SpondyloarthropathyNCT06495866
Ultrasound Assessment of Entheseal Sites in Patients with Seronegative Spondyloarthropathy with or Without Fibromyalgia
An observational study of Spondyloarthropathy and Fibromyalgia, run by Sohag University at 1 site in Egypt.
Trial summary
Seronegative spondyloarthropathies are a family of joint disorders that classically include ankylosing spondylitis (AS), psoriatic arthritis (PsA), inflammatory bowel disease (IBD) associated arthritis, reactive arthritis (formerly Reiter syndrome; ReA), and undifferentiated SpA. Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Spondyloarthropathy, Fibromyalgia
- What is being tested?
- ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2024to Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Inclusion Criteria: * Patients fulfill the Assessment in Spondyloarthrits International Society (ASAS) classification criteria for Axial Spondyloarthritis. * Age above 18 years old. * Patient cooperative and can answer questions. * Patients who are able and willing to give written informed consent.
Who may be able to join
- Patients fulfill the Assessment in Spondyloarthrits International Society (ASAS) classification criteria for Axial Spondyloarthritis.
- Age above 18 years old.
- Patient cooperative and can answer questions.
- Patients who are able and willing to give written informed consent.
Who cannot join
- Other rheumatologic or collagen diseases.
- Age below 18 years and above 60 years.
- Uncooperative patients.
- Patient not able and willing to give written informed consent.
Trial locations and contacts
1 site in 1 country.
Ahmed R Al-Agamy, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University hospitals
Sohag, Sohag Governorate
Magdy M Amin, Professor, portal@med.sohag.edu.eg
About this study
Seronegative spondyloarthropathies are a family of joint disorders that classically include ankylosing spondylitis (AS), psoriatic arthritis (PsA), inflammatory bowel disease (IBD) associated arthritis, reactive arthritis (formerly Reiter syndrome; ReA), and undifferentiated SpA. Enthesitis, or inflammation of the sites where the tendons or ligaments insert into the bone, is a key pathological finding in SpA . It is considered the hallmark and characteristic feature of spondyloarthritis (SpA). Entheses could be classified as fibrous entheses and fibrocartilaginous entheses. Regional structural damage, such as tendon injuries and bone erosions, are frequently caused by persistent enthesitis. The healing process that follows may result in the emergence of enthesophytes and, eventually, functional impairment of related anatomic structures. Imaging modalities for evaluating entheseal lesions include conventional radiology, bone scintigraphy, magnetic resonance imaging (MRI) and power Doppler (PD) ultrasound (US). US has its own unique advantage in the diagnosis of enthesitis in AS; it uses a high-frequency or ultra-high-frequency probe that effectively visualizes the internal structure of the tendon and is recognized as the gold standard for tendon involvement.
It is superior to clinical examination in the detection of peripheral enthesitis.
Manifestations of tendon enthesitis in SpA on US include a thickened tendon, hypoechoicity, local calcification and bony erosion. Abnormal blood flow in tendon entheseal sites can be detected by Power Doppler US. Fibromyalgia (FM) is a syndrome characterized by chronic musculoskeletal pain. The main symptoms of which are muscle stiffness, joint stiffness, insomnia, fatigue, mood disorders, cognitive dysfunction, anxiety, depression, general sensitivity and the inability to carry out normal daily activities [8, 9]. It can also be associated with specific diseases, such as infections, diabetes, rheumatic diseases and psychiatric or neurological disorders. Smythe and Moldofsky later developed the name "fibromyalgia" after identifying "pain points," which are areas of severe tenderness. These points are defined as areas of hyperalgesia/allodynia when a pressure of about 4 kg causes pain.
- Conditions
- Spondyloarthropathy, Fibromyalgia
- Being tested
- ultrasound
- Keywords
- Spondyloarthropathy, Fibromyalgia, Enthesitis, Ultrasound
- Medical subject headings
- Spondylarthropathies, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundRadiation
Ultrasound finding of entheseal sites of upper \& lower limbs of all groups and scoring according to enthesitis scoring system
| Study group | Role | What they receive |
|---|---|---|
| cases of seronegative spondyloarthropathy with fibromyalgia | cases already diagnosed as seronegative spondyloarthropathy by application of ASAS classificatin criteria for axial SpA and have concomitant fibromyalgia according to 2016 ACR criteria. Receives: Radiation: ultrasound | |
| cases of seronegative spondyloarthropathy without fibromyalgia | cases already diagnosed as seronegative spondyloarthropathy by application of ASAS classificatin criteria for axial SpA and do not match with 2016 ACR criteria for fibromyalgia. Receives: Radiation: ultrasound | |
| controls | control individuals will be matched for sex, age, and level of schooling without history of inflammatory joint disorders or any systemic active disease. Receives: Radiation: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of ultrasound detected enthesitis among both groups and controls
Comparison of ultrasound detected enthesitis among patients with spondyloarthropathy with secondary fibromyalgia and those with isolated spondyloarthropathy without fibromyalgia and among controls. Cases of Spondyloarthropathy will be already diagnosed using ASAS classification criteria.
All patients will be subjected to the following:
- Full medical history from the patients including Demographic data (Age Sex - Marital status - Occupation - Residence), duration of disease - The treatments that patients receive.
- Full clinical examination and assessment including: (a) General examination and Complete rheumatological examination. (b) ASDAS. (c) Application of 2016 ACR criteria for fibromyalgia on all SpA patients to detect cases with secondary fibromyalgia.
- Laboratory investigations: (complete blood picture, erythrocyte sedimentation rate, C- reactive protein).
- Ultrasound finding of entheseal sites of upper \& lower limbs.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start10 Aug 2024
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SpondyloarthropathyStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aalaa Ahmed El-Sayed, Sohag University
- Investigators
- Ahmed R Al-Agamy, MD, Study chair, Sohag UniversityOla M Mohammed, MD, Study director, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495866
- Sponsor's protocol ID
- Soh-Med-24-06-19MS
- Status last verified
- Jul 2024
- First submitted
- 3 Jul 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Healy PJ, Helliwell PS. Classification of the spondyloarthropathies. Curr Opin Rheumatol. 2005 Jul;17(4):395-9. doi: 10.1097/01.bor.0000167753.01168.bd.
PubMed 15956834Kehl AS, Corr M, Weisman MH. Review: Enthesitis: New Insights Into Pathogenesis, Diagnostic Modalities, and Treatment. Arthritis Rheumatol. 2016 Feb;68(2):312-22. doi: 10.1002/art.39458. No abstract available.
PubMed 26473401Dougados M, van der Linden S, Juhlin R, Huitfeldt B, Amor B, Calin A, Cats A, Dijkmans B, Olivieri I, Pasero G, et al. The European Spondylarthropathy Study Group preliminary criteria for the classification of spondylarthropathy. Arthritis Rheum. 1991 Oct;34(10):1218-27. doi: 10.1002/art.1780341003.
PubMed 1930310D'Agostino MA, Terslev L. Imaging Evaluation of the Entheses: Ultrasonography, MRI, and Scoring of Evaluation. Rheum Dis Clin North Am. 2016 Nov;42(4):679-693. doi: 10.1016/j.rdc.2016.07.012. Epub 2016 Sep 7.
PubMed 27742021
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Assessment of Entheseal Sites in Patients with Seronegative Spondyloarthropathy with or Without Fibromyalgia
- ClinicalTrials.gov ID
- NCT06495866
- Acronym / sponsor ID
- Soh-Med-24-06-19MS
- Conditions
- Spondyloarthropathy, Fibromyalgia
- Keywords
- Spondyloarthropathy, Fibromyalgia, Enthesitis, Ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 10 Aug 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 11 Jul 2024 (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.
Seronegative spondyloarthropathies are a family of joint disorders that classically include ankylosing spondylitis (AS), psoriatic arthritis (PsA), inflammatory bowel disease (IBD) associated arthritis, reactive arthritis (formerly Reiter syndrome; ReA), and undifferentiated SpA. Enthesitis, or inflammation of the sites where the tendons or ligaments insert into the bone, is a key pathological finding in SpA . It is considered the hallmark and characteristic feature of spondyloarthritis (SpA). Entheses could be classified as fibrous entheses and fibrocartilaginous entheses. Regional structural damage, such as tendon injuries and bone erosions, are frequently caused by persistent enthesitis. The healing process that follows may result in the emergence of enthesophytes and, eventually, functional impairment of related anatomic structures. Imaging modalities for evaluating entheseal lesions include conventional radiology, bone scintigraphy, magnetic resonance imaging (MRI) and power Doppler (PD) ultrasound (US). US has its own unique advantage in the diagnosis of enthesitis in AS; it uses a high-frequency or ultra-high-frequency probe that effectively visualizes the internal structure of the tendon and is recognized as the gold standard for tendon involvement.
It is superior to clinical examination in the detection of peripheral enthesitis.
Manifestations of tendon enthesitis in SpA on US include a thickened tendon, hypoechoicity, local calcification and bony erosion. Abnormal blood flow in tendon entheseal sites can be detected by Power Doppler US. Fibromyalgia (FM) is a syndrome characterized by chronic musculoskeletal pain. The main symptoms of which are muscle stiffness, joint stiffness, insomnia, fatigue, mood disorders, cognitive dysfunction, anxiety, depression, general sensitivity and the inability to carry out normal daily activities [8, 9]. It can also be associated with specific diseases, such as infections, diabetes, rheumatic diseases and psychiatric or neurological disorders. Smythe and Moldofsky later developed the name "fibromyalgia" after identifying "pain points," which are areas of severe tenderness. These points are defined as areas of hyperalgesia/allodynia when a pressure of about 4 kg causes pain.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cases of seronegative spondyloarthropathy with fibromyalgia | – | Radiation: ultrasoundcases already diagnosed as seronegative spondyloarthropathy by application of ASAS classificatin criteria for axial SpA and have concomitant fibromyalgia according to 2016 ACR criteria. |
| cases of seronegative spondyloarthropathy without fibromyalgia | – | Radiation: ultrasoundcases already diagnosed as seronegative spondyloarthropathy by application of ASAS classificatin criteria for axial SpA and do not match with 2016 ACR criteria for fibromyalgia. |
| controls | – | Radiation: ultrasoundcontrol individuals will be matched for sex, age, and level of schooling without history of inflammatory joint disorders or any systemic active disease. |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Inclusion Criteria: * Patients fulfill the Assessment in Spondyloarthrits International Society (ASAS) classification criteria for Axial Spondyloarthritis. * Age above 18 years old. * Patient cooperative and can answer questions. * Patients who are able and willing to give written informed consent.
Key inclusion criteria (4 listed)
- Patients fulfill the Assessment in Spondyloarthrits International Society (ASAS) classification criteria for Axial Spondyloarthritis.
- Age above 18 years old.
- Patient cooperative and can answer questions.
- Patients who are able and willing to give written informed consent.
Key exclusion criteria (4 listed)
- Other rheumatologic or collagen diseases.
- Age below 18 years and above 60 years.
- Uncooperative patients.
- Patient not able and willing to give written 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasoundUltrasound finding of entheseal sites of upper \& lower limbs of all groups and scoring according to enthesitis scoring system | Radiation | cases of seronegative spondyloarthropathy with fibromyalgia, cases of seronegative spondyloarthropathy without fibromyalgia, controls |
Primary outcome
Comparison of ultrasound detected enthesitis among both groups and controls
Time frame: 12 months
Comparison of ultrasound detected enthesitis among patients with spondyloarthropathy with secondary fibromyalgia and those with isolated spondyloarthropathy without fibromyalgia and among controls. Cases of Spondyloarthropathy will be already diagnosed using ASAS classification criteria. All patients will be subjected to the following: 1. Full medical history from the patients including Demographic data (Age Sex - Marital status - Occupation - Residence), duration of disease - The treatments that patients receive. 2. Full clinical examination and assessment including: (a) General examination and Complete rheumatological examination. (b) ASDAS. (c) Application of 2016 ACR criteria for fibromyalgia on all SpA patients to detect cases with secondary fibromyalgia. 3. Laboratory investigations: (complete blood picture, erythrocyte sedimentation rate, C- reactive protein). 4. Ultrasound finding of entheseal sites of upper \& lower limbs.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Background: PubMed 15956834Healy PJ, Helliwell PS. Classification of the spondyloarthropathies. Curr Opin Rheumatol. 2005 Jul;17(4):395-9. doi: 10.1097/01.bor.0000167753.01168.bd.
- Background: PubMed 26473401Kehl AS, Corr M, Weisman MH. Review: Enthesitis: New Insights Into Pathogenesis, Diagnostic Modalities, and Treatment. Arthritis Rheumatol. 2016 Feb;68(2):312-22. doi: 10.1002/art.39458. No abstract available.
- Background: PubMed 1930310Dougados M, van der Linden S, Juhlin R, Huitfeldt B, Amor B, Calin A, Cats A, Dijkmans B, Olivieri I, Pasero G, et al. The European Spondylarthropathy Study Group preliminary criteria for the classification of spondylarthropathy. Arthritis Rheum. 1991 Oct;34(10):1218-27. doi: 10.1002/art.1780341003.
- Background: PubMed 27742021D'Agostino MA, Terslev L. Imaging Evaluation of the Entheses: Ultrasonography, MRI, and Scoring of Evaluation. Rheum Dis Clin North Am. 2016 Nov;42(4):679-693. doi: 10.1016/j.rdc.2016.07.012. Epub 2016 Sep 7.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Ahmed R Al-Agamy, MD contact
Ahmed R Al-Agamy, MD study chair
Sohag University
Ola M Mohammed, MD study director
Sohag University
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 Spondyloarthropathy and Fibromyalgia, run by Sohag University at 1 site in Egypt.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 29 Nov 2024. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aalaa A El-Sayed, Master (01155442188, alaa_ahmed_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of ultrasound detected enthesitis among both groups and controls (time frame: 12 months). 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 NCT06495866, which also lists 4 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 29 Nov 2024.