Quantitative Ultrasound of the Enthesis in Fibromyalgia and Psoriatic Arthritis

Study Purpose

This prospective, cross-sectional, observational study will include subjects with fibromyalgia (FM), psoriatic arthritis (PsA) and asymptomatic controls. Participants will undergo a research ultrasound (US) exam of the enthesis of the Achilles' tendon, the medial collateral ligament at the femoral epicondyle and the common extensor tendon at lateral epicondyle of the elbow in resting conditions. The research US exam will consist of shear wave elastography (SWE) and radiofrequency (RF) data acquisitions. SWE technology will allow quantification of the shear wave speed (SWS) reporting the elastic stiffness of the tissues under investigation. RF data will be used to estimate quantitative ultrasound (QUS) parameters characterizing the mean intensity μ (akin to B-mode echogenicity), acoustic inhomogeneity (1/alpha), and structural spatial organization of echoes (κ) in the tissue.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 60 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria Male and female subjects of all races and ethnic backgrounds aged between 18

  • - 60 years, able to provide informed consent and willing not to engage in sports activities for two days before the ultrasound (US) evaluation, will be considered eligible for this study.
Subjects with fibromyalgia:
  • - The diagnosis of fibromyalgia is based on the 2011 ACR criteria and confirmed by a pain medicine physician working at a tertiary care academic center (CHUM) having experience with patients with fibromyalgia and other chronic pain syndromes.
  • - Fibromyalgia is the primary reason for the patient's symptoms, without any other comorbid condition that could fully account for the symptoms of pain.
  • - No skin condition (psoriasis, eczema and others) requiring regular topical treatment.
Subjects with psoriatic arthritis:
  • - Presenting with psoriatic arthritis.
  • - The diagnosis of psoriatic arthritis will be based on the ClASsification for Psoriatic Arthritis (CASPAR) criteria and established by a rheumatologist working at a tertiary care academic center (CHUM).
  • - No comorbid fibromyalgia as determined by the rheumatologist.
Asymptomatic subjects:
  • - No history of chronic pain syndromes, malformations, injuries, infections or tumors limiting activities of daily living and work.
  • - Not engaged in professional sports.
  • - No skin condition (psoriasis, eczema and others) requiring regular topical treatment.
Exclusion Criteria.
  • - Pregnant and breast-feeding women.
  • - History of spinal surgery or surgery to the extremities.
  • - Previous severe back or extremity fracture.
  • - Spinal or joint corticosteroid injections in the past 3 months.
  • - Major chronic illness (e.g., active cancer, inflammatory rheumatic disease other than psoriatic arthritis, or other chronic uncontrolled condition such as neurological, kidney, liver, cardiac, respiratory, or endocrine disease).
  • - Subjects unable to answer questionnaires in French or English.
  • - Subjects with psychiatric disorders that affect communication.
  • - Subjects who refused to participate.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05447741
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Centre hospitalier de l'Université de Montréal (CHUM)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Nathalie J Bureau, MD MSc
Principal Investigator Affiliation Centre hospitalier de l'Université de Montréal (CHUM)
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries Canada
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Fibromyalgia, Psoriatic Arthritis
Additional Details

In this prospective, cross-sectional, observational study consecutive eligible subjects with FM, PsA, and a group of age- and sex-matched asymptomatic volunteers will undergo a research US examination of the dominant Achilles' tendon, knee medial collateral ligament and common extensor tendon of the elbow. Two operators under the supervision of a musculoskeletal radiologist will perform the US exam. B-mode and Power Doppler ultrasound of each tendon and ligament will be performed for morphological characterization. Then, shear wave elastography (SWE) and radiofrequency (RF) will be acquired. The shear wave speed (SWS) will be measured in the longitudinal plane using shear wave measurements. These features will be compared between groups. The HDK parameters (μ, 1/alpha, κ) will be computed offline, using RF sequences recorded in the longitudinal plane. Demographic features (participant age, sex, body mass index), the Leeds Enthesis Index (LEI) score assessed by the referring clinicians, and the self-administered Health Assessment Questionnaire (HAQ), Brief Pain Inventory (PBI) and Fibromyalgia Impact Questionnaire (FIQ) scores will be available for multivariate analyses.

Arms & Interventions

Arms

: Patients with fibromyalgia

Participants will have a quantitative ultrasound examination of the dominant Achilles' tendon, medial collateral ligament at the femoral epicondyle and common extensor tendon at the lateral epicondyle of the elbow.

: Patients with psoriasis arthritis

Participants will have a quantitative ultrasound examination of the dominant Achilles' tendon, medial collateral ligament at the femoral epicondyle and common extensor tendon at the lateral epicondyle of the elbow.

: Asymptomatic controls

Participants will have a quantitative ultrasound examination of the dominant Achilles' tendon, medial collateral ligament at the femoral epicondyle and common extensor tendon at the lateral epicondyle of the elbow.

Interventions

Diagnostic Test: - Quantitative Ultrasound

Shear Wave Elastography acquisition. RF data acquisition (for HDK parameters calculation).

Contact a Trial Team

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International Sites

Montréal, Quebec, Canada

Status

Address

Centre hospitalier de l'Université de Montréal

Montréal, Quebec, H2X 0C1

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