Migraine DisordersNCT07774286
Multi-Segmental Spinal Manual Therapy in Women With Episodic Migraine
A study testing Multi-Segmental Spinal Manual Therapy in people with Migraine Disorders, run by Borna Farhoomand.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- Multi-Segmental Spinal Manual Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients aged 18-30 years,
- Diagnosis of episodic migraine established by a specialist neurologist,
- Headache frequency of <15 days per month,
- Pain intensity score of ≥40 mm on the Visual Analog Scale (VAS),
- Absence of any diagnosed psychiatric disorders,
- Literacy (ability to read and write),
- Ability to communicate effectively without language or cognitive barriers,
- Voluntary participation confirmed by signed written informed consent.
Who cannot join
- History of communication disorders or neuromusculoskeletal diseases that impede assessment procedures,
- Headache frequency exceeding 15 days per month,
- Diagnosis of other primary or secondary headache types (e.g., cervicogenic headache, tension-type headache),
- Pregnancy,
- Diagnosis of fibromyalgia syndrome or myofascial pain syndrome,
- Diagnosis of systemic rheumatic diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus),
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- Diagnosis or presence of symptoms related to spinal disc disorders (e.g., disc herniation, disc prolapse),
- History of whiplash or similar cervical/head trauma,
- Diagnosis or presence of symptoms associated with temporomandibular joint dysfunction (TMD),
- Having received physical therapy within the last 3 months,
- Having undergone anesthetic nerve block procedures within the last 6 months,
- Receiving any prophylactic or interventional migraine therapy other than acute analgesics,
- Self-reported history or presence of malignancy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Multi-segmental Spinal Manual Therapy for Pain, Central Sensitization, and Sensorimotor Control in Women With Episodic Migraine: A Case Series.
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.
- Conditions
- Migraine Disorders
- Being tested
- Multi-Segmental Spinal Manual Therapy
- Keywords
- Episodic Migraine, Manual Therapy, Spinal Mobilization, Central Sensitization, Sensorimotor Control, Musculoskeletal Manipulations, Cutaneous Allodynia
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-Segmental Spinal Manual TherapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Spinal Mobilization Group | Experimental | 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. Receives: Procedure: Multi-Segmental Spinal Manual Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Immediately after completion of treatment at Week 2, and 1-month follow-up.
Secondary outcomes (3)
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).
Measured: 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."
Measured: 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).
Measured: Baseline, Immediately after completion of treatment at Week 2, and 1-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Borna Farhoomand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Borna Farhoomand, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07774286
- Sponsor's protocol ID
- E-60116787-020-838104
- Status last verified
- Aug 2026
- First submitted
- 16 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-segmental Spinal Manual Therapy for Pain, Central Sensitization, and Sensorimotor Control in Women With Episodic Migraine: A Case Series.
- ClinicalTrials.gov ID
- NCT07774286
- Acronym / sponsor ID
- E-60116787-020-838104
- Conditions
- Migraine Disorders
- Keywords
- Episodic Migraine, Manual Therapy, Spinal Mobilization, Central Sensitization, Sensorimotor Control, Musculoskeletal Manipulations, Cutaneous Allodynia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Borna FarhoomandUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal Mobilization Group | Experimental | Procedure: Multi-Segmental Spinal Manual TherapyParticipants 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Female patients aged 18-30 years,
- Diagnosis of episodic migraine established by a specialist neurologist,
- Headache frequency of <15 days per month,
- Pain intensity score of ≥40 mm on the Visual Analog Scale (VAS),
- Absence of any diagnosed psychiatric disorders,
Key exclusion criteria (13 listed)
- History of communication disorders or neuromusculoskeletal diseases that impede assessment procedures,
- Headache frequency exceeding 15 days per month,
- Diagnosis of other primary or secondary headache types (e.g., cervicogenic headache, tension-type headache),
- Pregnancy,
- Diagnosis of fibromyalgia syndrome or myofascial pain syndrome,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-Segmental Spinal Manual TherapyThe 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. | Procedure or surgery | Spinal Mobilization Group |
Primary outcome
Headache Intensity Assessed via Visual Analog Scale (VAS)
Time frame: Baseline, Immediately after completion of treatment at Week 2, and 1-month follow-up.
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.
3 secondary outcomes
Headache-Related Disability Grade Assessed via Migraine Disability Assessment (MIDAS) Questionnaire.
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).
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).
Time frame: Baseline, Immediately after completion of treatment at Week 2, and 1-month follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-Segmental Spinal Manual Therapy in people with Migraine Disorders, run by Borna Farhoomand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Borna FARHOOMAND, PT, MSc (05449033638, borna.farhoomand@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache Intensity Assessed via Visual Analog Scale (VAS) (time frame: Baseline, Immediately after completion of treatment at Week 2, and 1-month follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.