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Status unknownNCT04550884Updated Sep 16, 2020

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

An observational study in Rheumatoid Arthritis, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-16.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Sep 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
80
Ages
18 Years and older
Sex
All
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Study 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
Read the 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.

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Conditions studied

  • Rheumatoid Arthritis
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In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's planned enrollment of 80 is below the median of 155 across 1,057 observational studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

RA patients with foot and ankle pain attending at both inpatient department and outpatient clinic

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

Exclusion Criteria:

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

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
80 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testneuromascular ultrasound

    neuromascular ultrasound of foot and ankle

    Also known as: nerve conduction study

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What researchers measure

Primary outcomes

  1. ultrasound parameters

    nerve cross-section

    Time frame: 3 years

Secondary outcomes

  1. nerve conduction parameters

    nerve distal latency

    Time frame: 3 years

  2. painDETECT questionnaire

    screening for neuropathic pain

    Time frame: 1 year

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Abu-Shaheen A, Yousef S, Riaz M, Nofal A, AlFayyad I, Khan S, Heena H. Testing the validity and reliability of the Arabic version of the painDETECT questionnaire in the assessment of neuropathic pain. PLoS One. 2018 Apr 23;13(4):e0194358. doi: 10.1371/journal.pone.0194358. eCollection 2018. PubMed 29684014 ↗
  • Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Menard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010 Sep;62(9):2569-81. doi: 10.1002/art.27584. PubMed 20872595 ↗
  • Aseem F, Williams JW, Walker FO, Cartwright MS. Neuromuscular ultrasound in patients with carpal tunnel syndrome and normal nerve conduction studies. Muscle Nerve. 2017 Jun;55(6):913-915. doi: 10.1002/mus.25462. Epub 2016 Nov 18. PubMed 27859374 ↗
  • Colloca L, Ludman T, Bouhassira D, Baron R, Dickenson AH, Yarnitsky D, Freeman R, Truini A, Attal N, Finnerup NB, Eccleston C, Kalso E, Bennett DL, Dworkin RH, Raja SN. Neuropathic pain. Nat Rev Dis Primers. 2017 Feb 16;3:17002. doi: 10.1038/nrdp.2017.2. PubMed 28205574 ↗
  • El-Hewala, A. E.-S., Soliman, S., Labeeb, A., Zytoon, A. and El-Shanawany, A. (2016) 'Foot neuropathy in rheumatoid arthritis patients: clinical, electrophysiological, and ultrasound studies', Egyptian Rheumatology and Rehabilitation. Springer Science and Business Media LLC, 43(3), p. 85. doi: 10.4103/1110-161x.189640.
  • Fransen J, van Riel PL. The Disease Activity Score and the EULAR response criteria. Rheum Dis Clin North Am. 2009 Nov;35(4):745-57, vii-viii. doi: 10.1016/j.rdc.2009.10.001. PubMed 19962619 ↗
  • Kaeley N, Ahmad S, Pathania M, Kakkar R. Prevalence and patterns of peripheral neuropathy in patients of rheumatoid arthritis. J Family Med Prim Care. 2019 Jan;8(1):22-26. doi: 10.4103/jfmpc.jfmpc_260_18. PubMed 30911476 ↗
  • Ten Klooster PM, de Graaf N, Vonkeman HE. Association between pain phenotype and disease activity in rheumatoid arthritis patients: a non-interventional, longitudinal cohort study. Arthritis Res Ther. 2019 Nov 29;21(1):257. doi: 10.1186/s13075-019-2042-4. PubMed 31783899 ↗
  • Koop SM, ten Klooster PM, Vonkeman HE, Steunebrink LM, van de Laar MA. Neuropathic-like pain features and cross-sectional associations in rheumatoid arthritis. Arthritis Res Ther. 2015 Sep 3;17(1):237. doi: 10.1186/s13075-015-0761-8. PubMed 26335941 ↗
  • McWilliams DF, Walsh DA. Pain mechanisms in rheumatoid arthritis. Clin Exp Rheumatol. 2017 Sep-Oct;35 Suppl 107(5):94-101. Epub 2017 Sep 29. PubMed 28967354 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04550884
Lead sponsor
Assiut University
Responsible party
Sara Taher Mohamed Amin (principal investigator, Assiut University) — Principal investigator
First posted
Sep 16, 2020
Start date
Oct 2020 (estimated)
Primary completion
Apr 2023 (estimated)
Completion
Apr 2023 (estimated)
Last update
Sep 16, 2020

Study contacts

Sara T Amin, student
Contact
sarataher.md@gmail.com
00201111337547
manal hassanein, lecturer
Contact
Manal_hassanien@yahoo.com
00201062679200
EMAN A AL Kady, professor
study director · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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