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The study was stopped due to health-related issues in the research group, that hindered inrolement of patients.
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| Name | Class |
|---|---|
| The Danish Rheumatism Association | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient group | Other | Patients with rheumatoid arthritis and forefoot pain. |
|
| Control group | Other | Patients with other rheumatic diseases and absence of forefoot pain. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic resonance imaging | Diagnostic Test | MRI scan with contrast of the foot or feet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of intermetatarsal bursitis on MRI | High intensity on T2 weighted images, low signal on T1. Thin peripheral enhancement on T1 contrast enhanced pictures. | 8 weeks |
| Incidence of intermetatarsal bursitis on US | Hypoechoic mass between metatarsal heads. Activity on power/color doppler. | 8 weeks |
| Incidence of other pathology on MRI | Other than intermetatarsal bursitis | 8 weeks |
| Incidence of other pathology on US | Other than intermetatarsal bursitis | 8 weeks |
| Change in Visual Analogue Score (VAS) score | Pain score related to the foot pain | At inclusion, 1 and 3 month(s) post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of opening toes | Presence of opening toes/V-sign/spreading toes. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet Glostrup | Glostrup Municipality | 2600 | Denmark |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| D014463 | Ultrasonography |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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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.
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Outcome assessor is blinded to type of patient they are examining.
| Ultrasound | Diagnostic Test | Ultrasound scan of the feet |
|
|
| Corticosteroid injection | Drug | Administered ultrasound guided to patients with intermetatarsal bursitis |
|
| Clinical foot evaluation | Other | An examination of the feet |
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| Picture of the feet | Other | To evaluate the presence of V-sign/spreading toes |
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |