Skip to main content
OpenTrials
Not yet recruiting

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 (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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

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 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    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).

  2. 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.

    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."

  3. 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.

    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).

Interested in participating?

Not yet recruiting

Trial opening soon.

Get Notified

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 25, 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.

Published trials that share one or more normalized conditions with this study.