Intermetatarsal Bursitis in Patients With Rheumatoid Arthritis

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05698563
Collaborator
The Danish Rheumatism Association (Other)
105
2
15.4

Study Details

Study Description

Brief Summary

The aim of the study is to investigate the incidence and clinical implications of intermetatarsal bursitis (IMB) in patients with rheumatoid arthritis (RA).

The hypothesis is that IMB is a cause of pain in patients with RA.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Magnetic resonance imaging
  • Diagnostic Test: Ultrasound
  • Drug: Corticosteroid injection
  • Other: Clinical foot evaluation
  • Other: Picture of the feet
N/A

Detailed Description

Within the recent years more research have focused on IMB in patients with rheumatologic disorders. There is emerging evidence that IMB is an inflammatory alteration in line with synovitis in patients with RA, and presence of IMB have been linked to the early stages of RA, especially due to the focus of the published literature.

The clinical implications of the presence of IMB for the patients are yet to be understood. Limited studies have linked the occurrence of IMB to foot impairment, but no studies have been conducted investigating the direct association between forefoot pain and the presence/absence of IMB.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
105 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This is a prospective diagnostic study, including a patient and a control group. There is a treatment option with standard treatment for the patient group, if there is indication based on the diagnostic imaging.This is a prospective diagnostic study, including a patient and a control group. There is a treatment option with standard treatment for the patient group, if there is indication based on the diagnostic imaging.
Masking:
Single (Outcomes Assessor)
Masking Description:
Outcome assessor is blinded to type of patient they are examining.
Primary Purpose:
Diagnostic
Official Title:
Clinical Implication of Intermetatarsal Bursitis in Patients With Rheumatoid Arthritis
Anticipated Study Start Date :
Jan 17, 2023
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: Patient group

Patients with rheumatoid arthritis and forefoot pain.

Diagnostic Test: Magnetic resonance imaging
MRI scan with contrast of the foot or feet
Other Names:
  • MRI
  • Diagnostic Test: Ultrasound
    Ultrasound scan of the feet
    Other Names:
  • US
  • Drug: Corticosteroid injection
    Administered ultrasound guided to patients with intermetatarsal bursitis

    Other: Clinical foot evaluation
    An examination of the feet

    Other: Picture of the feet
    To evaluate the presence of V-sign/spreading toes

    Other: Control group

    Patients with other rheumatic diseases and absence of forefoot pain.

    Diagnostic Test: Magnetic resonance imaging
    MRI scan with contrast of the foot or feet
    Other Names:
  • MRI
  • Diagnostic Test: Ultrasound
    Ultrasound scan of the feet
    Other Names:
  • US
  • Other: Picture of the feet
    To evaluate the presence of V-sign/spreading toes

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of intermetatarsal bursitis on MRI [8 weeks]

      High intensity on T2 weighted images, low signal on T1. Thin peripheral enhancement on T1 contrast enhanced pictures.

    2. Incidence of intermetatarsal bursitis on US [8 weeks]

      Hypoechoic mass between metatarsal heads. Activity on power/color doppler.

    3. Incidence of other pathology on MRI [8 weeks]

      Other than intermetatarsal bursitis

    4. Incidence of other pathology on US [8 weeks]

      Other than intermetatarsal bursitis

    5. Change in Visual Analogue Score (VAS) score [At inclusion, 1 and 3 month(s) post treatment]

      Pain score related to the foot pain

    Secondary Outcome Measures

    1. Incidence of opening toes [1 day]

      Presence of opening toes/V-sign/spreading toes.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Age > 18 years

    • Forefoot pain and diagnosed with RA (patient group)

    • Diagnosed with an axial arthritis (control group)

    Exclusion Criteria:
    • Age <18 years

    • Open wounds or ongoing infection in the forefoot at the time of examination

    • Persons with a history of significant trauma in the forefoot, e.g. any fracture or previous surgeries in the forefoot

    • Persons who have previously received intermetatarsal treatment (Morton's neuroma or IMB) in the same foot, e.g. injection within 6 months or operation at any time

    • Exclusion from MRI scan only:

    • Persons with contraindications to participate in MRI scan

    • Persons with severely impaired renal function (GFR <30 ml/min)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Rigshospitalet, Denmark
    • The Danish Rheumatism Association

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sif Binder Larsen, Principal Investigator, Rigshospitalet, Denmark
    ClinicalTrials.gov Identifier:
    NCT05698563
    Other Study ID Numbers:
    • H-22033815
    First Posted:
    Jan 26, 2023
    Last Update Posted:
    Jan 26, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sif Binder Larsen, Principal Investigator, Rigshospitalet, Denmark
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 26, 2023