Neuropathic Foot and Ankle in Rheumatoid Arthritis : Ultrasound and Nerve Conduction Study

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04550884
Collaborator
(none)
80
30

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: neuromascular ultrasound

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
80 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Neuropathic Foot and Ankle in Rheumatoid Arthritis : Ultrasound and Nerve Conduction Study
Anticipated Study Start Date :
Oct 1, 2020
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Outcome Measures

Primary Outcome Measures

  1. ultrasound parameters [3 years]

    nerve cross-section

Secondary Outcome Measures

  1. nerve conduction parameters [3 years]

    nerve distal latency

  2. painDETECT questionnaire [1 year]

    screening for neuropathic pain

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Director: EMAN A AL Kady, professor, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sara Taher Mohamed Amin, principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT04550884
Other Study ID Numbers:
  • neuropathic foot and ankle
First Posted:
Sep 16, 2020
Last Update Posted:
Sep 16, 2020
Last Verified:
Sep 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 16, 2020