Can Musculoskeletal Ultrasound Predict Fall Risk in Rheumatoid Arthritis Patients?

Rheumatoid Arthritis Clinical Trial

Official title:

Can Ankle and Foot Musculoskeletal Ultrasound Predict Fall Risk in Rheumatoid Arthritis Patients?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04464096
• Other study ID #: 17101098
• Status: Completed
• Start date: April 10, 2018
• Est. completion date: February 15, 2019

Study information

• Verified date: July 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: February 15, 2019
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• non
non

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. Epub 2005 Apr 7. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	range of motion	measured clinically as normal or restricted	1 week
Primary	muscle power	by manual testing with 5 grades where grade 5 means normal power	1 week
Primary	sensation	superficial sensation reported as intact or impaired	1 week
Primary	type of foot	using the wet test . three types of feet either normal, high arched or flat feet.	1 week
Primary	Tenitti balance assessment tool	The maximum total score is 28 points. In general, residents who score below 19 are at a high risk for falls	1 week
Primary	Berge Balance assessment	It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function A score of < 45 indicates individuals may be at greater risk of falling.	1 week