Ultrasonographic Evaluation of Thoracolumbar Fascia Thickness in Women With Fibromyalgia: A Prospective Cross-Sectional Study With Healthy Controls
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Thoracolumbar Fascia Thickness
研究概览
简要总结
This prospective cross-sectional observational study aims to compare thoracolumbar fascia thickness between women with fibromyalgia and healthy female controls using ultrasonography. Thoracolumbar fascia thickness will be measured bilaterally at the L2-L3 and L4-L5 levels. Secondary analyses will evaluate the relationships between thoracolumbar fascia thickness and pain intensity, fibromyalgia-related functional impact, widespread pain, and symptom severity in participants with fibromyalgia.
详细描述
This prospective, observational, controlled, cross-sectional study will evaluate thoracolumbar fascia thickness in women with fibromyalgia and compare the findings with those of healthy female controls. The study will include women aged 18-65 years and will be conducted at Ankara Etlik City Hospital, Algology Clinic. No therapeutic intervention, medication, injection, or surgical procedure will be administered as part of the study.
A total of 60 participants are planned to be enrolled, including 30 women with fibromyalgia and 30 healthy female controls. Participants in the fibromyalgia group will meet the 2016 revised American College of Rheumatology criteria for fibromyalgia. Healthy controls will have no history of fibromyalgia or chronic widespread pain and will be selected to be as comparable as possible to the fibromyalgia group with respect to age and body mass index.
Thoracolumbar fascia thickness will be assessed using ultrasonography with participants in the prone position and the lumbar spine in a neutral position. Measurements will be obtained bilaterally at the L2-L3 and L4-L5 interspinous levels, 2 cm lateral to the midline. Four measurement sites will therefore be evaluated for each participant: right and left at L2-L3 and right and left at L4-L5. Measurements will be recorded separately for each side and level, and bilateral mean values will also be calculated.
In the fibromyalgia group, clinical assessments will include pain intensity measured with the Visual Analog Scale (VAS), the Revised Fibromyalgia Impact Questionnaire (FIQ-R), the Widespread Pain Index (WPI), and the Symptom Severity Scale (SSS). The relationships between thoracolumbar fascia thickness and these clinical measures will be evaluated. WPI and SSS assessments will also be used in the healthy control group to confirm the absence of clinically relevant widespread pain or fibromyalgia-related symptoms.
All study assessments will be completed during a single visit, and no longitudinal follow-up is planned.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- •Female sex
- •Age between 18 and 65 years
- •For the fibromyalgia group, diagnosis of fibromyalgia according to the 2016 revised American College of Rheumatology criteria
- •For the healthy control group, absence of fibromyalgia or chronic widespread pain
- •Willingness to participate and provision of written informed consent
排除标准
- •Pregnancy
- •Previous lumbar surgery or severe spinal deformity
- •Active infection, malignancy, or systemic inflammatory disease
- •History of trauma or surgery, or presence of a skin lesion at the ultrasonographic measurement site
- •Inability to complete the study assessments or provide informed consent
研究组 & 干预措施
Fibromyalgia Group
Women aged 18-65 years with fibromyalgia who meet the 2016 revised American College of Rheumatology criteria. Thoracolumbar fascia thickness will be assessed by ultrasonography at the L2-L3 and L4-L5 levels.
Healthy Control Group
Healthy women aged 18-65 years without fibromyalgia or chronic widespread pain. Thoracolumbar fascia thickness will be assessed using the same ultrasonographic protocol as in the fibromyalgia group.
结局指标
主要结局
Thoracolumbar Fascia Thickness
时间窗: During the single study visit
Thoracolumbar fascia thickness will be measured by ultrasonography bilaterally at the L2-L3 and L4-L5 interspinous levels, 2 cm lateral to the midline. Measurements will be recorded separately for the right and left sides at each level, and bilateral mean thickness values will also be calculated. Thoracolumbar fascia thickness will be compared between women with fibromyalgia and healthy female controls.
次要结局
- Pain Intensity Assessed by Visual Analog Scale(During the single study visit)
研究者
Damla Yürük
Pain Medicine Specialist
Diskapi Teaching and Research Hospital