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NCT Number: NCT07774286

Multi-Segmental Spinal Manual Therapy in Women With Episodic Migraine

The purpose of this study is to evaluate the clinical effects of multi-segmental spinal manual therapy on pain intensity, central sensitization, and sensorimotor control in women diagnosed with episodic migraine.

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 episodic migraine.

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Key information

Conditions

Migraine Disorders Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Nervous System Diseases

Age range

18 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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),
  • 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.

Treatment and study plan

Multi-Segmental Spinal Manual Therapy

Procedure

The intervention protocol consists of 10 individual sessions delivered over 2 consecutive weeks (5 sessions per week, approximately 30 to 45 minutes per session).

The treatment includes two primary components:

  • Multi-segmental Spinal Joint Mobilizations: Passive joint mobilization techniques (specifically Mulligan Concept techniques, such as Mobilization with Movement [MWM] and Natural Glides) applied to the cervical, thoracic, lumbar, and sacral regions based on baseline physical examination findings. High-velocity low-amplitude (HVLA) thrust manipulations are not performed.
  • Cervical Soft Tissue Mobilization: Soft tissue mobilization and myofascial techniques targeted specifically to the cervical and suboccipital musculature.

All procedures are administered by a licensed physical therapist in a standardized clinical setting.

Primary outcomes

  1. Change in Pain Intensity

    Time frame: Baseline, Immediately after completion of treatment (Week 2), and 1-month follow-up.

    Headache intensity assessed using a 10-cm Visual Analog Scale (VAS) anchored at 0 ("no pain") and 10 ("severe, unbearable pain").Higher scores indicate greater pain severity

Secondary outcomes

  1. Change in Migraine Disability Assessment (MIDAS) Score

    Time frame: Baseline, Immediately after completion of treatment (Week 2), and 1-month follow-up

    Assessed using the 5-item MIDAS questionnaire to quantify headache-related disability and lost productivity across work, school, and household activities. Scores are categorized into four disability grades ranging from Grade I (little/no disability) to Grade IV (severe disability).

  2. Change in Allodynia Symptom Checklist (ASC-12) Score

    Time frame: Baseline, Immediately after completion of treatment (Week 2), and 1-month follow-up.

    Cutaneous allodynia severity assessed using the 12-item Allodynia Symptom Checklist (ASC-12), covering static, dynamic, and thermal symptoms. Total scores range from 0 to 24, where higher scores indicate greater cutaneous allodynia severity.

  3. Change in Sensory-Motor Dysfunction Questionnaire (SMD-Q) Score.

    Time frame: Baseline, Immediately after completion of treatment (Week 2), and 1-month follow-up.

    Evaluated using the 12-item Sensory-Motor Dysfunction Questionnaire (SMD-Q) to measure balance, proprioception, motor performance, and multimodal processing discrepancies . Total scores range from 0 to 36, with higher scores representing a more pronounced level of sensorimotor dysfunction.

Study contacts

Contact information is provided by the study sponsor or research team.

Borna FARHOOMAND, PT, MSc

CONTACT

[email protected]

05449033638

Sponsors and collaborators

Lead sponsor

Borna Farhoomand

Other

Registry information

Official study title

Multi-segmental Spinal Manual Therapy for Pain, Central Sensitization, and Sensorimotor Control in Women With Episodic Migraine: A Case Series.

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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