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NCT Number: NCT06713278

Tension-Type Headache and Masseter Thickness in Fibromyalgia

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?

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Key information

Conditions

Fibromyalgia Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases Tension-Type Headache

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Çorum Hitit University Erol Olçok Training and Research Hospital

Çorum, 19040, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

masseter muscle thickness measurement

Other

masseter muscle thickness measurement with ultrasonography

Scales

Other

headache impact scale (HIT-6) Short SF-36 fibromyalgia total score widespread pain index symptom severity scale fibromyalgia impact questionnaire (FIQ)

Primary outcomes

  1. Masseter muscle thickness

    Time frame: 1 day

    Measurement of masseter muscle thickness by ultrasonography

Secondary outcomes

  1. HIT-6 (Headache Impact Test-6)

    Time frame: 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.

  2. FIQ (Fibromyalgia Impact Questionnaire)

    Time frame: 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.

  3. Fibromyalgia Total Score

    Time frame: 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.

  4. Widespread Pain Index (WPI)

    Time frame: 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.

  5. Symptom Severity Scale (SSS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Association Between Tension-Type Headache and Masseter Muscle Thickness in Women With Fibromyalgia

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 3, 2024
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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