Pericranial and General Sensitivity in Patients With Primary Headache
Enrolling by invitationNCT07514208
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 …
Study details
- Official title
- Pericranial and General Sensitivity in Patients With Primary Headache: a Multicenter Case-control Study
- Conditions
- Primary Headache Disorders
- Tension Headache
- Tension-type Headache
- Migraine
- Chronic Overlapping Pain Disorders
- Interventions
- Diagnostic test: Pericranial Tenderness Assessment
- Diagnostic test: Pressure Pain Threshold Assessment
- Diagnostic test: Temporomandibular Disorder Assessment
- Diagnostic test: Patient-Reported Outcome Assessment
- Diagnostic test: Cervical Function Assessment
- Diagnostic test: Multimodal Clinical Assessment
- Sponsor
- Universitat Internacional de Catalunya
- Start date
- 2026-03-31
- Primary completion
- 2027-06
- Sex
- All
- Age range
- from 18 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- Spain
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria Adults diagnosed with primary headache disorders, including migraine or tension-type headache, according to the International Classification of Headache Disorders third edition. Diagnosis confirmed by a headache specialist. Stable medical treatment for headache for at least six months prior to participation. Ability to understand and communicate in Spanish, English, or German. Ability to provide written informed consent. Exclusion Criteria Presence of secondary headache disorders or clinical suspicion of secondary headache based on screening criteria. Recent onset of undiagnosed headache or unilateral neck pain associated with neurological or neuropathic symptoms. Severe dermatological conditions or injuries affecting the head, neck, or intraoral region that could interfere with clinical examination. Recent fractures affecting the head or cervical region. Previous diagnosis of uncontrolled psychiatric disorders or neurodegenerative diseases. Pregnancy.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07514208