Neuropathic Foot and Ankle in Rheumatoid Arthritis : Ultrasound and Nerve Conduction Study
1 other identifier
observational
80
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2020
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2020
CompletedFirst Posted
Study publicly available on registry
September 16, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2023
CompletedSeptember 16, 2020
September 1, 2020
2.5 years
September 1, 2020
September 9, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
ultrasound parameters
nerve cross-section
3 years
Secondary Outcomes (2)
nerve conduction parameters
3 years
painDETECT questionnaire
1 year
Interventions
neuromascular ultrasound of foot and ankle
Eligibility Criteria
RA patients with foot and ankle pain attending at both inpatient department and outpatient clinic
You may qualify if:
- Adults aged ≥ 18 years.
- RA patients who fulfilled the 2010 ACR/European league against Rheumatism(EULAR) criteria for the classification of RA
- RA patients complaining of foot and ankle pain
You may not qualify if:
- Presence of other autoimmune disorders
- Presence of any comorbidities causing neuropathy as Diabetes Mellitus, disc prolapse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (10)
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.
PMID: 29684014BACKGROUNDAletaha 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.
PMID: 20872595BACKGROUNDAseem 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.
PMID: 27859374BACKGROUNDColloca 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.
PMID: 28205574BACKGROUNDEl-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.
BACKGROUNDFransen 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.
PMID: 19962619BACKGROUNDKaeley 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.
PMID: 30911476BACKGROUNDTen 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.
PMID: 31783899BACKGROUNDKoop 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.
PMID: 26335941BACKGROUNDMcWilliams DF, Walsh DA. Pain mechanisms in rheumatoid arthritis. Clin Exp Rheumatol. 2017 Sep-Oct;35 Suppl 107(5):94-101. Epub 2017 Sep 29.
PMID: 28967354BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
EMAN A AL Kady, professor
Assiut University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
September 1, 2020
First Posted
September 16, 2020
Study Start
October 1, 2020
Primary Completion
April 1, 2023
Study Completion
April 1, 2023
Last Updated
September 16, 2020
Record last verified: 2020-09