Benefits of Spa Therapy in Saint-Lary Soulan for Knee Osteoarthritis (LARYTHERM)

University of Bordeaux

Status: Completed

Conditions: Knee Osteoarthritis

Treatments: Other: Spa therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05790824

2021-A02899-32

74119 (Other Identifier)

Details and patient eligibility

About

The hypothesis is that the use of spa therapy in Saint-Lary Soulan for knee osteoarthritis treatment would have a therapeutic effect on this pathology.

The main objective of this external comparison study is to evaluate the comparative effectiveness at 6 months of spa therapy in the Saint-Lary Soulan spa center on functional disability and pain (MCII: Minimal Clinical Important Improvement) in knee osteoarthritis compared to the control group of the Thermarthrose multicenter randomized clinical trial, receiving standard cares.

The patients included in the Larytherm cohort will undergo a three-week spa therapy in Saint-Lary Soulan with a follow-up of 6 months after the end of spa therapy.

Full description

Knee osteoarthritis is a frequent disease with important consequences for quality of life of patients. In France, prevalence was estimated at 7.6% among subjects between 40-75 years old. The management of knee osteoarthritis is essentially based on lifestyle and dietary measures and the use of analgesic treatment. Spa treatments are also part of the overall management of this pathology.

In this context, the spa town Saint-Lary Soulan requests the approval of the " Rheumatology " therapeutic orientation for its new borehole water (SL5), which requires a study (Larytherm) conducted according to the criteria of the French Academy of Medicine.

Secondary objectives are to evaluate 6 months after spa therapy in Saint-Lary Soulan, the evolution of:

• Body Mass Index (BMI),
• knee pain due to knee osteoarthritis,
• functional impact,
• fatigue,
• physical activity,
• quality of life,
• consumption of analgesic treatments,
• the occurrence of episodes of joint effusion requiring puncture/infiltration,
• the occurrence of adverse events.

The patients will be identified by local physicians or through a local public communication campaign. The patients with criteria of eligibility will complete a self-reported questionnaire before the beginning of spa therapy, after the spa therapy and 6 months after the end of spa therapy, and the physicians practising at the spa center will complete a medical questionnaire at inclusion and after the spa therapy.

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• painful knee due to knee osteoarthritis diagnosed for more than 6 months (confirmed by the general practitioner responsible for the identification of the patient) with at least three of the six clinical criteria defined by the American College of Rheumatology:

  • age > 50 years
  • morning stiffness lasting < 30 minutes
  • articular crepitation when moving the knee
  • globular knee with bony hypertrophy on physical examination
  • periarticular bone pain on physical examination
  • absence of local heat on palpation

• Visual Analogue Scale for the evaluation of pain felt over the last eight days with a score greater than or equal to 3/10

• affiliated or benefiting from a Social Security plan

• agreeing to participate in the study, having completed and signed the Patient's Free and Informed Consent Form

Exclusion criteria

• knee osteoarthritis limited to the patello-femoral joint

• at least one of the following diseases/conditions:

  • Contra-indications for the realization of spa therapy: evolving cancer, dementia, severe dermatosis, infectious state not stabilized, pregnancy, severe cardiac and respiratory insufficiency, phlebitis, inflammatory rheumatism, psychosis, acute spinal pain
  • Acute arthritis of septic or inflammatory origin

• an index knee arthroplasty within the last 6 months or a planned arthroplasty on the index knee within the next 6 months

• corticosteroids infiltration or viscosupplementation within the last 3 months

• spa therapy within the previous 6 months

• link with the staff of the Saint-Lary Soulan spa center or the physicians participating in the study (family, employee, etc.)

• language barrier (unable to read the information letter, complete the patient agreement form or self-questionnaires)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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88 participants in 1 patient group

Spa therapy

Experimental group

Description:

Protocol of spa therapy in rheumatology for 3 weeks

Treatment:

Other: Spa therapy