An observational study in Fibromyalgia, sponsored by Diskapi Teaching and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Diskapi Teaching and Research Hospital · Observational
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.
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.
1,243 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.
This study's planned enrollment of 60 is below the median of 100 across 279 observational studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Diskapi Teaching and Research Hospital is the lead sponsor of 106 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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.
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 visit
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 visit
Plan to share: No — Individual participant data will not be shared with other researchers. Study data will be stored securely and will be accessible only to the research team. Results will be reported in aggregate form without information that could identify individual participants.
Started Sep 2026 (actual). Primary completion is estimated for Feb 2027, 5 months after the start.
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