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

Ch Mont de Marsan

Status: Completed

Conditions: Knee Osteoarthritis

Treatments: Biological: Blood collection arm

Study type: Interventional

Funder types: Other

Identifiers

NCT04308369

2019-A02801-56

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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37 participants in 1 patient group

Blood collection arm

Other group

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).

Treatment:

Biological: Blood collection arm