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

NCT ID: NCT04550884

Last Updated: 2020-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-31

Study Completion Date

2023-04-30

Brief Summary

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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

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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.

Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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neuromascular ultrasound

neuromascular ultrasound of foot and ankle

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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nerve conduction study

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Sara Taher Mohamed Amin

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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EMAN A AL Kady, professor

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

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Sara T Amin, student

Role: CONTACT

00201111337547

manal hassanein, lecturer

Role: CONTACT

00201062679200

References

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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.

Reference Type BACKGROUND
PMID: 29684014 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20872595 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27859374 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28205574 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 19962619 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30911476 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31783899 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26335941 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28967354 (View on PubMed)

Other Identifiers

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neuropathic foot and ankle

Identifier Type: -

Identifier Source: org_study_id

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