Back to resultsIntermetatarsal Bursitis in Patients With Rheumatoid Arthritis
Primary Purpose
Intermetatarsal Bursitis, Rheumatoid Arthritis
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Magnetic resonance imaging
Ultrasound
Corticosteroid injection
Clinical foot evaluation
Picture of the feet
Sponsored by
About this trial
This is an interventional diagnostic trial for Intermetatarsal Bursitis focused on measuring Forefoot pain
Eligibility Criteria
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)
Sites / Locations
- Rigshospitalet GlostrupRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Patient group
Control group
Arm Description
Patients with rheumatoid arthritis and forefoot pain.
Patients with other rheumatic diseases and absence of forefoot pain.
Outcomes
Primary Outcome Measures
Incidence of intermetatarsal bursitis on MRI
High intensity on T2 weighted images, low signal on T1. Thin peripheral enhancement on T1 contrast enhanced pictures.
Incidence of intermetatarsal bursitis on US
Hypoechoic mass between metatarsal heads. Activity on power/color doppler.
Incidence of other pathology on MRI
Other than intermetatarsal bursitis
Incidence of other pathology on US
Other than intermetatarsal bursitis
Change in Visual Analogue Score (VAS) score
Pain score related to the foot pain
Secondary Outcome Measures
Incidence of opening toes
Presence of opening toes/V-sign/spreading toes.
Full Information
NCT ID
NCT05698563
First Posted
January 13, 2023
Last Updated
March 28, 2023
Sponsor
Rigshospitalet, Denmark
Collaborators
The Danish Rheumatism Association
1. Study Identification
Unique Protocol Identification Number
NCT05698563
Brief Title
Intermetatarsal Bursitis in Patients With Rheumatoid Arthritis
Official Title
Clinical Implication of Intermetatarsal Bursitis in Patients With Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2023 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
The Danish Rheumatism Association
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermetatarsal Bursitis, Rheumatoid Arthritis
Keywords
Forefoot pain
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Outcomes Assessor
Masking Description
Outcome assessor is blinded to type of patient they are examining.
Allocation
Non-Randomized
Enrollment
105 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient group
Arm Type
Other
Arm Description
Patients with rheumatoid arthritis and forefoot pain.
Arm Title
Control group
Arm Type
Other
Arm Description
Patients with other rheumatic diseases and absence of forefoot pain.
Intervention Type
Diagnostic Test
Intervention Name(s)
Magnetic resonance imaging
Other Intervention Name(s)
MRI
Intervention Description
MRI scan with contrast of the foot or feet
Intervention Type
Diagnostic Test
Intervention Name(s)
Ultrasound
Other Intervention Name(s)
US
Intervention Description
Ultrasound scan of the feet
Intervention Type
Drug
Intervention Name(s)
Corticosteroid injection
Intervention Description
Administered ultrasound guided to patients with intermetatarsal bursitis
Intervention Type
Other
Intervention Name(s)
Clinical foot evaluation
Intervention Description
An examination of the feet
Intervention Type
Other
Intervention Name(s)
Picture of the feet
Intervention Description
To evaluate the presence of V-sign/spreading toes
Primary Outcome Measure Information:
Title
Incidence of intermetatarsal bursitis on MRI
Description
High intensity on T2 weighted images, low signal on T1. Thin peripheral enhancement on T1 contrast enhanced pictures.
Time Frame
8 weeks
Title
Incidence of intermetatarsal bursitis on US
Description
Hypoechoic mass between metatarsal heads. Activity on power/color doppler.
Time Frame
8 weeks
Title
Incidence of other pathology on MRI
Description
Other than intermetatarsal bursitis
Time Frame
8 weeks
Title
Incidence of other pathology on US
Description
Other than intermetatarsal bursitis
Time Frame
8 weeks
Title
Change in Visual Analogue Score (VAS) score
Description
Pain score related to the foot pain
Time Frame
At inclusion, 1 and 3 month(s) post treatment
Secondary Outcome Measure Information:
Title
Incidence of opening toes
Description
Presence of opening toes/V-sign/spreading toes.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sif B Larsen
Phone
+4521457551
Email
sif.binder.larsen@regionh.dk
Facility Information:
Facility Name
Rigshospitalet Glostrup
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sif B Larsen, MD
Email
sif.binder.larsen@regionh.dk
12. IPD Sharing Statement
Learn more about this trial
Intermetatarsal Bursitis in Patients With Rheumatoid Arthritis
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