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

NCT04308369 | Completed

• 1 other identifier: 2019-A02801-56
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Knee osteoarthritis; spa therapy; osteo-articular markers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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)

• Index of symptomatic severity of knee osteoarthritis or WOMAC

  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)

Study Arms (1)

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).

Biological: Blood collection arm

Interventions

Blood collection arm BIOLOGICAL

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.

Blood collection arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ch Mont de Marsan: lead

Study Sites (1)

centre hospitalier Dax

Dax, 40100, France

Location

Related 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. Epub 2009 Sep 3.

  PMID: 19734131 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Charles COWAN, MD

  CH de Dax

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: interventional study with minimal risk. Ony blood collection done during study to determinate biological marker level

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 16, 2020
• Study Start: September 15, 2020
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-06

Locations

FR (1)