Rheumatoid ArthritisNCT04550884
Neuropathic Foot and Ankle in Rheumatoid Arthritis : Ultrasound and Nerve Conduction Study
An observational study of Rheumatoid Arthritis, run by Assiut University.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- neuromascular ultrasound
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Oct 2020to Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: RA patients with foot and ankle pain attending at both inpatient department and outpatient clinic
Who may be able to join
- 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
Who cannot join
- Presence of other autoimmune disorders
- Presence of any comorbidities causing neuropathy as Diabetes Mellitus, disc prolapse
Trial locations and contacts
No sites are listed yet.
About this study
- To measure the prevalence of Neuropathic pain in Rheumatoid arthritis patients with ankle and foot pain
- 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- neuromascular ultrasound
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuromascular ultrasoundDiagnostic test
Also called nerve conduction study
neuromascular ultrasound of foot and ankle
What is being measured
The primary outcome is the main question the study is designed to answer.
ultrasound parameters
nerve cross-section
Measured: 3 years
Secondary outcomes (2)
nerve conduction parameters
nerve distal latency
Measured: 3 years
painDETECT questionnaire
screening for neuropathic pain
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study startOct 2020 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Taher Mohamed Amin, Assiut University
- Investigators
- EMAN A AL Kady, professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550884
- Sponsor's protocol ID
- neuropathic foot and ankle
- Status last verified
- Sep 2020
- First submitted
- 1 Sep 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 29684014Aletaha 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 20872595Aseem 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 27859374Colloca 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 28205574El-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 19962619Kaeley 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 30911476Ten 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 31783899Koop 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 26335941McWilliams 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropathic Foot and Ankle in Rheumatoid Arthritis : Ultrasound and Nerve Conduction Study
- ClinicalTrials.gov ID
- NCT04550884
- Acronym / sponsor ID
- neuropathic foot and ankle
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 16 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To measure the prevalence of Neuropathic pain in Rheumatoid arthritis patients with ankle and foot pain
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- RA patients with foot and ankle pain attending at both inpatient department and outpatient clinic
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Presence of other autoimmune disorders
- Presence of any comorbidities causing neuropathy as Diabetes Mellitus, disc prolapse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neuromascular ultrasoundAlso: nerve conduction studyneuromascular ultrasound of foot and ankle | Diagnostic test | – |
Primary outcome
ultrasound parameters
Time frame: 3 years
nerve cross-section
2 secondary outcomes
nerve conduction parameters
Time frame: 3 years
painDETECT questionnaire
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Background: PubMed 29684014Abu-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.
- Background: PubMed 20872595Aletaha 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.
- Background: PubMed 27859374Aseem 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.
- Background: PubMed 28205574Colloca 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.
- BackgroundEl-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.
- Background: PubMed 19962619Fransen 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.
- Background: PubMed 30911476Kaeley 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.
- Background: PubMed 31783899Ten 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.
- Background: PubMed 26335941Koop 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.
- Background: PubMed 28967354McWilliams DF, Walsh DA. Pain mechanisms in rheumatoid arthritis. Clin Exp Rheumatol. 2017 Sep-Oct;35 Suppl 107(5):94-101. Epub 2017 Sep 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
EMAN A AL Kady, professor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara T Amin, student (00201111337547, sarataher.md@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ultrasound parameters (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04550884, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.