FibromyalgiaFMSNCT07839065
Thoracolumbar Fascia Thickness in Women With Fibromyalgia
An observational study of Fibromyalgia, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2026to 15 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Etlik City Hospital
Ankara, Ankara, 06500
AYSE BETUL ACAR, 05326685180
About this study
Official title: Ultrasonographic Evaluation of Thoracolumbar Fascia Thickness in Women With Fibromyalgia: A Prospective Cross-Sectional Study With Healthy Controls
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.
Read the detailed description
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.
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Thoracolumbar fascia, Fascia thickness, Ultrasonography, Chronic widespread pain
- Medical subject headings
- Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the single study visit
Secondary 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.
Measured: During the single study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start1 Sep 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damla Yürük, Diskapi Teaching and Research Hospital
- Investigators
- AYSE BETUL ACAR, Principal investigator, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07839065
- Sponsor's protocol ID
- FMS-TLF-2026
- Other IDs
- 2024-KAEK-40
- Acronym
- FMS
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Mirza Y, Sari F, Yilmaz PD, Kucuk A. Evaluation of abdominal and lumbar multifidus muscles thickness and relation to endurance, pain, fatigue and functional mobility in patients with Fibromyalgia syndrome: a case-control study. Rheumatol Int. 2025 Feb 21;45(3):56. doi: 10.1007/s00296-025-05813-7.
PubMed 39982517Meral HB, Rezvani A, Tolu S, Usen A, Dasdelen MF. Structural changes in the upper trapezius muscle of fibromyalgia patients identified by quantitative ultrasonography: a cross-sectional study. Rheumatol Int. 2025 Apr 22;45(5):115. doi: 10.1007/s00296-025-05871-x.
PubMed 40261374Langevin HM, Stevens-Tuttle D, Fox JR, Badger GJ, Bouffard NA, Krag MH, Wu J, Henry SM. Ultrasound evidence of altered lumbar connective tissue structure in human subjects with chronic low back pain. BMC Musculoskelet Disord. 2009 Dec 3;10:151. doi: 10.1186/1471-2474-10-151.
PubMed 19958536
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Evaluation of Thoracolumbar Fascia Thickness in Women With Fibromyalgia: A Prospective Cross-Sectional Study With Healthy Controls
- ClinicalTrials.gov ID
- NCT07839065
- Acronym / sponsor ID
- FMS / FMS-TLF-2026
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Thoracolumbar fascia, Fascia thickness, Ultrasonography, Chronic widespread pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 24 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Thoracolumbar Fascia Thickness
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.
1 secondary outcome
Pain Intensity Assessed by Visual Analog Scale
Time frame: During the single study visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Results publication: PubMed 39982517Mirza Y, Sari F, Yilmaz PD, Kucuk A. Evaluation of abdominal and lumbar multifidus muscles thickness and relation to endurance, pain, fatigue and functional mobility in patients with Fibromyalgia syndrome: a case-control study. Rheumatol Int. 2025 Feb 21;45(3):56. doi: 10.1007/s00296-025-05813-7.
- Results publication: PubMed 40261374Meral HB, Rezvani A, Tolu S, Usen A, Dasdelen MF. Structural changes in the upper trapezius muscle of fibromyalgia patients identified by quantitative ultrasonography: a cross-sectional study. Rheumatol Int. 2025 Apr 22;45(5):115. doi: 10.1007/s00296-025-05871-x.
- Results publication: PubMed 19958536Langevin HM, Stevens-Tuttle D, Fox JR, Badger GJ, Bouffard NA, Krag MH, Wu J, Henry SM. Ultrasound evidence of altered lumbar connective tissue structure in human subjects with chronic low back pain. BMC Musculoskelet Disord. 2009 Dec 3;10:151. doi: 10.1186/1471-2474-10-151.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AYSE BETUL ACAR principal investigator
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AYSE BETUL ACAR (+905326685180, betulbozann@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thoracolumbar Fascia Thickness (time frame: During the single study visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07839065, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.