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Clinical Trials/NCT04308369
NCT04308369
Completed
Not Applicable

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

Ch Mont de Marsan1 site in 1 country37 target enrollmentSeptember 15, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
Ch Mont de Marsan
Enrollment
37
Locations
1
Primary Endpoint
Describe the change of serum level of Hyaluronic acid (a marker of synovial inflammation)
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 15, 2020
End Date
June 30, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Ch Mont de Marsan
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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).

Secondary Outcomes

  • Index of symptomatic severity of knee osteoarthritis or WOMAC(6 months (timepoint: at Day 0, Week 3 and month 6))
  • Marker of cartilage degradation: Coll2-1(6 months (timepoint: at Day 0, Week 3 and month 6))
  • Marker of bone resorption: CTX1(6 months (timepoint: at Day 0, Week 3 and month 6))
  • Pain evaluation Visual Analogue Scale(6 months (timepoint: at Day 0, Week 3 and month 6))
  • SF 36 Quality of Life Questionnaire(6 months (timepoint: at Day 0, Week 3 and month 6))
  • Global clinical evaluation with kne flexion and joint swelling(6 months (timepoint: at Day 0, Week 3 and month 6))

Study Sites (1)

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