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

NCT05790824 | Completed DMC

• 2 other identifiers: 2021-A02899-3274119
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthritis

Keywords

pain; spa therapy; functional disability

Outcome Measures

Primary Outcomes (1)

• Number of patients with Minimal Clinically Important Improvement (MCII)

  Improvement from baseline of at least 9.1 points on the Western Ontario and McMaster University osteoarthritis (WOMAC) index standardized functional subscale of 0-100 and/or at least 1.99 cm on the Visual Analogue Scale (VAS) for pain without knee surgery, at 6 months. WOMAC index (functional subscale): functional assessment index for knee osteoarthritis, exploring the daily function. The scoring system used for the answers to the questions is the Lickert scale with 5 possible answers (none = 0; minimal = 1; moderate = 2; severe = 3; extreme = 4). Visual Analogue Scale for the evaluation of knee osteoarthritis-related pain for the index knee experienced over the last eight days. The scale is presented as a 10 cm horizontal line, the left end (= 0 cm) corresponding to no pain and the right end (= 10 cm) to the maximum imaginable pain. This outcome will be evaluated in the Larytherm cohort and compared to the control group of the Thermarthrose study.

  6 months after the end of spa therapy

Secondary Outcomes (12)

• Relative change from baseline in the WOMAC functional subscale index at the end of the spa therapy and at 6 months after the end of the spa therapy.

  Baseline, end of spa therapy (week 3) and 6 months after the end of spa therapy

• Relative change from baseline in the WOMAC index (full questionnaire) at the end of the spa therapy and at 6 months after the end of the spa therapy.

  Baseline, end of spa therapy (week 3) and 6 months after the end of spa therapy

• Relative change from baseline in the knee osteoarthritis pain measured by the Visual Analogue Scale (VAS) for pain at the end of the spa therapy and at 6 months after the end of the spa therapy.

  Baseline, end of spa therapy (week 3) and 6 months after the end of the spa therapy

• Relative change from baseline in fatigue measured by the Visual Analogue Scale (VAS) for fatigue at the end of the spa therapy and at 6 months after the end of the spa therapy.

  Baseline, end of spa therapy (week 3) and 6 months after the end of spa therapy

• Relative change from baseline in Lequesne's algo-functional index at the end of the spa therapy and at 6 months after the end of the spa therapy.

  Baseline, end of spa therapy (week 3) and 6 months after the end of spa therapy

Study Arms (1)

Spa therapy

EXPERIMENTAL

Protocol of spa therapy in rheumatology for 3 weeks

Other: Spa therapy

Interventions

Spa therapy OTHER

The "RH2" rheumatology treatment protocol will propose treatments that can be carried out with water from the SL5 borehole and will be composed of: * 54 treatments among the following treatments: * Swimming pool, 15 minutes (code 201) * Bath with aerobath, 10 minutes (code 205) * Bath with immersion shower, 10 minutes (code 206) * Cataplasm in multiple local application, 10 minutes (code 408) * 18 sessions of mobilization pool, 15 minutes (code 601)

Spa therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Bordeaux: lead

Study Sites (1)

Centre thermal de Saint-Lary Soulan

Saint-Lary-Soulan, 65170, 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; Pain

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrick Blin

  Bordeaux PharmacoEpi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: External comparison study between Larytherm cohort patients and Thermarthrose control patients

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 30, 2023
• Study Start: May 1, 2023
• Primary Completion: January 12, 2024
• Study Completion: January 12, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Locations

FR (1)