitment center
Name of recruitment center
kashani hospital
Full name of responsible person
Dr. Majid Ghasemi
Street address
Ayatollah Kashani Main Street
City
Isfahan
Province
Isfehan
Postal code
۸۳۴۳۴-۸۱۸۳۹
Phone
+98 31 3233 0093
Fax
+98 31 1233 5030
Email
kashani@mui.ac.ir
Web page address
http://kashani.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Haghjoo Javanmard
Street address
Hezar Jarib Street, Isfahan University of Medical Sciences, Staff Building No. 4 - Vice chancellor for research
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3668 5149
Email
research@mui.ac.ir
Web page address
https://research.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
Dr. Ehsan Ghasemi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Hezar jreeb Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3669 3089
Fax
+98 31 3668 7270
Email
eghasemi@rehab.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Ehsan Ghasemi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Hezar Jreeb Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3669 3089
Fax
+98 31 3668 7270
Email
eghasemi@rehab.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Ehsan Ghasemi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Hezar Jreeb Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3669 3089
Email
eghasemi@rehab.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
We are not able to publish data ethically and misuse information.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The study protocol and consent form are included in the proposal.Clinical results will be published after the end of study.
When the data will become available and for how long
The study protocol and the name consent form are already available.
Clinical results will be published in the summer of 1400.
To whom data/document is available
Researchers working in scientific institutes and patients.
Under which criteria data/document could be used
To increase information.
From where data/document is obtainable
See Dr. Ehsan Ghasemi.
What processes are involved for a request to access data/document