Clinical trial NCT04464096: Can Musculoskeletal Ultrasound Predict Fall Risk in Rheumatoid Arthritis Patients?
Official title: Can Ankle and Foot Musculoskeletal Ultrasound Predict Fall Risk in Rheumatoid Arthritis Patients?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
foot problems
Fall risk
predictors
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with Rheumatoid arthritis .

Brief summary: Rheumatoid patients have higher fall risk than normal population. Several fall risk factors were studied. No previous study investigated the role of musculoskeletal ultrasound as a predictor of fall risk in rheumatoid arthritis.

Detailed description: Adults with rheumatoid arthritis are exposed to higher risk of fracture. Risk factors included joint tenderness, fatigue, muscle weakness, impaired balance and disease activity.

Musculoskeletal ultrasound is a bed side radiographic tool that gained much attention in the last decade.It can detect stuctural chnges in the musculoskeletal system even before beeing detected by the x ray.

Nowadays, musculoskeletal ultrasound is a very useful tool in examining rheumatoid patients.

No previous study was done to investigate the role of musculoskeletal ultrasound as a predicting factor of fall risk in rheumatoid patients.

Predicting the fall risk in such disease could help setting preventing measures to prevent falls with its sequels.

Eligibility criteria: Inclusion Criteria:

* Adults with Rheumatoid arthritis.

Exclusion Criteria:

* patients aged \< 18 years
* Patients with lower limb disability preventing the participant from performing the mobility tests,
* Patients who were using antidepressants and sedatives.
* Patients with severe comorbidities, severe vision impairment, or hearing loss or neurological diseases that interferes with the mobility as stroke or neuropathy, were also excluded.

Primary outcomes:
measure: range of motion
timeFrame: 1 week
measure: muscle power
timeFrame: 1 week
measure: sensation
timeFrame: 1 week
measure: type of foot
timeFrame: 1 week
measure: Tenitti balance assessment tool
timeFrame: 1 week
measure: Berge Balance assessment
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
citation: Stanmore EK, Oldham J, Skelton DA, O'Neill T, Pilling M, Campbell AJ, Todd C. Fall incidence and outcomes of falls in a prospective study of adults with rheumatoid arthritis. Arthritis Care Res (Hoboken). 2013 May;65(5):737-44. doi: 10.1002/acr.21892.
citation: Hayashibara M, Hagino H, Katagiri H, Okano T, Okada J, Teshima R. Incidence and risk factors of falling in ambulatory patients with rheumatoid arthritis: a prospective 1-year study. Osteoporos Int. 2010 Nov;21(11):1825-33. doi: 10.1007/s00198-009-1150-4. Epub 2010 Jan 30.
citation: Oswald AE, Pye SR, O'Neill TW, Bunn D, Gaffney K, Marshall T, Silman AJ, Symmons DP. Prevalence and associated factors for falls in women with established inflammatory polyarthritis. J Rheumatol. 2006 Apr;33(4):690-4. Epub 2006 Feb 15.
citation: Armstrong C, Swarbrick CM, Pye SR, O'Neill TW. Occurrence and risk factors for falls in rheumatoid arthritis. Ann Rheum Dis. 2005 Nov;64(11):1602-4. doi: 10.1136/ard.2004.031195. Epub 2005 Apr 7.