An interventional study of Multi-Segmental Spinal Manual Therapy in Migraine Disorders, sponsored by Borna Farhoomand. Not yet recruiting. Open to female participants aged 18 Years to 30 Years. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Borna Farhoomand · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate the clinical effects of multi-segmental spinal manual therapy on pain intensity, central sensitization (CS), and sensorimotor control in women diagnosed with episodic migraine (EM).
Participants receive 10 sessions of a comprehensive manual therapy intervention targeting the cervical, thoracic, lumbar, and sacral regions over a 2-week period. Clinical outcomes-including headache pain intensity, sensorimotor dysfunction, headache-related disability, and cutaneous allodynia-are evaluated at baseline, immediately after the 2-week treatment, and at a 1-month follow-up.
This study aims to investigate whether addressing multiple spinal segments with manual therapy improves clinical symptoms, spinal motor control, and central pain processing in female individuals with EM.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's planned enrollment of 10 is below the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Borna Farhoomand is the lead sponsor of 5 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a multi-segmental spinal manual therapy intervention targeting the cervical, thoracic, lumbar, and sacral regions. The protocol will consist of 10 sessions conducted over a 2-week period (5 sessions per week, each lasting approximately 30 to 45 minutes). Treatment will include passive joint mobilizations (specifically Mulligan Concept techniques) applied across spinal segments and soft tissue mobilization techniques targeted specifically at the cervical region, tailored to baseline examination findings. No high-velocity low-amplitude thrust manipulations will be administered.
Procedure: Multi-Segmental Spinal Manual Therapy
The intervention protocol will consist of 10 individual sessions delivered over 2 consecutive weeks (5 sessions per week, approximately 30 to 45 minutes per session). The treatment will include two primary components: 1. Multi-segmental Spinal Joint Mobilizations: Passive joint mobilization techniques (specifically Mulligan Concept techniques, such as Mobilization with Movement and Natural Glides) applied to the cervical, thoracic, lumbar, and sacral regions based on baseline physical examination findings. High-velocity low-amplitude thrust manipulations will not be performed. 2. Cervical Soft Tissue Mobilization: Soft tissue mobilization and myofascial techniques targeted specifically to the cervical and suboccipital musculature. All procedures will be administered by a licensed physical therapist in a standardized clinical setting.
Headache Intensity Assessed via Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) will be used in this study to assess headache intensity. It is defined as a 10-cm line anchored at one end by "no pain" (a value of 0) and at the other end by "severe, unbearable pain" (a value of 10), yielding a total score ranging from 0 to 10 (where 0 indicates no pain and 10 indicates the worst imaginable pain; higher scores indicate a worse outcome). Patients will be asked to rate their pain intensity before and after the intervention by placing a vertical mark on the line corresponding to their perceived pain level. This clinical pain assessment method has generally been reported to be reliable and valid, providing a robust and reproducible way for patients to express pain intensity, with results shown to correlate well with other pain measurement methods. It can be applied regardless of language and used by individuals aged 5 years and older.
Time frame: Baseline, Immediately after completion of treatment at Week 2, and 1-month follow-up.
Headache-Related Disability Grade Assessed via Migraine Disability Assessment (MIDAS) Questionnaire.
The Migraine Disability Assessment (MIDAS) questionnaire, originally developed by Stewart et al. and validated in Turkish by Ertaş et al. (Cronbach's alpha = 0.87), was used to evaluate headache-related functional disability. The instrument comprises five items that quantify the total number of days with lost or substantially reduced performance across work, school, and household activities over the preceding three months. The MIDAS total score is calculated by summing the reported lost days (range: 0 to 270 days, where higher scores indicate greater headache-related disability/worse outcome). Overall scores are categorized into four severity grades: Grade I (0-5 days; little or no disability), Grade II (6-10 days; mild disability), Grade III (11-20 days; moderate disability), and Grade IV (21 days or more; severe disability).
Time frame: Baseline, Immediately after completion of treatment at Week 2, and 1-month follow-up.
Cutaneous Allodynia Severity Assessed via Allodynia Symptom Checklist (ASC-12).
Cutaneous allodynia severity will be assessed using the Allodynia Symptom Checklist-12 (ASC-12), Turkish-adapted by Yalın et al. in 2017 (37). The ASC-12 consists of 12 items assessing symptoms of static, dynamic, and thermal allodynia. Items are answered using the responses "Not applicable to me," "Never," "Rarely," "Less than half the time," and "Half the time or more." The total score is calculated by assigning 0 points for "Not applicable to me," "Never," and "Rarely"; 1 point for "Less than half the time"; and 2 points for "Half the time or more," yielding a total score ranging from 0 to 24 (where higher scores indicate a greater degree of cutaneous allodynia/worse outcome). A score of 0-2 indicates the absence of cutaneous allodynia, whereas scores above 2 indicate its presence-specifically, 3-5 indicates "mild cutaneous allodynia," 6-8 indicates "moderate cutaneous allodynia," and 9-24 indicates "severe cutaneous allodynia."
Time frame: Baseline, Immediately after completion of treatment at Week 2, and 1-month follow-up.
Sensorimotor Dysfunction Score Assessed via Sensory-Motor Dysfunction Questionnaire (SMD-Q).
Sensorimotor dysfunctions-including impairments in balance, proprioception, motor performance, and multimodal processing-were assessed using the Sensory-Motor Dysfunction Questionnaire (SMD-Q), originally developed by Ambalavanar et al. and validated in Turkish by Arslan et al. (Cronbach's alpha = 0.85). The questionnaire evaluates discrepancies between motor intent and sensory feedback via 12 items, each scored on a 4-point Likert scale (0 to 3) based on weekly symptom frequency. The total score is calculated by summing item responses (range: 0 to 36, where higher scores indicate greater sensorimotor dysfunction/worse outcome).
Time frame: Baseline, Immediately after completion of treatment at Week 2, and 1-month follow-up.
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Plan to share: No
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Borna Farhoomand