The effectiveness of deep neck flexor exercises in comparison with myofascial release of suboccipital muscle on pain and forward head posture in people with chronic tension type headache and forward head posture
Comparison of the effectiveness of deep neck flexor exercises with suboccipital muscle myofascial release on headache parameters, forward head posture, disability, quality of life, and pressure pain threshold of sub-occipital muscles in patients with chronic tension-type headache and forward head posture
Design
A double-blind (patients and assessor), randomized by block balanced randomization method and the generatorslist.com system, double-dummy design controlled clinical trial of 44 patients.
Settings and conduct
Patients are referred by a neurologist to a physiotherapy clinic under the auspices of the Iran University of Medical Sciences in Tehran. The treatment is applied in 12 sessions in two groups. outcomes assessment will be performed before and after the sessions and again 6 weeks later. The blinding method is double-blind (patients and evaluators).
Participants/Inclusion and exclusion criteria
Inclusion criteria: 18 to 55 years; Diagnosis of chronic tension headache according to the International Headache Committee; No change in dose and type of prophylactic medication 3 months before the start and during the study; Craniovertebral angle less than 49 degrees
Exclusion criteria: History of cervical trauma; Severe pain or severely limited range of motion of the neck; History of injection, surgery, severe disc herniation or neck/shoulder fracture; Joint stiffness or advanced osteoarthritis of the neck; Neurological or vascular disorders; Consumption of strong analgesics more than 200 per month; Pregnancy; Score more than 85 in Spielberger Anxiety Questionnaire
Intervention groups
One group: deep neck flexor exercises with pressure biofeedback combined with placebo suboccipital myofascial release
another group: suboccipital myofascial release combined with placebo deep neck flexor exercises.
Main outcome variables
headache intensity; severity of the forward head posture
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220219054060N1
Registration date:2022-04-21, 1401/02/01
Registration timing:registered_while_recruiting
Last update:2022-04-21, 1401/02/01
Update count:0
Registration date
2022-04-21, 1401/02/01
Registrant information
Name
Mobina Ahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3312 6087
Email address
ahmadi.mobi@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of deep neck flexor exercises in comparison with myofascial release of suboccipital muscle on pain and forward head posture in people with chronic tension type headache and forward head posture
Public title
The effectiveness of exercises in comparison with manual treatments in chronic tension type headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with at least 2 of the 4 characteristics of bilateral headache, Non-pulsatile pain pressure, mild to moderate severity and no aggravation of pain by daily activities such as walking
People who have experienced the headache for at least 3 months
People who have the headache more than 15 days per month
People who have only one of the symptoms of photophobia, phonophobia or mild nausea
People with a craniovertebral angle less than 49 degrees
The dose and type of prophylactic medication have not changed in the last 3 months
People who do not intend to change the dose and type of prophylactic medication during the study period
Participants have completed at least the elementary level of education and have the ability to understand and read Persian to complete the questionnaire.
The headache can be accompanied by muscles tenderness around the head and neck
Exclusion criteria:
People with dizziness, severe nausea or vomiting due to the headache
People with episodic tension type headache or other primary and secondary headaches
Pain aggravated by movement of the head
َAbnormal changes in the radiographic image of cervical spine
Previous trauma to the cervical spine
Severe pain or significant limitation of the normal range of motion of the cervical spine
History of injection, surgery, severe disc protrusion, or neck or shoulder fracture that affects treatment
Joint stiffness, atherosclerosis or advanced osteoarthritis of the cervical spine
Neurological or vascular disorders such as epilepsy or Bow hunter’s syndrome
Absence of two consecutive sessions and more than treatment sessions
Consume more than 200 pieces of morphine or other strong analgesics per month
Pregnancy
Receive physiotherapy treatment for headache within 6 months before starting treatment
People who drink alcohol or have drug abuse
For whatever reason, the participant is reluctant to be touched by the therapist
Symptoms are severe and irritating
Underlying diseases (such as rheumatoid arthritis) or metabolic disorders (such as osteoporosis or soft tissue laxity in the treatment area) for which manual therapies are contraindacated
Score is more than 85 in the Spielberger Anxiety Trait Questionnaire
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
All eligible patients with chronic tension-type headache are randomly divided into two groups of treatment: deep neck flexor exercise and myofascial release groups with a 1: 1 ratio. Generatorslist.com is used to determine random allocation; This method is done with the help of four-digit blocks including even and odd numbers. For this purpose, 4-digit numbers are selected that have 2 even digits and 2 odd digits; Each digit represents each participant in the study.
The random allocation process will be performed by someone outside the research team before the study begins. At the end of the random allocation, the numbers will be placed inside the numbered envelopes separately and after the initial evaluation by the examiner, the numbered envelopes will be given according to the ordinal number of each person entered in the study. Finally, after each participant enters the treatment sessions, the therapist opens the envelope of the participants and applies therapeutic interventions based on the number in the envelope.
Patients are told not to provide information about their group to the assessor to prevent data contamination.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants, the outcome assessor, and, the statistician will be blinded.
Method of blindness:
a) Participants: In each of the treatment groups, a real treatment was used with the placebo form of treatment of another group (the first group includes deep neck flexor exercise with placebo myofascial release, and the second group includes suboccipital myofascial release with placebo deep neck flexor exercise) so that the participants could not guess which treatment group they had entered; also, the participants will not be aware of how the other group will be treated.
B) Outcome Assessor: Outcome assessment will be performed by a person who has no knowledge of the grouping of individuals and the treatments performed in each treatment group.
C) Statistician: Data analysis will be performed by a person who does not know the grouping of people and the treatments performed in each treatment group.
Placebo
Used
Assignment
Parallel
Other design features
This randomized clinical trial is of the double-dummy type. in this way, one group will receive deep neck flexor exercises with placebo treatment of myofascial release of suboccipital muscles and the other group will receive myofascial release of suboccipital muscles with placebo treatment of deep neck flexor exercises.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Iran University of Medical Sciences
Street address
Unit 2,First Floor,Golestan Dormitory, Iran School of Rehabilitation, Maddakaran St., Shah Nazari St., Madar Sq., Mirdamad Blvd.
City
Tehran
Province
Tehran
Postal code
1545913487
Approval date
2022-03-16, 1400/12/25
Ethics committee reference number
IR.IUMS.REC.1400.1239
Health conditions studied
1
Description of health condition studied
chronic tension-type headache
ICD-10 code
G44.221
ICD-10 code description
Chronic tension-type headache, intractable
Primary outcomes
1
Description
The average severity of headache during the last 1 month
Timepoint
Pain intensity will be measured at the beginning of the study (before the intervention), after the end of 12 sessions of treatment and 6 weeks after the end of the intervention.
Method of measurement
Visual Analogue Scale
2
Description
the severity of forward head posture
Timepoint
Measurement of the forward head posture will be performed at the beginning of the study (before the start of the intervention), after the end of 12 sessions of treatment and 6 weeks after the end of the intervention.
Method of measurement
Craniovertebral angle: The angle between the horizon line and the line connecting the tragus of the ear to the spinous process of the seventh cervical vertebra
Secondary outcomes
1
Description
Duration of the headache
Timepoint
The duration of headache will be measured at the beginning of the study (before the intervention), after the end of 12 sessions of treatment, and 6 weeks after the end of the intervention.
Method of measurement
The average number of hours that a person has the headache in a month.
2
Description
ّFrequency of the headache
Timepoint
The frequency of headaches will be measured at the beginning of the study (before the intervention), after the end of 12 sessions of treatment and 6 weeks after the end of the intervention.
Method of measurement
The number of days in the month when a person has a headache.
3
Description
Disability
Timepoint
Disability will be assessed at the beginning of the study (before the intervention), after the end of 12 sessions of treatment, and 6 weeks after the end of the intervention.
Method of measurement
Persian version of the Henry Ford Hospital Headache Disability Inventory questionnaire
4
Description
Quality of life
Timepoint
Quality of life will be assessed at the beginning of the study (before the intervention), after the end of 12 sessions of treatment, and 6 weeks after the end of the intervention.
Method of measurement
Persian version of Headache Impact Test questionnaire -6
5
Description
Pressure Pain Threshold of suboccipital muscles
Timepoint
The pressure Pain Threshold of suboccipital muscles will be assessed at the beginning of the study (before the intervention), after the end of 12 sessions of treatment, and 6 weeks after the end of the intervention.
Method of measurement
Algometer device in the lower part of the occipital bone and outside the upper head of the upper trapezius muscle on both sides
Intervention groups
1
Description
Intervention group 1: deep neck flexor exercises with pressure biofeedback combined with placebo myofascial release of suboccipital muscles
Category
Rehabilitation
2
Description
Intervention group 2:sub-occipital myofascial release combined with placebo deep neck flexor exercises with pressure biofeedback.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Mansoureh Togha
Street address
Unit 2, First Floor, Golestan Dormitory, Iran School of Rehabilitation, Maddakaran St., Shah Nazari St., Madar Sq., Mirdamad Blvd.
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2225 6434
Email
m.oahmadi@ymail.com
2
Recruitment center
Name of recruitment center
Physiotherapy Clinic, School of Rehabilitation, Iran University of Medical Sciences
Full name of responsible person
Mohammadreza Pourahmadi
Street address
Department of Physiotherapy, Faculty of Rehabilitation Sciences of Iran University of Medical Sciences, Maddakaran St., Shah Nazari St., Madar Sq., Mirdamad Blvd.
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 912 224 5593
Email
pourahmadipt@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Keyvani Hossein
Street address
Fifth floor of the headquarters, Iran University of Medical Sciences, Next to Milad Tower, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
keyvani.h@iums.ac.ir
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
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
Iran University of Medical Sciences
Full name of responsible person
Mobina Ahmadi
Position
Master of Science student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Unit 2, First Floor, Golestan Dormitory, Iran School of Rehabilitation, Maddakaran St., Shah Nazari St., Madar Sq., Mirdamad Blvd.
City
Tehran
Province
Tehran
Postal code
1545912487
Phone
+98 21 2225 6434
Email
m.oahmadi@ymail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammadreza Pourahmadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Department of Physiotherapy, Faculty of Rehabilitation Sciences of Iran University of Medical Sciences, Maddakaran St., Shah Nazari St., Madar Sq., Mirdamad Blvd.
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 2059
Email
pourahmadipt@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mobina Ahmadi
Position
Master of Science student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Unit 2, First Floor, Golestan Dormitory, Iran School of Rehabilitation, Maddakaran St., Shah Nazari St., Madar Sq., Mirdamad Blvd.
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2225 6434
Email
m.oahmadi@ymail.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
Data collected after unidentifiable individuals are collected for primary and secondary outcomes and shared as needed.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
The data will be available to physiotherapists working in scientific institutions as well as clinicians working in the field of musculoskeletal disorders, especially in the head and cervical regions.
Under which criteria data/document could be used
The raw data and results of this study may be used in systematic studies. Hence, the raw data and results of this study will be available to researchers working in the field of headache.
From where data/document is obtainable
Applicants can contact Mobina Ahmadi (Physiotherapist) by e-mail. Email address: m.oahmadi@ymail.com
What processes are involved for a request to access data/document
Applicants must explain in detail about their project and how to use the data/documentation of this study in their project. Then, the data/documentation files will be sent to the applicants through e-mail following the request. This process may take 10-12 business days.