Clinical trial NCT04308369: Follow-up of Osteo-articular Biomarkers After Spa Therapy in a Population With Knee Osteoarthritis and Their Correlation With the Clinical Evolution
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
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Knee osteoarthritis
spa therapy
osteo-articular markers
Lead sponsor: Ch Mont de Marsan
Sponsor class: OTHER
First posted: 2020-03-16
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: interventional study with minimal risk. Ony blood collection done during study to determinate biological marker level
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Describe the change of serum level of Hyaluronic acid (a marker of synovial inflammation)
timeFrame: 6 months (timepoint: at Day 0, Week 3 and month 6)
Secondary outcomes:
measure: Marker of cartilage degradation: Coll2-1
timeFrame: 6 months (timepoint: at Day 0, Week 3 and month 6)
measure: Marker of bone resorption: CTX1
timeFrame: 6 months (timepoint: at Day 0, Week 3 and month 6)
measure: Index of symptomatic severity of knee osteoarthritis or WOMAC
timeFrame: 6 months (timepoint: at Day 0, Week 3 and month 6)
measure: Pain evaluation Visual Analogue Scale
timeFrame: 6 months (timepoint: at Day 0, Week 3 and month 6)
measure: SF 36 Quality of Life Questionnaire
timeFrame: 6 months (timepoint: at Day 0, Week 3 and month 6)
measure: Global clinical evaluation with kne flexion and joint swelling
timeFrame: 6 months (timepoint: at Day 0, Week 3 and month 6)
Other outcomes:
Locations:
city: Dax
country: France
facility: centre hospitalier Dax
Study officials:
affiliation: CH de Dax
name: Charles COWAN, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.