Tension-Type Headache and Masseter Thickness in Fibromyalgia

Completed

• Conditions: Fibromyalgia

• Registration Number: NCT06713278
• Lead Sponsor: Ankara City Hospital Bilkent

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.

Study Timeline

• Study Start: 2024-05-15
• Study First Submitted: 2024-11-24
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-01
• Primary Completion: 2024-12-02
• Study Completion: 2024-12-02
• Last Update Submitted: 2024-12-02
• Study First Posted: 2024-12-03
• Last Update Posted: 2024-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 94

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Masseter muscle thickness	1 day	Measurement of masseter muscle thickness by ultrasonography

Secondary Outcome Measures

Name	Time	Method
HIT-6 (Headache Impact Test-6)	1 day	HIT-6 (Headache Impact Test-6):The HIT-6 (Headache Impact Test-6) consists of 6 questions, each evaluated using a 5-point Likert scale. The scale assigns the following scores: 6 points for "never," 8 points for "rarely," 10 points for "sometimes," 11 points for "very often," and 13 points for "always." The total score ranges from 36 to 78. The severity of the headache's impact is categorized as follows: 60-78: Severe impact 56-59: Substantial impact 50-55: Moderate impact \<49: Little to no impact Higher scores indicate worse outcomes.
FIQ (Fibromyalgia Impact Questionnaire)	1 day	FIQ (Fibromyalgia Impact Questionnaire):The Fibromyalgia Impact Questionnaire (FIQ) is a validated and reliable tool in Turkish that measures the impact of fibromyalgia on daily life. It consists of 10 main items covering various aspects of daily life, including physical functionality, ability to perform tasks, sleep quality, emotional well-being, and pain. The total FIQ score is categorized as follows: 0-38: Mild impact 39-58: Moderate impact 59-100: Severe impact Higher scores indicate worse outcomes.
Fibromyalgia Total Score	1 day	The Fibromyalgia Total Score assesses the severity and impact of fibromyalgia symptoms. It is typically calculated as the sum of two components: the Widespread Pain Index (WPI) and the Symptom Severity Scale (SSS).; Calculation Widespread Pain Index (WPI):Evaluates the number of body regions experiencing pain, ranging from 0 to 19.; Symptom Severity Scale (SSS):Assesses the severity of fatigue, unrefreshed sleep, and cognitive difficulties, along with the presence of other somatic symptoms, ranging from 0 to 12.; Total Score:The Fibromyalgia Total Score ranges from 0 to 31. Higher scores indicate more severe symptoms and a greater impact of fibromyalgia. Higher scores indicate worse outcomes.; This score is used to aid in diagnosing fibromyalgia and evaluating its severity.
Widespread Pain Index (WPI)	1 day	The Widespread Pain Score (WPI) is a measure included in the 2016 ACR fibromyalgia diagnostic criteria. It consists of 19 body regions. Participants indicate the areas where they experience pain, receiving 1 point for each marked region. The WPI is scored on a scale of 0 to 19. Higher scores indicate worse outcomes.
Symptom Severity Scale (SSS)	1 day	The Symptom Severity Scale (SSS) is a measure included in the 2016 ACR fibromyalgia diagnostic criteria.; First Section: Evaluates fatigue, waking unrefreshed, and cognitive symptoms, scored as follows:0 (none), 1 (mild), 2 (moderate), 3 (severe).; Second Section: Assesses the presence of headaches, lower abdominal pain, and depression, scored as:0 (absent), 1 (present).; The total SSS score ranges from 0 to 12. Higher scores indicate worse outcomes.

Trial Locations

Locations (1)

Çorum Hitit University Erol Olçok Training and Research Hospital; 🇹🇷 Çorum, Turkey