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

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

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Biological: Blood collection arm

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Dax, France, 40100
    • Centre Hospitalier Dax

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Ch Mont de Marsan
• Investigators: Principal Investigator: Charles COWAN, MD, CH de Dax

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: March 5, 2020
• First Submitted That Met QC Criteria: March 11, 2020
• First Posted (Actual): March 16, 2020

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 30, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Knee osteoarthritis; spa therapy; osteo-articular markers
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 2019-A02801-56

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No