Multi-Segmental Spinal Manual Therapy in Women With Episodic Migraine

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-30
SponsorBorna Farhoomand

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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),

Disqualifiers

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,

Trial design

Design model

Single group

Treatments tested in this trial

  • Multi-Segmental Spinal Manual Therapy

    Procedure/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.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Spinal Mobilization GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

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.
2

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.
3

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.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Borna Farhoomand

Lead sponsor

Pamukkale University

Sponsor institution

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