Follow-up of Osteo-articular Biomarkers After Spa Therapy in a Population With Knee Osteoarthritis and Their Correlation With the Clinical Evolution

Knee Osteoarthritis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04308369
• Other study ID #: 2019-A02801-56
• Status: Completed
• Phase: N/A
• Start date: September 15, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: June 2023
• Source: Ch Mont de Marsan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• Blood collection arm
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.

Locations

Country	Name	City	State
France	centre hospitalier Dax	Dax

Sponsors (1)

Lead Sponsor	Collaborator
Ch Mont de Marsan

Country where clinical trial is conducted

France, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	6 months (timepoint: at Day 0, Week 3 and month 6)
Secondary	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).	6 months (timepoint: at Day 0, Week 3 and month 6)
Secondary	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).	6 months (timepoint: at Day 0, Week 3 and month 6)
Secondary	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.	6 months (timepoint: at Day 0, Week 3 and month 6)
Secondary	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.	6 months (timepoint: at Day 0, Week 3 and month 6)
Secondary	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.	6 months (timepoint: at Day 0, Week 3 and month 6)
Secondary	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).	6 months (timepoint: at Day 0, Week 3 and month 6)