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IRCT20250629066291N3 IRCT 2026-05-18 Shiraz University of Medical Sciences Added Value of Diaphragmatic Myofascial Release in the Management of Chronic Tension-Type Headache Added Value of Diaphragmatic Myofascial Release in the Management of Chronic Tension-Type Headache: A Randomized Controlled Trial 2026-06-06 anticipated 22 Recruiting https://irct.ir/trial/89223 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 tension-type headache. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: information collection form including primary and secondary outcomes, informed consent form and SSPS file. When: After publication of the results of the study To whom: Researchers working in academic and scientific institutions Conditions: Only for recording information in scientific databases Where to obtain: correspondence with the project manager by email. Haghighat_fa@yahoo.com How to obtain: Maximum one month after sending the request by email. Comments:
public Farzaneh Haghighat
Chamran Blvd
Shiraz Iran (Islamic Republic of) 7194815644 +98 71 3230 5410 Haghighat_fa@yahoo.com Shiraz University of Medical Sciences scientific Farzaneh Haghighat
Chamran Blvd
Shiraz Iran (Islamic Republic of) 7194815644 +98 71 3230 5410 Haghighat_fa@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) 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 18 years 40 years Both 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 G44.2 Tension-type headache Treatment - Other Treatment - Other 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. 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. Pain intensity. Timepoint: before intervention, after intervention period. Method of measurement: numerical pain rating scale. Headache frequency. Timepoint: 4 weeks before intervention, 1 week after intervention period. Method of measurement: interview and headache records. Quality of life. Timepoint: before intervention, 1 week after intervention. Method of measurement: headache disability index. Shiraz University of Medical Sciences Approved 2026-01-10 Ethics committee of Shiraz University of Medical Sciences Ethics committee, Research and Technology Vice-Chancellor, 7th floor, Central building of Shiraz University of Medical Sciences, Zand Street Shiraz Fars Iran (Islamic Republic of)