Pilot Study of Ultrasound in Rheumatoid Arthritis
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|ClinicalTrials.gov Identifier: NCT02064400|
Recruitment Status : Completed
First Posted : February 17, 2014
Last Update Posted : June 26, 2015
Little is currently known as to the predictive value of ultrasound in guiding the decision to taper drug treatment in patients with stable rheumatoid arthritis, nor the influence that patients' views and opinions regarding their medications may have upon this. In this study, patients with stable rheumatoid arthritis will undergo a simple examination of their joints to look for any swelling or tenderness followed by an ultrasound scan to look for joint inflammation. Half of the patients will also complete an interview to assess their views and opinions of arthritis drug treatment. The study will be completed in a single patient visit - no invasive tests will be performed, and no changes to treatment will be made.
This study is being conducted as part of a Masters degree from Newcastle University. The results of this study will be used to inform the feasibility of inclusion of ultrasound assessment within the design of a future PhD study to investigate potential markers of remission in patients with rheumatoid arthritis.
|Condition or disease||Intervention/treatment|
|Rheumatoid Arthritis||Other: Musculoskeletal Ultrasound Other: Semi-structured patient interview|
|Study Type :||Observational|
|Actual Enrollment :||17 participants|
|Official Title:||A Pilot Study of Musculoskeletal Ultrasound Assessment in Patients With Rheumatoid Arthritis|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
Observational study group
Musculoskeletal ultrasound (all patients) and semi-structured patient interview (anticipated maximum 15 patients)
Other: Musculoskeletal Ultrasound
7-joint musculoskeletal ultrasound scan
Other: Semi-structured patient interview
Semi-structured patient interview
- Evidence of reliability of intra- and inter-rater ultrasound agreement for power Doppler synovitis score [ Time Frame: At recruitment ]Defined as Kappa statistic of at least 0.4.
- Qualitative data relating to patients' views and opinions of their arthritis medication [ Time Frame: At recruitment ]Based upon data collected by a semi-structured interview approach and analysed using standard qualitative techniques.
- Simplified Disease Activity Index (SDAI) [ Time Frame: At recruitment ]
- Disease Activity Score in 28 joints (DAS-28) [ Time Frame: At recruitment ]
- Disease Activity Score (DAS) [ Time Frame: At recruitment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02064400
|Musculoskeletal Outpatient Department, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust|
|Newcastle upon Tyne, United Kingdom, NE7 7DN|
|Principal Investigator:||John D Isaacs, PhD, MB BS||Newcastle University|