FibromyalgiaNCT05447741
Quantitative Ultrasound of the Enthesis in Fibromyalgia and Psoriatic Arthritis
An observational study of Fibromyalgia and Psoriatic Arthritis, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Psoriatic Arthritis
- What is being tested?
- Quantitative Ultrasound
- How many people
- 81 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2022to 12 Feb 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Subjects with fibromyalgia will be recruited through various outreach approaches such as local newspapers, digital advertising on the Centre hospitalier de l'Université de Montréal (CHUM) platforms, and the collaboration of healthcare providers. Subjects with psoriatic arthritis will be recruited from those patients attending the rheumatology clinics at the CHUM. Asymptomatic volunteers will be recruited from the hospital community through local advertisements.
Who may be able to join
None listed.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Canada1 site
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0C1
About this study
Official title: Fibromyalgia Versus Psoriatic Arthritis: Is Quantitative Ultrasound of the Enthesis a New Marker of Disease?
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.
Read the detailed description
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.
- Conditions
- Fibromyalgia, Psoriatic Arthritis
- Being tested
- Quantitative Ultrasound
- Medical subject headings
- Fibromyalgia, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative UltrasoundDiagnostic test
Shear Wave Elastography acquisition. RF data acquisition (for HDK parameters calculation).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Quantitative Ultrasound | |
| 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. Receives: Diagnostic Test: Quantitative Ultrasound | |
| 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. Receives: Diagnostic Test: Quantitative Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shear wave speed (SWS) (in m/sec).
Area under the ROC curve of the SWS to discriminate between groups.
Measured: Shear Wave Speed will be acquired when patients will be included in the study, from June 2022 to December 2023.
Secondary outcomes (4)
The quantitative ultrasound marker 'μ'.
Statistical analysis of the echo envelope: the mean intensity μ. This marker is unitless.
Area under the ROC curve of the μ parameter to discriminate between groups.
Measured: The mean intensity μ will be acquired when patients will be included in the study, from June 2022 to December 2023.
The quantitative ultrasound marker '1/alpha'.
Statistical analysis of the echo envelope: the acoustic inhomogeneity 1/alpha parameter. This marker is unitless.
Area under the ROC curve of the 1/alpha parameter to discriminate between groups.
Measured: the acoustic inhomogeneity 1/alpha parameter will be acquired when patients will be included in the study, from June 2022 to December 2023.
The quantitative ultrasound marker 'κ'.
Statistical analysis of the echo envelope: the structure parameter κ. This marker is unitless.
Area under the ROC curve of the κ parameter to discriminate between groups.
Measured: The structure parameter κ will be acquired when patients will be included in the study, from June 2022 to December 2023.
Inter-rater reliability
Estimation of the inter-operator reliability of the ultrasound parameter measurements on each enthesis.
The inter-operator reliability will be assessed in terms of intraclass correlation coefficient (ICC 2,1) and coefficient of variation (CV).
Measured: Shear Wave Elastography and RF data acquisitions that will be used for the inter-operator reliability measurements will be conducted when patients will be included in the study, from June 2022 to December 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start1 Oct 2022
- Primary completion12 Feb 2025
- Study completion12 Feb 2025
Why it stopped: The recruitment and examination of participants were halted prematurely due to depleted funds.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The 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
- 81 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie J Bureau, MD MSc, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05447741
- Sponsor's protocol ID
- CE 21.405
- Status last verified
- Feb 2025
- First submitted
- 8 Jun 2022
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibromyalgia Versus Psoriatic Arthritis: Is Quantitative Ultrasound of the Enthesis a New Marker of Disease?
- ClinicalTrials.gov ID
- NCT05447741
- Acronym / sponsor ID
- CE 21.405
- Conditions
- Fibromyalgia, Psoriatic Arthritis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The recruitment and examination of participants were halted prematurely due to depleted funds.
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 12 Feb 2025 (actual)
- Study completion
- 12 Feb 2025 (actual)
- First posted
- 7 Jul 2022 (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 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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with fibromyalgia | – | Diagnostic Test: Quantitative UltrasoundParticipants 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 | – | Diagnostic Test: Quantitative UltrasoundParticipants 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 | – | Diagnostic Test: Quantitative UltrasoundParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects with fibromyalgia will be recruited through various outreach approaches such as local newspapers, digital advertising on the Centre hospitalier de l'Université de Montréal (CHUM) platforms, and the collaboration of healthcare providers. Subjects with psoriatic arthritis will be recruited from those patients attending the rheumatology clinics at the CHUM. Asymptomatic volunteers will be recruited from the hospital community through local advertisements.
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- 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).
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 |
|---|---|---|
| Quantitative UltrasoundShear Wave Elastography acquisition. RF data acquisition (for HDK parameters calculation). | Diagnostic test | Asymptomatic controls, Patients with fibromyalgia, Patients with psoriasis arthritis |
Primary outcome
Shear wave speed (SWS) (in m/sec).
Time frame: Shear Wave Speed will be acquired when patients will be included in the study, from June 2022 to December 2023.
Area under the ROC curve of the SWS to discriminate between groups.
4 secondary outcomes
The quantitative ultrasound marker 'μ'.
Time frame: The mean intensity μ will be acquired when patients will be included in the study, from June 2022 to December 2023.
The quantitative ultrasound marker '1/alpha'.
Time frame: the acoustic inhomogeneity 1/alpha parameter will be acquired when patients will be included in the study, from June 2022 to December 2023.
The quantitative ultrasound marker 'κ'.
Time frame: The structure parameter κ will be acquired when patients will be included in the study, from June 2022 to December 2023.
Inter-rater reliability
Time frame: Shear Wave Elastography and RF data acquisitions that will be used for the inter-operator reliability measurements will be conducted when patients will be included in the study, from June 2022 to December 2023
Results and safety
The study was stopped early (reason given: The recruitment and examination of participants were halted prematurely due to depleted funds.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
Related trials for Fibromyalgia
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
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.
Nathalie J Bureau, MD MSc principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
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 and Psoriatic Arthritis, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 0 inclusion and 8 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: stopped early, as of the sponsor's last update on 25 Feb 2025. 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 Canada. 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?
The study was stopped early (reason given: The recruitment and examination of participants were halted prematurely due to depleted funds.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shear wave speed (SWS) (in m/sec). (time frame: Shear Wave Speed will be acquired when patients will be included in the study, from June 2022 to December 2023.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2025.