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临床试验/NCT06713278
NCT06713278已完成不适用

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

Ankara City Hospital Bilkent1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2024年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
94
试验地点
1
主要终点
Masseter muscle thickness

研究概览

简要总结

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?

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Masseter muscle thickness

时间窗: 1 day

Measurement of masseter muscle thickness by ultrasonography

次要结局

  • HIT-6 (Headache Impact Test-6)(1 day)
  • FIQ (Fibromyalgia Impact Questionnaire)(1 day)
  • Fibromyalgia Total Score(1 day)
  • Widespread Pain Index (WPI)(1 day)
  • Symptom Severity Scale (SSS)(1 day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Handan Elif Nur BAYRAKTAR

Specialist

Erol Olcok Corum Training and Research Hospital

研究点 (1)

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