Back to resultsA Prospective Cohort Study of Patients Suffering From Hand Osteoarthritis Symptoms (COARDIG)
Primary Purpose
Hand Osteoarthritis
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Identification of subgroups of patients with early AD with risk of progression
Sponsored by
About this trial
This is an interventional health services research trial for Hand Osteoarthritis focused on measuring Hand osteoarthritis, Prospective cohort, Cartilage, Mobility
Eligibility Criteria
Inclusion Criteria:
- Early digital osteoarthritis must combine the clinical AND radiological definition.
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
- Consent form signed
Exclusion criteria:
- patients suffering from rheumatoid arthritis, rheumatoid psoriasis or any other inflammatory rheumatism
- patients suffering from metabolic diseasis such as gout, hemochromatosis, Wilson's disease; or from congenital disease such as displasie, osteogenesis,
- Presence of advanced radiographic osteoarthritis based in Kellgreen Lawrence score (=4) in one joint among the 10 previous sites.
- Not able to provide a sample of blood for any reasons
- MRI contraindication
- Being in exclusion period determined by another previous study
- Subject non affiliated to social insurance
- Pregnant or lactating women
- Vulnerable people based in L1121-5 article of CSP
- Elderly subject or protected subjects disabled to give their consent
- Subjects private of freedom by court or administrative order
Sites / Locations
- Department of Rheumatology, CHU MontpellierRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Diagnostic Test: Identification of subgroups of patients with
Arm Description
Outcomes
Primary Outcome Measures
Radiographic progression judged by the number of joints whose KL index has evolved
Evaluation of prognostic role of imaging factors in x-ray progression of early onset hand osteoarthritis
Secondary Outcome Measures
The number of painful / swollen or deformed joints in the hands.
Photographs of the patients' hands will be taken at each visit.
The location of painful / swollen or deformed joints in the hands.
Photographs of the patients' hands will be taken at each visit.
The intensity of pain over the last 48 hours
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)
The activity of the disease over the last 48 hours
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)
The aesthetic impact of osteoarthritis of the hands
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)
The number of consumption of care in the month preceding the visit
The number of hand surgery during follow-up 56/5000 The number of a hand surgery during follow-up
The grip force measured by a dynamometer
The impact on pain and function on the hand measured by the AUSCAN questionnaire
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
The impact on pain and function on the hand measured by the COCHIN functional index
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
The impact on pain and function on the hand measured by a 6-minute walk test
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)
The impact on pain and function measured the IPAQ International Physical Activity Questionnaire
The short version with 7 questions will be used
The professional impact measured by the WPAI questionnaire which measures the deficiencies of paid work and unpaid work over the last 7 days
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
Impact on quality of life measured by the Health Assessment Questionnaire (HAQ)
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.
The impact on the quality of life measured by the SF-36 questionnaire
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.
The impact on the quality of life measured by the EQ-5D-3L questionnaire (https://euroqol.org)
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
The Impact on Quality of Life Measured by the Michigan Hand Outcome Questionnaire (MHQ)
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.
The psychological impact of pain measured by the HAD questionnaire (Hospital Anxiety and Depression)
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
The aesthetic impact of osteoarthritis of the hands with the Michigan Hand Outcome Questionnaire
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)
Full Information
NCT ID
NCT03650673
First Posted
August 22, 2018
Last Updated
September 11, 2023
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT03650673
Brief Title
A Prospective Cohort Study of Patients Suffering From Hand Osteoarthritis Symptoms
Acronym
COARDIG
Official Title
A Prospective Cohort Study of Patients Suffering From Hand Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2019 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Osteoarthritis
Keywords
Hand osteoarthritis, Prospective cohort, Cartilage, Mobility
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diagnostic Test: Identification of subgroups of patients with
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
Identification of subgroups of patients with early AD with risk of progression
Intervention Description
Clinical examination with questionnaires, Biological collection, Imaging (radiography, densitometry, ultrasound, and MRI)
Primary Outcome Measure Information:
Title
Radiographic progression judged by the number of joints whose KL index has evolved
Description
Evaluation of prognostic role of imaging factors in x-ray progression of early onset hand osteoarthritis
Time Frame
2 years
Secondary Outcome Measure Information:
Title
The number of painful / swollen or deformed joints in the hands.
Description
Photographs of the patients' hands will be taken at each visit.
Time Frame
2 years
Title
The location of painful / swollen or deformed joints in the hands.
Description
Photographs of the patients' hands will be taken at each visit.
Time Frame
2 years
Title
The intensity of pain over the last 48 hours
Description
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
Title
The activity of the disease over the last 48 hours
Description
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
Title
The aesthetic impact of osteoarthritis of the hands
Description
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
Title
The number of consumption of care in the month preceding the visit
Time Frame
2 years
Title
The number of hand surgery during follow-up 56/5000 The number of a hand surgery during follow-up
Time Frame
2 years
Title
The grip force measured by a dynamometer
Time Frame
2 years
Title
The impact on pain and function on the hand measured by the AUSCAN questionnaire
Description
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
Title
The impact on pain and function on the hand measured by the COCHIN functional index
Description
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
Title
The impact on pain and function on the hand measured by a 6-minute walk test
Description
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
Title
The impact on pain and function measured the IPAQ International Physical Activity Questionnaire
Description
The short version with 7 questions will be used
Time Frame
2 years
Title
The professional impact measured by the WPAI questionnaire which measures the deficiencies of paid work and unpaid work over the last 7 days
Description
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
Title
Impact on quality of life measured by the Health Assessment Questionnaire (HAQ)
Description
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
Title
The impact on the quality of life measured by the SF-36 questionnaire
Description
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
Title
The impact on the quality of life measured by the EQ-5D-3L questionnaire (https://euroqol.org)
Description
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
Title
The Impact on Quality of Life Measured by the Michigan Hand Outcome Questionnaire (MHQ)
Description
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
Title
The psychological impact of pain measured by the HAD questionnaire (Hospital Anxiety and Depression)
Description
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
Title
The aesthetic impact of osteoarthritis of the hands with the Michigan Hand Outcome Questionnaire
Description
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)
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Early digital osteoarthritis must combine the clinical AND radiological definition.
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
- Consent form signed
Exclusion criteria:
patients suffering from rheumatoid arthritis, rheumatoid psoriasis or any other inflammatory rheumatism
patients suffering from metabolic diseasis such as gout, hemochromatosis, Wilson's disease; or from congenital disease such as displasie, osteogenesis,
Presence of advanced radiographic osteoarthritis based in Kellgreen Lawrence score (=4) in one joint among the 10 previous sites.
Not able to provide a sample of blood for any reasons
MRI contraindication
Being in exclusion period determined by another previous study
Subject non affiliated to social insurance
Pregnant or lactating women
Vulnerable people based in L1121-5 article of CSP
Elderly subject or protected subjects disabled to give their consent
Subjects private of freedom by court or administrative order
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yves-Marie PERS, MD
Phone
+33 618993804
Email
ympers2000@yahoo.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yves-Marie PERS, MD
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Rheumatology, CHU Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle MOYA, CRA
Phone
+33 609980911
Email
michellemoya@orange.fr
12. IPD Sharing Statement
Learn more about this trial
A Prospective Cohort Study of Patients Suffering From Hand Osteoarthritis Symptoms
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