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

NCT ID: NCT04308369

Last Updated: 2023-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-15

Study Completion Date

2023-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

interventional study with minimal risk. Ony blood collection done during study to determinate biological marker level
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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).

Group Type OTHER

Blood collection arm

Intervention Type 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.

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ch Mont de Marsan

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles COWAN, MD

Role: PRINCIPAL_INVESTIGATOR

CH de Dax

Locations

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centre hospitalier Dax

Dax, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 19734131 (View on PubMed)

Other Identifiers

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2019-A02801-56

Identifier Type: -

Identifier Source: org_study_id

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