Pericranial and General Sensitivity in Patients With Primary Headache

Sponsor
Universitat Internacional de Catalunya
Study ID
NCT07514208
Status
Enrolling By Invitation

Conditions

  • Chronic Overlapping Pain Disorders
  • Migraine
  • Primary Headache Disorders
  • Tension Headache
  • Tension-type Headache

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Pericranial Tenderness Assessment — DIAGNOSTIC_TEST
    Pericranial tenderness will be assessed using the Total Tenderness Score, a standardized clinical examination based on manual palpation of pericranial and cervical muscles. Bilateral palpation will be performed on eight pairs of muscle bodies and insertions including the masseter, temporalis, frontal muscle, coronoid process, upper trapezius, sternocleidomastoid, suboccipital muscles, and mastoid process. Palpation will be applied with approximately 1 kg of pressure using the second and third fingertips rotated for four to five seconds. Participant responses will be rated using a four point scale ranging from 0 (no tenderness) to 3 (severe tenderness with withdrawal or pronounced facial reaction). The sum of all responses will generate the Total Tenderness Score, with a maximum possible score of 48. This assessment is commonly used to quantify pericranial muscle tenderness in patients with headache and temporomandibular disorders.
  • Pressure Pain Threshold Assessment — DIAGNOSTIC_TEST
    Pressure pain thresholds will be assessed using a handheld digital algometer equipped with a 1 cm² probe. The probe will be positioned perpendicular to the skin at predefined extra trigeminal anatomical sites including the tibialis anterior muscle, the radial carpal extensor region at the dorsal wrist joint line, and the interspinous space between L5 and S1. Pressure will be progressively applied at a constant rate following visual guidance provided by the device interface. Participants will be instructed to indicate the moment when the sensation changes from pressure to pain. Three measurements will be obtained at each anatomical site with a resting interval between assessments. The mean value of the repeated measurements will be recorded and used to quantify generalized mechanical pain sensitivity.
  • Temporomandibular Disorder Assessment — DIAGNOSTIC_TEST
    Pain related temporomandibular disorders will be assessed using the standardized Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) clinical protocol. The examination includes structured assessment of temporomandibular joint pain, masticatory muscle pain, mandibular movement, joint sounds, and pain during functional movements or palpation. Based on the DC/TMD diagnostic algorithms, participants will be classified into pain related temporomandibular disorder categories including arthralgia, myalgia, combined myalgia and arthralgia, or headache attributed to temporomandibular disorder. The examination will be performed by trained clinicians following the validated DC/TMD protocol.
  • Patient-Reported Outcome Assessment — DIAGNOSTIC_TEST
    Participants will complete standardized self-reported questionnaires to assess pain related symptoms and associated health conditions. These will include the Central Sensitization Inventory to evaluate symptoms associated with central sensitization, the Brief Pain Inventory Short Form to assess pain intensity and pain related interference with daily activities, and a body pain drawing to document the distribution of pain. Additional questions will collect information on the presence and duration of physician-diagnosed chronic overlapping pain conditions. The questionnaires will be administered through a secure electronic data collection platform prior to or during the clinical assessment.
  • Cervical Function Assessment — DIAGNOSTIC_TEST
    Cervical function will be assessed using the NeckCare system, a wearable sensor-based platform designed to measure cervical spine kinematics and sensorimotor control. The system uses a lightweight head-mounted sensor connected to a computer interface that records cervical movement in real time. Active cervical range of motion will be measured for flexion, extension, right and left rotation, and right and left lateral flexion. Cervical proprioception will be evaluated using the Joint Position Error test, in which participants attempt to reposition the head to a neutral position without visual feedback after performing active cervical movements. Sensorimotor control will also be assessed using the Butterfly Test, which requires participants to follow a moving visual target with head movements while the system quantifies movement accuracy, coordination, and smoothness.
  • Multimodal Clinical Assessment — DIAGNOSTIC_TEST
    Participants will undergo a standardized multimodal clinical assessment designed to characterize pain sensitivity and related clinical variables. The assessment will include evaluation of pericranial muscle tenderness using the Total Tenderness Score, measurement of extra trigeminal pressure pain thresholds with digital algometry, and clinical examination for temporomandibular disorders using the Diagnostic Criteria for Temporomandibular Disorders protocol. Participants will also complete validated patient reported outcome measures assessing central sensitization symptoms, pain intensity, pain related interference, and distribution of pain. In addition, cervical spine function will be evaluated through objective measurement of cervical range of motion, proprioception, sensorimotor control, and cervical flexor muscle strength and endurance using wearable sensor technology and digital dynamometry. This integrated evaluation provides a comprehensive characterization of local and generaliz

Study Details

Primary headaches such as migraine and tension type headache are among the most common neurological disorders and frequently cause significant disability and reduced quality of life. Increasing evidence suggests that these headaches may share biological mechanisms with temporomandibular disorders, a group of conditions affecting the jaw muscles and temporomandibular joint. Both conditions are also often associated with other chronic pain disorders, suggesting that altered pain processing and sensitization of the nervous system may play an important role in their development. Despite these observations, few studies have simultaneously evaluated local muscle tenderness around the head and neck, generalized pain sensitivity in other parts of the body, and the presence of additional chronic pain conditions in patients with primary headaches. Understanding how these factors interact may help clarify why some patients develop more severe or persistent headache disorders and may improve future diagnostic and treatment strategies. The aim of this multicenter observational study is to compare patients with primary headaches to healthy individuals without headaches. The study will assess sensitivity of muscles around the head and neck, general pain sensitivity at distant body sites, the presence of temporomandibular disorders, and the number of other chronic pain conditions. Participants will also complete questionnaires about pain symptoms and related health conditions. Participants will undergo a clinical examination performed by trained clinicians, including manual assessment of tenderness in head and neck muscles and measurement of pressure pain thresholds using a handheld device. Additional evaluations will include standardized questionnaires about pain intensity, pain distribution, and symptoms related to central sensitization. Cervical motor and sensorimotor function will also be evaluated using a wearable sensor system. By comparing individuals with primary headaches and healthy controls, the study aims to better understand the relationship between headache disorders, jaw related pain conditions, and general pain sensitivity. The results may contribute to improved clinical assessment and a more comprehensive understanding of the mechanisms underlying headache and related pain disorders.

Key Dates

First listed
Apr 7, 2026
Start date
Mar 31, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
120 participants (estimated)

Arms

  • Arm: Primary Headache
    Participants diagnosed with primary headache disorders according to the International Classification of Headache Disorders third edition. Diagnosis will be confirmed by a headache specialist. Participants may include individuals with migraine or tension type headache and will undergo standardized clinical assessment including evaluation of pericranial tenderness, pressure pain thresholds, temporomandibular disorders, and pain related questionnaires.
  • Arm: Healthy subjects
    Healthy volunteers without clinically relevant headache after screening using a questionnaire based on the International Classification of Headache Disorders criteria. Participants who meet criteria for possible headache disorders will be excluded or referred for medical evaluation. Healthy controls will undergo the same clinical assessments as the case group to allow comparison of pain sensitivity and related clinical variables.

Primary Outcome Measure

Total Pericranial Tenderness Score [ Time Frame: Baseline assessment during the study visit. ]

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