Back to resultsFollow-up of Osteo-articular Biomarkers After Spa Therapy in a Population With Knee Osteoarthritis and Their Correlation With the Clinical Evolution (BIOMARTHROSE)
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood collection arm
Sponsored by
About this trial
This is an interventional other trial for Knee Osteoarthritis focused on measuring Knee osteoarthritis, spa therapy, osteo-articular markers
Eligibility Criteria
Inclusion Criteria:
Patient with knee osteoarthritis defined according to the recommendations of the American College of Rheumatology (ACR):
- painful articulation and at least one of the following three criteria: age > 50 years and/or articular crepitation and/or morning stiffness less than 30min
- and radiographic sign of gonarthrosis with osteophyte (on X-rays of less than 3 years).
- Patient can come to the final visit at 6 months and living within a perimeter of 30km around Dax.
- Patient affiliated to a social security scheme.
Exclusion Criteria:
- Osteoarthritis limited to patellofemoral joint.
- A previous spa therapy of less than 6 months.
- Spa therapies with double indication rheumatology and phlebology.
- Patient with osteoporosis.
- A known hepatocellular failure or known acute or end-stage renal failure.
- Severe depressive syndrome, psychotic syndrome, immune deficiency, cardiopathy, evolutive neoplasia or infection.
- Infiltration and/or viscosupplementation < 6 months.
- Change in anti-osteoarthritis treatment of less than 3 months.
- Patient under tutorship or curatorship.
Sites / Locations
- centre hospitalier Dax
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Blood collection arm
Arm Description
Blood collection will be performed before the spa therapy (Day 0), at the end of the spa therapy (Week 3) and 6 months later (M6).
Outcomes
Primary Outcome Measures
Describe the change of serum level of Hyaluronic acid (a marker of synovial inflammation)
Measure of serum level of Hyaluronic acid before the spa therapy (Day 0), at the end of the spa therapy (Week 3) and 6 months later (M6).
Secondary Outcome Measures
Marker of cartilage degradation: Coll2-1
Measure of biological marker of cartilage degradation (Coll2-1) before the spa therapy (Day 0), at the end of the spa therapy (Week 3) and 6 months later (M6).
Marker of bone resorption: CTX1
Measure of biological marker of bone resorption (CTX1) before the spa therapy (Day 0), at the end of the spa therapy (Week 3) and 6 months later (M6).
Index of symptomatic severity of knee osteoarthritis or WOMAC
Patients will have been asked to answer symptom questionnaire (WOMAC) before the spa therapy (Day 0), at the end of the spa therapy (Week 3) and 6 months later (M6). It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items), Stiffness (2 items) and Physical Function (17 items). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function.
Pain evaluation Visual Analogue Scale
Patients will have been asked to answer pain questionnaire (EVA) before the spa therapy (Day 0), at the end of the spa therapy (Week 3) and 6 months later (M6). The EVA is in the form of a 10 cm plastic strip graduated in mm. On the face presented to the patient, there is a cursor which he mobilizes along a straight line, one end of which corresponds to "No pain", and the other to "Maximum pain imaginable". The patient must, along this line, position the cursor at the place that best locates his pain. On the other side, there are millimeter graduations seen only by the caregiver. The position of the cursor mobilized by the patient makes it possible to read the intensity of the pain, which is measured in mm.
SF 36 Quality of Life Questionnaire
Patients will have been asked to answer and quality of life questionnaire (SF-36) before the spa therapy (Day 0), at the end of the spa therapy (Week 3) and 6 months later (M6). There are 11 questions in SF-36, with 36 items in total.
The SF-36 items are divided into 8 different areas: Physical component (4 areas: Physical activity, Limitations due to physical condition, Physical pain, Perceived health) and Mental component (4 areas: Life and relationships with others , Psychic health, Limitations due to mental state, Vitality).
It is requested to respond according to the last 4 weeks. The rating system recommended for the SF-36 is a weighted Likert system for each item. The items in the subscales are totaled in order to obtain a summary score for each subscale or dimension. Each of the 8 summary scores is linearly transformed on a scale of 0 (negative for health) to 100 (favorable for health) to obtain a score for each subscale.
Global clinical evaluation with kne flexion and joint swelling
A global clinical evaluation done with evaluation of different exams: Knee flexion (in degrees), joint swelling (measuring the perimeter of the joint (in cm)) before the spa therapy (Day 0), at the end of the spa therapy (Week 3) and 6 months later (M6).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04308369
Brief Title
Follow-up of Osteo-articular Biomarkers After Spa Therapy in a Population With Knee Osteoarthritis and Their Correlation With the Clinical Evolution
Acronym
BIOMARTHROSE
Official Title
Follow-up of Osteo-articular Biomarkers After Spa Therapy at Dax in a Population With Knee Osteoarthritis and Their Correlation With the Clinical Evolution
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ch Mont de Marsan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Spa therapy is used in the treatment of various diseases and mainly osteoarthritis. Knee osteoarthritis is a very common rheumatic disease whose prevalence increases with longer life span and is a public health problem.
The Forestier and al. study highlighted the actual benefit and confirmed the improvement of the quality of life and pain of the knee osteoarthritis patients from 6 months of spa treatment.[1] A significant decrease of 30% in the rate of Serum Hyaluronic Acid at 6 months after the end of the spa therapy was also highlighted in the Canteloup et al study.[6] This study aims to measure different osteoarticular biomarkers (hyaluronic acid, coll2-1 and CTX1) before, at the end of the spa therapy and 6 months after the spa therapy and correlate with the clinical evaluation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Knee osteoarthritis, spa therapy, osteo-articular markers
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
interventional study with minimal risk. Ony blood collection done during study to determinate biological marker level
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Blood collection arm
Arm Type
Other
Arm Description
Blood collection will be performed before the spa therapy (Day 0), at the end of the spa therapy (Week 3) and 6 months later (M6).
Intervention Type
Biological
Intervention Name(s)
Blood collection arm
Intervention Description
Blood collection will be performed before the spa therapy (Day 0), at the end of the spa therapy (Week 3) and 6 months later (M6). In this study, blood samples will be collected by a nurse of the service and centralized by the laboratory of Medical Biology of the General hospital of Dax.
Primary Outcome Measure Information:
Title
Describe the change of serum level of Hyaluronic acid (a marker of synovial inflammation)
Description
Measure of serum level of Hyaluronic acid before the spa therapy (Day 0), at the end of the spa therapy (Week 3) and 6 months later (M6).
Time Frame
6 months (timepoint: at Day 0, Week 3 and month 6)
Secondary Outcome Measure Information:
Title
Marker of cartilage degradation: Coll2-1
Description
Measure of biological marker of cartilage degradation (Coll2-1) before the spa therapy (Day 0), at the end of the spa therapy (Week 3) and 6 months later (M6).
Time Frame
6 months (timepoint: at Day 0, Week 3 and month 6)
Title
Marker of bone resorption: CTX1
Description
Measure of biological marker of bone resorption (CTX1) before the spa therapy (Day 0), at the end of the spa therapy (Week 3) and 6 months later (M6).
Time Frame
6 months (timepoint: at Day 0, Week 3 and month 6)
Title
Index of symptomatic severity of knee osteoarthritis or WOMAC
Description
Patients will have been asked to answer symptom questionnaire (WOMAC) before the spa therapy (Day 0), at the end of the spa therapy (Week 3) and 6 months later (M6). It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: Pain (5 items), Stiffness (2 items) and Physical Function (17 items). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function.
Time Frame
6 months (timepoint: at Day 0, Week 3 and month 6)
Title
Pain evaluation Visual Analogue Scale
Description
Patients will have been asked to answer pain questionnaire (EVA) before the spa therapy (Day 0), at the end of the spa therapy (Week 3) and 6 months later (M6). The EVA is in the form of a 10 cm plastic strip graduated in mm. On the face presented to the patient, there is a cursor which he mobilizes along a straight line, one end of which corresponds to "No pain", and the other to "Maximum pain imaginable". The patient must, along this line, position the cursor at the place that best locates his pain. On the other side, there are millimeter graduations seen only by the caregiver. The position of the cursor mobilized by the patient makes it possible to read the intensity of the pain, which is measured in mm.
Time Frame
6 months (timepoint: at Day 0, Week 3 and month 6)
Title
SF 36 Quality of Life Questionnaire
Description
Patients will have been asked to answer and quality of life questionnaire (SF-36) before the spa therapy (Day 0), at the end of the spa therapy (Week 3) and 6 months later (M6). There are 11 questions in SF-36, with 36 items in total.
The SF-36 items are divided into 8 different areas: Physical component (4 areas: Physical activity, Limitations due to physical condition, Physical pain, Perceived health) and Mental component (4 areas: Life and relationships with others , Psychic health, Limitations due to mental state, Vitality).
It is requested to respond according to the last 4 weeks. The rating system recommended for the SF-36 is a weighted Likert system for each item. The items in the subscales are totaled in order to obtain a summary score for each subscale or dimension. Each of the 8 summary scores is linearly transformed on a scale of 0 (negative for health) to 100 (favorable for health) to obtain a score for each subscale.
Time Frame
6 months (timepoint: at Day 0, Week 3 and month 6)
Title
Global clinical evaluation with kne flexion and joint swelling
Description
A global clinical evaluation done with evaluation of different exams: Knee flexion (in degrees), joint swelling (measuring the perimeter of the joint (in cm)) before the spa therapy (Day 0), at the end of the spa therapy (Week 3) and 6 months later (M6).
Time Frame
6 months (timepoint: at Day 0, Week 3 and month 6)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patient with knee osteoarthritis defined according to the recommendations of the American College of Rheumatology (ACR):
painful articulation and at least one of the following three criteria: age > 50 years and/or articular crepitation and/or morning stiffness less than 30min
and radiographic sign of gonarthrosis with osteophyte (on X-rays of less than 3 years).
Patient can come to the final visit at 6 months and living within a perimeter of 30km around Dax.
Patient affiliated to a social security scheme.
Exclusion Criteria:
Osteoarthritis limited to patellofemoral joint.
A previous spa therapy of less than 6 months.
Spa therapies with double indication rheumatology and phlebology.
Patient with osteoporosis.
A known hepatocellular failure or known acute or end-stage renal failure.
Severe depressive syndrome, psychotic syndrome, immune deficiency, cardiopathy, evolutive neoplasia or infection.
Infiltration and/or viscosupplementation < 6 months.
Change in anti-osteoarthritis treatment of less than 3 months.
Patient under tutorship or curatorship.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles COWAN, MD
Organizational Affiliation
CH de Dax
Official's Role
Principal Investigator
Facility Information:
Facility Name
centre hospitalier Dax
City
Dax
ZIP/Postal Code
40100
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
19734131
Citation
Forestier R, Desfour H, Tessier JM, Francon A, Foote AM, Genty C, Rolland C, Roques CF, Bosson JL. Spa therapy in the treatment of knee osteoarthritis: a large randomised multicentre trial. Ann Rheum Dis. 2010 Apr;69(4):660-5. doi: 10.1136/ard.2009.113209. Epub 2009 Sep 3.
Results Reference
result
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Follow-up of Osteo-articular Biomarkers After Spa Therapy in a Population With Knee Osteoarthritis and Their Correlation With the Clinical Evolution
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