Intermetatarsal Bursitis in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Clinical Implication of Intermetatarsal Bursitis in Patients With Rheumatoid Arthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05698563
• Other study ID #: H-22033815
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2023
• Est. completion date: May 2024

Study information

• Verified date: March 2023
• Source: Rigshospitalet, Denmark
• Contact: Sif B Larsen
• Phone: +4521457551
• Email: sif.binder.larsen[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: May 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Bursitis
• Rheumatoid Arthritis

Intervention

Diagnostic Test:
• Magnetic resonance imaging
MRI scan with contrast of the foot or feet
• Ultrasound
Ultrasound scan of the feet

Drug:
• Corticosteroid injection
Administered ultrasound guided to patients with intermetatarsal bursitis

Other:
• Clinical foot evaluation
An examination of the feet
• Picture of the feet
To evaluate the presence of V-sign/spreading toes

Locations

Country	Name	City	State
Denmark	Rigshospitalet Glostrup	Glostrup

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	The Danish Rheumatism Association

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Incidence of intermetatarsal bursitis on US	Hypoechoic mass between metatarsal heads. Activity on power/color doppler.	8 weeks
Primary	Incidence of other pathology on MRI	Other than intermetatarsal bursitis	8 weeks
Primary	Incidence of other pathology on US	Other than intermetatarsal bursitis	8 weeks
Primary	Change in Visual Analogue Score (VAS) score	Pain score related to the foot pain	At inclusion, 1 and 3 month(s) post treatment
Secondary	Incidence of opening toes	Presence of opening toes/V-sign/spreading toes.	1 day