Clinical Implication of Intermetatarsal Bursitis in Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Change in Visual Analogue Score (VAS) score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessor is blinded to type of patient they are examining.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Forefoot pain and diagnosed with RA (patient group)
- •Diagnosed with an axial arthritis (control group)
排除标准
- •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)
研究组 & 干预措施
Patient group
Patients with rheumatoid arthritis and forefoot pain.
干预措施: Clinical foot evaluation (Other)
Patient group
Patients with rheumatoid arthritis and forefoot pain.
干预措施: Picture of the feet (Other)
Patient group
Patients with rheumatoid arthritis and forefoot pain.
干预措施: Ultrasound (Diagnostic Test)
Patient group
Patients with rheumatoid arthritis and forefoot pain.
干预措施: Corticosteroid injection (Drug)
Patient group
Patients with rheumatoid arthritis and forefoot pain.
干预措施: Magnetic resonance imaging (Diagnostic Test)
Control group
Patients with other rheumatic diseases and absence of forefoot pain.
干预措施: Magnetic resonance imaging (Diagnostic Test)
Control group
Patients with other rheumatic diseases and absence of forefoot pain.
干预措施: Ultrasound (Diagnostic Test)
Control group
Patients with other rheumatic diseases and absence of forefoot pain.
干预措施: Picture of the feet (Other)
结局指标
主要结局
Change in Visual Analogue Score (VAS) score
时间窗: At inclusion, 1 and 3 month(s) post treatment
Pain score related to the foot pain
Incidence of intermetatarsal bursitis on MRI
时间窗: 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
时间窗: 8 weeks
Hypoechoic mass between metatarsal heads. Activity on power/color doppler.
Incidence of other pathology on MRI
时间窗: 8 weeks
Other than intermetatarsal bursitis
Incidence of other pathology on US
时间窗: 8 weeks
Other than intermetatarsal bursitis
次要结局
- Incidence of opening toes(1 day)
研究者
Sif Binder Larsen
Principal Investigator
Rigshospitalet, Denmark