Thoracolumbar Fascia Thickness in Women With Fibromyalgia
ConditionFibromyalgia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-65
SponsorDiskapi Teaching and Research Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
The study population will consist of women aged 18-65 years. The fibromyalgia group will include women diagnosed with fibromyalgia according to the 2016 revised American College of Rheumatology criteria. The healthy control group will consist of women without fibromyalgia or chronic widespread pain. Healthy controls will be selected to be as comparable as possible to the fibromyalgia group in terms of age and body mass index. All participants will be recruited at Ankara Etlik City Hospital, Algology Clinic.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 2 trial groupsGroup A: Fibromyalgia Group
Group B: Healthy Control Group
Trial outcomes
Primary outcomes
1
Thoracolumbar Fascia Thickness
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.
Time frame
During the single study visitSecondary outcomes
1
Pain Intensity Assessed by Visual Analog Scale
Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.
Time frame
During the single study visitSponsors and contacts
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Source ClinicalTrials.gov