Department of Rheumatology, CHU Montpellier
Montpellier, 34295, France
Location status: Recruiting
NCT Number: NCT03650673
The late-stage forms of degenerative osteoarthritis (OA) are very debilitating and less affordable to therapy. The main objective is to identify early onset symptoms of hand OA patients through imaging techniques (such as ultrasound and MRI). Our primary endpoint is to specify patients with high risk of radiological profression (X-ray).
Interested in participating?
Request Info18 year–60 year
All sexes
Interventional
Not applicable
Montpellier, 34295, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Clinical definition:
At least one of the following 4 criteria: Pain or stiffness or swelling or deformity of a digital joint (IPP and / or IPD) A breach of at least one PPI and / or IPD Age under 60 at the time of the first symptoms Clinical symptoms have been changing for less than 3 years
Radiographic definition:
The presence of the achievement of at least one PPI and / or IPD. Presence of at least two of the following three criteria: pinching, marginal subchondral condensation, marginal osteophyte Erosion on radiography is not an exclusion criteria
Exclusion criteria
Clinical examination with questionnaires, Biological collection, Imaging (radiography, densitometry, ultrasound, and MRI)
Time frame: 2 years
Evaluation of prognostic role of imaging factors in x-ray progression of early onset hand osteoarthritis
Time frame: 2 years
Photographs of the patients' hands will be taken at each visit.
Time frame: 2 years
Photographs of the patients' hands will be taken at each visit.
Time frame: 2 years
The intensity of pain over the last 48 hours will be assessed by the patient at each visit on a visual analogue scale (VAS). EVA pain (visual analogue scale over 100 mm): one-dimensional measurement of the intensity of pain. EVA pain is a continuous scale consisting of a horizontal line from 0 (no pain) to 100 mm (maximum pain)
Time frame: 2 years
The activity of the disease over the last 48 hours will be evaluated at each visit by the patient and the doctor on a visual analog scale from 0 (no pain) to 100 mm (maximum pain)
Time frame: 2 years
The aesthetic impact of osteoarthritis of the hands will be evaluated at each visit by the patient on a visual analog scale from 0 (no pain) to 100 mm (maximum pain)
Time frame: 2 years
Time frame: 2 years
Time frame: 2 years
Time frame: 2 years
The impact on pain and function measured by the AUSCAN questionnaire. This is a functional index including 15 questions with a specific orientation to osteoarthritis of the hands, assessing pain / stiffness and function. The score varies from 0 to 60. Fill in the questionnaire: 7 min
Time frame: 2 years
The impact on pain and function measured by the COCHIN functional index wich is oriented towards AD. It includes 18 questions, ranging from 0 to 5, and is particularly interested in the impact of osteoarthritis of the hands on the daily activities (cooking, clothing, hygiene, office ...) of the patient. The score varies from 0 to 90. Questionnaire filling time: 5 min
Time frame: 2 years
The impact on pain and function measured by a 6-minute walk test that characterizes an overall assessment of functional ability to exercise. The patient is asked to walk as much as possible for 6 minutes (round trip in a 30m corridor), the pace of walking is freely chosen (ATS Recommendations, 2002)
Time frame: 2 years
The short version with 7 questions will be used
Time frame: 2 years
The WPAI questionnaire is an instrument for measuring deficiencies in paid work and unpaid work over the last 7 days. It measures absenteeism, presenteeism as well as the deficiencies of unpaid activity due to a health problem. It contains 6 questions and has already been used during AD
Time frame: 2 years
The Health Assessment Questionnaire (HAQ) is a measure of quality of life in health. The questionnaire is designed to be completed by the patient himself, without the help of a doctor. We will use an adaptation of the HAQ, the Modified Health Assessment Questionnaire (MHAQ), as in the Kwok et al. Study, with 8 questions about the function of the hand. The score ranges from 0 to 3. The average score reported in osteoarthritis studies is 0.8. It is 0.49 in the global population.
Time frame: 2 years
The SF-36 questionnaire assesses the quality of life. It is a validated international questionnaire. It consists of 36 items evaluating 8 dimensions. It can be used in health economics studies as a variable in the calculation of a Quality Adjusted Life Year (QALY) to determine the cost-effectiveness of a health intervention. Fill in the questionnaire: 10 min.
Time frame: 2 years
This score varies between 0 and 1: 0 represents death, and 1 the best quality of life possible. So, this score indicates the decrease in quality of life compared to an optimal state of health. The more desirable a health state, the higher the score associated with it. Negative scores are possible if the subject perceives a state of health worse than death. The EQ-5D-3L includes the following five dimensions: mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension has 3 levels: absence of problems, presence of problems and extreme problems. Questionnaire filling time: 5 min
Time frame: 2 years
It is an international questionnaire validated with 6 items, which assesses the aesthetic impact of osteoarthritis of the hands. The questionnaire includes the function of the overall hand, the activities of daily life, the pain, the work, the appearance of the hands and the satisfaction of the patient with the functionality of his hands. In the ladder pain, a high score indicates more intense pain, while in the rest of the items, a better score reveals better hand functionality. Duplicate filling time: 15 min.
Time frame: 2 years
This questionnaire assesses the psychological impact of the patient. It consists of 14 questions with 4 possible answers. This score makes it possible to differentiate a level of anxiety and a level of depression according to the answers. Each sub-scale varies from 0 to 21. Questionnaire filling time: 5 min
Time frame: 2 years
The aesthetic impact of osteoarthritis of the hands will be evaluated at each visit by the patient with the help of the Michigan Hand Outcome Questionnaire. It is an international questionnaire validated with 6 items, which assesses the aesthetic impact of osteoarthritis of the hands. The questionnaire includes the function of the overall hand, the activities of daily life, the pain, the work, the appearance of the hands and the satisfaction of the patient with the functionality of his hands. In the ladder pain, a high score indicates more intense pain, while in the rest of the items, a better score reveals better hand functionality. Duplicate filling time: 15 min (MHQ)
Contact information is provided by the study sponsor or research team.
University Hospital, Montpellier
Other
A Prospective Cohort Study of Patients Suffering From Hand Osteoarthritis
Acronym: COARDIG
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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