Clinical trial NCT04550884: Neuropathic Foot and Ankle in Rheumatoid Arthritis : Ultrasound and Nerve Conduction Study
Official title: Neuropathic Foot and Ankle in Rheumatoid Arthritis : Ultrasound and Nerve Conduction Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: RA patients with foot and ankle pain attending at both inpatient department and outpatient clinic

Brief summary: 1. To measure the prevalence of Neuropathic pain in Rheumatoid arthritis patients with ankle and foot pain
2. To evaluate the role of Neuromuscular Ultra sound (NMUS) and nerve conduction study (NCS) in assessment of Neuropathic foot and ankle in Rheumatoid arthritis patients

Detailed description: Rheumatoid arthritis (RA) is a common chronic systemic autoimmune disease that primarily affects the lining of the synovial joints which symmetrically involves the small joints, can cause cartilage and bone damage and associated with progressive disability, premature deaths, and socioeconomic burdens .

In RA, neuropathic pain "which is defined as pain caused by a lesion or a disease of the somatosensory system" , could be suggested by :nerve compression, associated comorbidities and vascuilitis .

Despite the recent advancement in RA treatment, neuropathic pain remains a cause of persistent pain even in controlled disease activity.

The prevalence of clinical neuropathy varies from 0.5% to 85% in patients with RA, which can cause functional disability . Foot and ankle pain is highly prevalent in RA with peripheral neuropathy is a common contributor to it . In previous studies , it was found that the most foot neuropathies are of tarsal tunnel syndrome, peroneal nerve entrapment and pure sensory axonal neuropathy.

For evaluation of neuropathic foot and ankle in RA , electrophysiological and imaging techniques can be very useful.

Nerve conduction study (NCS) is the electrodiagnostic evaluation of the function of peripheral nerves ,it can provide information regarding the presence, severity and location of a lesion, symmetricity of neuropathy, mononeuropathy or disorders affecting the neuromuscular junctions. Also, the functional modality most involved (sensory or motor) and the predominant pattern of pathology (e.g., axonal, demyelinating, or both.

Neuromascular ultrasond(NMUS) is a new modality of diagnosis developed in the past 20 years , and it can assess anatomical abnormalities that can't be evaluated by NCS NMUS being noninvasive and inexpensive diagnostic modality , it has been introduced as a complement to NCS for diagnosis of nerve conditions.

Eligibility criteria: Inclusion Criteria:

1. Adults aged ≥ 18 years.
2. RA patients who fulfilled the 2010 ACR/European league against Rheumatism(EULAR) criteria for the classification of RA
3. RA patients complaining of foot and ankle pain

Exclusion Criteria:

1. Presence of other autoimmune disorders
2. Presence of any comorbidities causing neuropathy as Diabetes Mellitus, disc prolapse

Primary outcomes:
measure: ultrasound parameters
timeFrame: 3 years
Secondary outcomes:
measure: nerve conduction parameters
timeFrame: 3 years
measure: painDETECT questionnaire
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: EMAN A AL Kady, professor
role: STUDY_DIRECTOR
References:
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