Intermetatarsal Bursitis, Rheumatoid Arthritis
Conditions
Keywords
Forefoot pain
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.
Interventions
DIAGNOSTIC_TESTMagnetic resonance imaging
MRI scan with contrast of the foot or feet
DIAGNOSTIC_TESTUltrasound
Ultrasound scan of the feet
DRUGCorticosteroid injection
Administered ultrasound guided to patients with intermetatarsal bursitis
OTHERClinical foot evaluation
An examination of the feet
OTHERPicture of the feet
To evaluate the presence of V-sign/spreading toes
Sponsors
The Danish Rheumatism Association
Rigshospitalet, Denmark
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessor is blinded to type of patient they are examining.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Incidence of intermetatarsal bursitis on US | 8 weeks | Hypoechoic mass between metatarsal heads. Activity on power/color doppler. |
| Incidence of other pathology on MRI | 8 weeks | Other than intermetatarsal bursitis |
| Incidence of other pathology on US | 8 weeks | Other than intermetatarsal bursitis |
| Change in Visual Analogue Score (VAS) score | At inclusion, 1 and 3 month(s) post treatment | Pain score related to the foot pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of opening toes | 1 day | Presence of opening toes/V-sign/spreading toes. |
Countries
Denmark
Outcome results
None listed