comparison of the effects of suboccipital myofascial release and diaphragm myofascial release on pain intensity and frequency and quality of life in patients with symptomatic tension-type headache aged 18-40 years.
Design
a controlled, double group, single blinded(assessor), randomized(randomizer site), phase 3 clinical trial on 22 patients.
Settings and conduct
The study is carried out at Shiraz's school of rehabilitation sciences, comparing the effects of added value of diaphragm myofascial release and sub-occipital release on tension type headache. Manual techniques are applied thrice a week for 2 weeks. blinding of evaluator is maintained by separating treatment and assessment roles.
Participants/Inclusion and exclusion criteria
Age range: 18 to 40 years, Headache lasting from 30 min to 7 days, At least two of the following pain characteristics:
1. Bilateral location
2. Pressing or tightening (non-pulsating) quality
3. Mild or moderate intensity
4. Not aggravated by routine physical activity, such as walking or climbing stairs
Both of the following:
1. No nausea, vomiting (anorexia can occur)
2. No more than one of photophobia or phonophobia not attributed to another disorder
People with CTTH who had headache for at least 3 days in a week for the past four Consecutive weeks (48).
tenderness over the suboccipital region (88) and diaphragm
Intervention groups
one of the intervention groups will receive suboccipital muscle release and diaphragm, and the other group will receive sub-occipital release only.
Main outcome variables
pain intensity, pain frequency, quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250629066291N3
Registration date:2026-05-18, 1405/02/28
Registration timing:prospective
Last update:2026-05-18, 1405/02/28
Update count:0
Registration date
2026-05-18, 1405/02/28
Registrant information
Name
Farzaneh Haghighat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3230 5410
Email address
haghighat_fa@yahoo.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-06-06, 1405/03/16
Expected recruitment end date
2026-12-07, 1405/09/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Added Value of Diaphragmatic Myofascial Release in the Management of Chronic Tension-Type Headache: A Randomized Controlled Trial
Public title
Added Value of Diaphragmatic Myofascial Release in the Management of Chronic Tension-Type Headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range: 18 to 40 years
Headache lasting from 30 min to 7 days.
3. At least two of the following pain characteristics:1. Bilateral location2. Pressing or tightening (non-pulsating) quality 3. Mild or moderate intensity 4. Not aggravated by routine physical activity, such as walking or climbing stairs
People with CTTH who had headache for at least 3 days in a week for the past four Consecutive weeks
No nausea, vomiting (anorexia can occur)
No more than one of photophobia or phonophobia not attributed to another disorder
Exclusion criteria:
Visual or hearing impairment
Nervous system disorders
Balance disorders
cervical disk herniation
History of surgery in the neck and spine area
A history of additional migraine headache or secondary headaches
History of any trauma to the cervical spine, such as whiplash injury
Cognitive disorders
Inflammatory diseases such as rheumatoid arthritis
History of any fracture in the neck area
Congenital neck abnormalities (torticollis)
Respiratory diseases and shingles
Professional athletes
Cervical spinal canal stenosis
Radicular pain related to the neck area
Malignancy
Fibromyalgia
pregnant or breastfeeding
Undergoing physiotherapy treatment within the last six months
Use of painkillers, anti-inflammatory drugs, or muscle relaxants within the past 72 hours
Age
From 18 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
Care provider
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Randomized
Randomization description
The random assignment method in this study will be the blocked permutation method (number of blocks 8 and block size 4) which will be generated using randomizer site The samples will be assigned in a 1:1 ratio. Opaque, sealed envelopes will be used to conceal the assignment.
Blinding (investigator's opinion)
Single blinded
Blinding description
The individual who performs the assessments is separate from the one who administers the treatments, and neither is aware of the other's work. The person responsible for randomization is also independent from both of the aforementioned individuals.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Ethics committee, Research and Technology Vice-Chancellor, 7th floor, Central building of Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Province
Fars
Postal code
7198754361
Approval date
2026-01-10, 1404/10/20
Ethics committee reference number
IR.SUMS.REC.1404.581
Health conditions studied
1
Description of health condition studied
tension-type headache
ICD-10 code
G44.2
ICD-10 code description
Tension-type headache
Primary outcomes
1
Description
pain intensity
Timepoint
before intervention, after intervention period.
Method of measurement
numerical pain rating scale
2
Description
headache frequency
Timepoint
4 weeks before intervention, 1 week after intervention period
Method of measurement
interview and headache records
3
Description
quality of life
Timepoint
before intervention, 1 week after intervention
Method of measurement
headache disability index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: diaphragm release and suboccipital release: To release the diaphragm, the patient is positioned in the supine position. The therapist stands at the head of the patient. The therapist makes manual contact bilaterally under the costal cartilages of the lower ribs (7th to 10th ) with hypothenar regions of the hands and last three fingers. During the patient’s inspiration, the therapist is gently pulling the points of hands contacts toward the head and slightly laterally, while elevating the ribs simultaneously. During exhalation, the therapist deepens hand contacts towards the inner costal margins. The release technique is performed thrice a week for two weeks; each technique lasts for 5 to 7 minutes. All release techniques will be done by the same physiotherapist. For suboccipital release technique, the patient is asked to lie down in a relaxed supine position on the treatment table while the therapist sits on a chair at the head of the patient. The therapist's elbows are supported by the table, and their forearms are positioned in supination. The patient is then instructed to rest their head on the therapist's palms. Next, the therapist places the pads of four fingers of both hands on either side of the C2 vertebra, just below the occipital region, and applies pressure until a melting sensation is felt. The intervention lasts four minutes. During this technique, the patient is asked to close both eyes to prevent eye movements, which could affect the tone of the sub occipital muscles. This technique is performed three times a week for two weeks for each patient in this group.
Category
Treatment - Other
2
Description
Intervention group: For suboccipital release technique, the patient is asked to lie down in a relaxed supine position on the treatment table while the therapist sits on a chair at the head of the patient. The therapist's elbows are supported by the table, and their forearms are positioned in supination. The patient is then instructed to rest their head on the therapist's palms. Next, the therapist places the pads of four fingers of both hands on either side of the C2 vertebra, just below the occipital region, and applies pressure until a melting sensation is felt. The intervention lasts four minutes. During this technique, the patient is asked to close both eyes to prevent eye movements, which could affect the tone of the sub occipital muscles. This technique is performed three times a week for two weeks for each patient in this group.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of rehabilitation school, Shiraz university of medical sciences
Full name of responsible person
Farzaneh Haghighat
Street address
Mehr building, Shahid chamran hospital, Shahid chamran boulevard, Shiraz
City
Shiraz
Province
Fars
Postal code
7194815644
Phone
+98 71 3624 0101
Fax
Email
rehabdep@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hamid Mohammadi
Street address
Research and Technology vice-chancellor, 7th floor, Central building of Shiraz University of Medical Sciences, Zand street, Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Haghighat
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Chamran Blvd
City
Shiraz
Province
Fars
Postal code
7194815644
Phone
+98 71 3230 5410
Fax
Email
Haghighat_fa@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Haghighat
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Chamran Blvd
City
Shiraz
Province
Fars
Postal code
7194815644
Phone
+98 71 3230 5410
Fax
Email
Haghighat_fa@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Haghighat
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Chamran Blvd
City
Shiraz
Province
Fars
Postal code
7194815644
Phone
+98 71 3230 5410
Fax
Email
Haghighat_fa@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
information collection form including primary and secondary outcomes, informed consent form and SSPS file.
When the data will become available and for how long
After publication of the results of the study
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Only for recording information in scientific databases
From where data/document is obtainable
correspondence with the project manager by email.
Haghighat_fa@yahoo.com
What processes are involved for a request to access data/document
Maximum one month after sending the request by email.