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IRCT20250629066291N6 IRCT 2026-09-17 Shiraz University of Medical Sciences Added-value of Myofascial Diaphragmatic Release to the Neck Muscles Trigger Points in the Management of Chronic Migraine a Randomized Clinical Trial Added-value of Myofascial Diaphragmatic Release to the Neck Muscles Trigger Points in the Management of Chronic Migraine a Randomized Clinical Trial 2026-09-23 anticipated 50 Recruiting https://irct.ir/trial/93150 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization with a fixed block size of 4 and a 1:1 allocation ratio will be used. Thus, each block of 4 participants will contain 2 allocations to intervention A and 2 to intervention B, with the allocation sequence randomly determined within each block. However, as a total sample size of 50 participants cannot be evenly randomized using blocks of 4 alone, combined block sizes will be used (e.g., twelve blocks of 4 plus a final block of 2, or randomly varying block sizes of 4 and 6), Blinding description: The assessors will be blinded to the randomization process, which will be performed by an independent researcher. Assessment and intervention procedures will be conducted by two separate physiotherapists to minimize the risk of bias. N/A Chronic migraine headaches. Intervention 1: Control group:. Intervention 2: Intervention 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
Mehr Building, Shahid Chamran Hospital, Shahid Chamran Boulevard
Shiraz Iran (Islamic Republic of) 7194815644 +98 71 3624 0101 haghighat_fa@yahoo.com Shiraz University of Medical Sciences scientific Farzaneh Haghighat
Mehr Building, Shahid Chamran Hospital, Shahid Chamran Boulevard
Shiraz Iran (Islamic Republic of) 7194815644 +98 71 3624 0101 haghighat_fa@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Age 25–55 years Chronic migraine (>3 months) diagnosed according to the International Headache Society (IHS) criteria by a neurologist. At least one active trigger point in the sternocleidomastoid, upper trapezius, or suboccipital muscles reproducing headache pain (active trigger points defined by tenderness, referred pain, and a local twitch response on palpation). 25 years 55 years Both History of neck trauma Cervical radiculopathy History of neck or shoulder surgery Diagnosis of other headache disorders Trigger point treatment in the cervical region within the previous 6 months Rheumatologic disorders, dizziness, hypertension, psychological stress, psychological disorders, cardiopulmonary diseases, or pregnancy G43 Migraine Treatment - Other Treatment - Other Control group: Intervention group: Pain intensity. Timepoint: Mean over the week preceding and the week following the treatment period. Method of measurement: One week before treatment initiation, at the first visit of the participants for assessment of the inclusion and exclusion criteria, they will be provided with a Daily Headache Diary containing a Visual Analog Scale (VAS). They will be asked to record their headache intensity each day for 1 week by marking a point on the 10-cm VAS line according to the intensity of their headache, ranging from 0 (indicating no pain) to 10 (indicating the maximum pain). The Daily Headache Diary will be collected one week later, at the first treatment session. After accurately measuring the distance from the zero point to the marked point for each day, the mean daily headache intensity over the 1-week period will be calculated. At the end of the final treatment session, another similar Daily Headache Diary will be provided to the participants, and they will again be asked to mark their headache intensity each day using the same method. This Daily Headache Diary will also be collected one week later, and the mean daily headache intensity will again be calculated using the method described above. Finally, two numerical values representing the mean headache intensity measured by the VAS will be obtained and statistically compared. Disability. Timepoint: At baseline (before the first treatment session) and one day after the final treatment session. Method of measurement: Quality of life will be assessed using the Migraine-Specific Quality of Life Questionnaire (MSQ). This questionnaire is a well-established instrument that has been widely used in research and clinical practice to assess quality of life (QOL) (167). The MSQ version 2.1 consists of 14 questions, with each question having 6 response options, with a total score of 100. Higher scores on this questionnaire indicate better quality of life. The questionnaire will be completed by the participants and collected from them twice: first, at the first treatment session before the treatment begins, and second, one day after the final treatment session. Quality of life. Timepoint: At baseline (before the first treatment session) and one day after the final treatment session. Method of measurement: Quality of life will be assessed using the Migraine-Specific Quality of Life Questionnaire (MSQ). This questionnaire is a well-established instrument that has been widely used in research and clinical practice to assess quality of life (QOL) (167). The MSQ version 2.1 consists of 14 questions, with each question having 6 response options, with a total score of 100. Higher scores on this questionnaire indicate better quality of life. The questionnaire will be completed by the patients and collected from them twice: first, at the first treatment session before the treatment begins, and second, one day after the final treatment session. Mean headache duration. Timepoint: During the week before treatment initiation and the week following treatment. Method of measurement: One week before treatment initiation, that is, at the first visit of the patient for assessment of the inclusion and exclusion criteria, a Daily Headache Diary will be provided to the patients, and they will be asked to record the duration of their headache each day for 1 week in the column designated for daily headache duration. The Daily Headache Diary will be collected from the patients one week later, that is, at the first treatment session, and the mean daily headache duration over the 1-week period will be calculated. At the end of the final treatment session, another similar Daily Headache Diary will be provided to the patients, and they will again be asked to record their headache duration each day using the same method. This Daily Headache Diary will also be collected from the patients one week later, and the mean daily headache duration will be calculated. Daily headache frequency. Timepoint: During the week before treatment initiation and the week following treatment. Method of measurement: One week before treatment initiation, that is, at the first visit of the patient for assessment of the inclusion and exclusion criteria, a Daily Headache Diary will be provided to the patients, and they will be asked to record the number of headache episodes occurring each day for 1 week in the column designated for the number of daily headache episodes. The Daily Headache Diary will be collected from the patients one week later, that is, at the first treatment session, and the mean daily headache frequency over the 1-week period will be calculated. At the end of the final treatment session, another similar Daily Headache Diary will be provided to the patients, and they will again be asked to record the number of headache episodes occurring each day using the same method. This Daily Headache Diary will also be collected from the patients one week later, and the mean number of daily headache episodes will be calculated. Type and dosage of the medication. Timepoint: During the week before treatment initiation and the week following treatment. Method of measurement: The type of medication used by each patient and the dosage taken, according to the prescription of their treating physician, will be recorded and documented in the aforementioned Daily Headache Diary for review and, if necessary, statistical analysis. Shiraz University of Medical Sciences Approved 2026-07-12 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)