Ankara Etlik City Hospital
Ankara, 06500, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07839065
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.
Interested in participating?
Request Info18 year–65 year
Female
Observational
Ankara, 06500, Turkey (Türkiye)
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: During the single study visit
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.
Interested in participating?
Request InfoDiskapi Teaching and Research Hospital
Other
Ultrasonographic Evaluation of Thoracolumbar Fascia Thickness in Women With Fibromyalgia: A Prospective Cross-Sectional Study With Healthy Controls
Acronym: FMS
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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