Clinical trial NCT06713278: Tension-Type Headache and Masseter Thickness in Fibromyalgia
Official title: Association Between Tension-Type Headache and Masseter Muscle Thickness in Women with Fibromyalgia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibromyalgia
Keywords: tension type headache
masseter muscle
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-12-03
Enrollment: 94
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: female 18-65 years

Brief summary: This study aims to investigate the relationship between tension-type headaches and masseter muscle thickness in women with fibromyalgia syndrome (FMS) and to explore the potential for new therapeutic approaches in the treatment of both headaches and FMS. Additionally, the study seeks to evaluate the impact of headaches on the quality of life in individuals with FMS.

Does tension-type headache associate with increased masseter muscle thickness in women with fibromyalgia syndrome (FMS)? Does tension-type headache negatively impact the quality of life in women with FMS?

Detailed description: Fibromyalgia syndrome (FMS) is a chronic condition characterized by widespread musculoskeletal pain, fatigue, cognitive dysfunction, and tenderness, affecting approximately 5% of the global population, predominantly women. Central sensitization plays a key role in its pathophysiology. Tension-type headaches, the most common in FMS (59.01%), are associated with pericranial muscle sensitivity, anxiety, and reduced quality of life. Increased masseter muscle activity has been observed in tension-type headaches, but its relationship with FMS remains unexplored.

Eligibility criteria: Inclusion Criteria:

* Women aged 18-65 years.
* Diagnosed with fibromyalgia syndrome (FMS) according to the 2016 American College of Rheumatology (ACR) diagnostic criteria.
* At least one year since the FMS diagnosis.
* Chronic tension-type headache lasting for at least six months.
* Diagnosed with tension-type headache by a neurologist based on the International Classification of Headache Disorders (ICHD-3) criteria.

Exclusion Criteria:

* Patients with neurological or psychiatric disorders.
* Patients using medications related to the central nervous system.
* Those with temporomandibular dysfunction.
* Patients with rheumatologic diseases.
* Individuals undergoing dental treatment or using dental prostheses.
* Those with facial tumors or a history of facial surgery.
* Pregnant women.

Primary outcomes:
measure: Masseter muscle thickness
timeFrame: 1 day
Secondary outcomes:
measure: HIT-6 (Headache Impact Test-6)
timeFrame: 1 day
measure: FIQ (Fibromyalgia Impact Questionnaire)
timeFrame: 1 day
measure: Fibromyalgia Total Score
timeFrame: 1 day
measure: Widespread Pain Index (WPI)
timeFrame: 1 day
measure: Symptom Severity Scale (SSS)
timeFrame: 1 day
Other outcomes:
Locations:
city: Çorum
country: Turkey
facility: Çorum Hitit University Erol Olçok Training and Research Hospital
Study officials:
References:
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