Ultrasound Assessment of Entheseal Sites in Patients with Seronegative Spondyloarthropathy with or Without Fibromyalgia

NCT06495866 | Recruiting

• 1 other identifier: Soh-Med-24-06-19MS
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Spondyloarthropathy; Fibromyalgia; Enthesitis; Ultrasound

Outcome Measures

Primary Outcomes (1)

• 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: 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.

  12 months

Study Arms (3)

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.

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.

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.

Radiation: ultrasound

Interventions

ultrasound RADIATION

Ultrasound finding of entheseal sites of upper \& lower limbs of all groups and scoring according to enthesitis scoring system

cases of seronegative spondyloarthropathy with fibromyalgia; cases of seronegative spondyloarthropathy without fibromyalgia; controls

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University hospitals

Sohag, Sohag Governorate, Egypt

RECRUITING

Related Publications (4)

• 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.

  PMID: 15956834 BACKGROUND

• Kehl 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.

  PMID: 26473401 BACKGROUND

• Dougados 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.

  PMID: 1930310 BACKGROUND

• D'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.

  PMID: 27742021 BACKGROUND

MeSH Terms

Conditions

Spondylarthropathies; Fibromyalgia

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Muscular Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Ahmed R Al-Agamy, MD

  Sohag University

  STUDY CHAIR

• Ola M Mohammed, MD

  Sohag University

  STUDY DIRECTOR

Central Study Contacts

Aalaa A El-Sayed, Master

CONTACT

01155442188; alaa_ahmed_post@med.sohag.edu.eg

Ahmed R Al-Agamy, MD

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident of Physical medicine, Rheumatology and Rehabilitation Department

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 11, 2024
• Study Start: August 10, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: November 29, 2024

Record last verified: 2024-07

Locations

EG (1)