Knee OsteoarthritisBIOMARTHROSENCT04308369
Follow-up of Osteo-articular Biomarkers After Spa Therapy in a Population With Knee Osteoarthritis and Their Correlation With the Clinical Evolution
A study testing Blood collection arm in people with Knee Osteoarthritis, run by CHI MONT DE MARSAN ET PAYS DES SOURCES at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Blood collection arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2020to 30 Jun 2023
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Infiltration and/or viscosupplementation < 6 months.
- Change in anti-osteoarthritis treatment of less than 3 months.
- Patient under tutorship or curatorship.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Blood collection arm
- Keywords
- Knee osteoarthritis, spa therapy, osteo-articular markers
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collection armBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Blood collection arm | Other | 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). Receives: Biological: Blood collection arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months (timepoint: at Day 0, Week 3 and month 6)
Secondary outcomes (6)
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).
Measured: 6 months (timepoint: at Day 0, Week 3 and month 6)
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).
Measured: 6 months (timepoint: at Day 0, Week 3 and month 6)
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.
Measured: 6 months (timepoint: at Day 0, Week 3 and month 6)
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.
Measured: 6 months (timepoint: at Day 0, Week 3 and month 6)
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.
Measured: 6 months (timepoint: at Day 0, Week 3 and month 6)
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).
Measured: 6 months (timepoint: at Day 0, Week 3 and month 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start15 Sep 2020
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- interventional study with minimal risk. Ony blood collection done during study to determinate biological marker level
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHI MONT DE MARSAN ET PAYS DES SOURCES
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles COWAN, MD, Principal investigator, CH de Dax
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04308369
- Sponsor's protocol ID
- 2019-A02801-56
- Acronym
- BIOMARTHROSE
- Status last verified
- Jun 2023
- First submitted
- 5 Mar 2020
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 19734131
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04308369
- Acronym / sponsor ID
- BIOMARTHROSE / 2019-A02801-56
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee osteoarthritis, spa therapy, osteo-articular markers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- CHI MONT DE MARSAN ET PAYS DES SOURCESUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 16 Mar 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- interventional study with minimal risk. Ony blood collection done during study to determinate biological marker level
| Arm | Type | Receives |
|---|---|---|
| Blood collection arm | Other | Biological: Blood collection armBlood collection will be performed before the spa therapy (Day 0), at the end of the spa therapy (Week 3) and 6 months later (M6). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with knee osteoarthritis defined according to the recommendations of the American College of Rheumatology (ACR):
- 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.
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| Blood collection armBlood 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. | Biological | Blood collection arm |
Primary outcome
Describe the change of serum level of Hyaluronic acid (a marker of synovial inflammation)
Time frame: 6 months (timepoint: at Day 0, Week 3 and month 6)
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).
6 secondary outcomes
Marker of cartilage degradation: Coll2-1
Time frame: 6 months (timepoint: at Day 0, Week 3 and month 6)
Marker of bone resorption: CTX1
Time frame: 6 months (timepoint: at Day 0, Week 3 and month 6)
Index of symptomatic severity of knee osteoarthritis or WOMAC
Time frame: 6 months (timepoint: at Day 0, Week 3 and month 6)
Pain evaluation Visual Analogue Scale
Time frame: 6 months (timepoint: at Day 0, Week 3 and month 6)
SF 36 Quality of Life Questionnaire
Time frame: 6 months (timepoint: at Day 0, Week 3 and month 6)
Global clinical evaluation with kne flexion and joint swelling
Time frame: 6 months (timepoint: at Day 0, Week 3 and month 6)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Results publication: PubMed 19734131Forestier 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.
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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.
Charles COWAN, MD principal investigator
CH de Dax
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood collection arm in people with Knee Osteoarthritis, run by CHI MONT DE MARSAN ET PAYS DES SOURCES at 1 site in France.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe the change of serum level of Hyaluronic acid (a marker of synovial inflammation) (time frame: 6 months (timepoint: at Day 0, Week 3 and month 6)). 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 NCT04308369, which also lists 1 linked publication.
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 3 Jul 2023.