Knee Osteoarthritis and Spa Therapy

NCT06617975 | Recruiting DMC

• 1 other identifier: C1729
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this clinical trial is to assess the efficacy of the 18-day balneotherapy program (therapeutic indication: Rheumatology) in terms of functional incapacity and the disorders (pain, joint stiffness) induced by osteoarthritis of the knee, and thus improves patients\' quality of life, in patients presented with knee osteoarthritis. The French National Academy of Medicine encourages the re-use of RCT data when available. In this context, the current study is designed as a single-arm prospective study with external comparison using the propensity score. The Control group consists of the patients which were allocated to the Control group of reference randomized clinical trial (RCT) "ANGELLO Study" (NCT05819437). These patients received standard care for knee osteoarthritis, i.e., pain management and exercise recommendations. All patients enrolled in the current study benefit of 18-day balneotherapy program (therapeutic indication: Rheumatology) with Mineral Water of Santenay (Burgundy, France), and examination with a practitioner at enrollment and 6 months after the beginning of spa treatment.

Conditions

Knee Osteoarthritis; Knee Osteoarthritis (OA)

Keywords

Balneotherapy; Spa therapy; Rheumatology; Knee osteoarthritis; WOMAC

Outcome Measures

Primary Outcomes (2)

• Minimal Clinically Important Improvement (MCII) at 6 months

  MCII is defined as a pain reduction of 19.9 mm or more on a 0-100 visual analogic scale (VAS), where 0 means no pain and 100 worse pain. The percentage of patients achieving MCII is calculated and compared with that of the control group in the reference RCT (external comparison).

  6 months

• Minimal Clinically Important Improvement (MCII) at 6 months

  MCII is defined as a reduction of 9.1 points or more in the function subscale of the Physical function subscale of the Western Ontario and McMaster Universities Arthritis Index (WOMAC) in absence of knee surgery. WOMAC is a self-administered questionnaire that consists in 17 items: (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties. The 100-normalized subscale score ranges from 0 (none) to 100 (worse functional limitations). The percentage of patients achieving MCII is calculated and compared with that of the control group in the reference RCT (external comparison).

  6 months

Secondary Outcomes (16)

• Change from baseline of pain-related knee osteoarthritis at 3 months

  Day 1 and 3 months

• Change from baseline of pain-related knee osteoarthritis at 6 months

  Day 1 and 6 months

• Change from baseline of the pain subscale of the WOMAC at 3 months

  Day 1 and 3 months

• Change from baseline of the pain subscale of the WOMAC at 6 months

  Day 1 and 6 months

• Changes from baseline of stiffness subscale of the WOMAC at 3 months

  Day 1 and 3 months

Other Outcomes (1)

• Satisfaction with the spa therapy and spa site

  Day 18

Study Arms (1)

Balneotherapy

EXPERIMENTAL

18-day balneotherapy program with Mineral Water of Santenay in addition to standard of care for knee osteoarthritis

Other: Balneotherapy program in rheumatology indication

Interventions

Balneotherapy program in rheumatology indication OTHER

At least 4 balneotherapy sessions per day, 6 days a week during 3 consecutive weeks that may include: 1 whirlpool bath per day, 1 poultice application per day, 1 bath with immersion showers in a pool per day, a local jet shower every other day, a penetrating shower every other day. Alternative treatments may replace penetrating shower or local jet shower, or other care, e.g., collective jet shower or steam bath. 10-minute air diffusion baths are taken in individual tubs at 37°C. Mud is applied 10 minutes as a poultice to both knees (minimum 2 per knee, 52°C), if necessary, to other painful osteoarthritis areas. 10-minute collective pool bathing takes place in a thermal pool equipped with jet stations immersed in water at 32°C. 3-minute local jet shower is applied to the predefined area using thermal water at 37°C. 10-minute penetrating showers are delivered by an affusion ramp on the patient lying down and directed on the area defined, using thermal water at 37°C.

Balneotherapy

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Knee osteoarthritis with Kellgren and Lawrence stage 2 to 4 evidenced by a knee X-ray examination in the past 3 years.
• normalized score of the WOMAC physical function subscale greater than or equal to 30.
• Accepting a prescription for a balneotherapy program in the Rheumatology at Santenay spa as part of the management of their knee osteoarthritis issued by the investigator.
• Signed inform consent.
• With health insurance affiliation.

You may not qualify if:

• Presented with balneotherapy contraindication or to certain adjuvant treatment techniques (balneation, hydrotherapy jets, massage): chronic infectious pathology, active cancer, decompensated cardiac, hepatic or renal insufficiency, "open" leg ulcer, immune deficiency, phlebitis, erysipelas or history of erysipelas, active thrombosis, behavioral disorders, etc.
• Presented with chronic pain for reasons other than osteoarthritis: chronic inflammatory rheumatism (rheumatoid arthritis, ankylosing spondylitis, lupus, psoriatic arthritis) or fibromyalgia.
• Having had spa treatment in the past 6 months whatever the indication or intra-articular corticosteroid injection within the previous 90 days or hyaluronic acid infiltration within the previous 6 months.
• Patient scheduled for knee osteoarthrosis-related surgery within the next 7 months.
• Residing more than 30 kilometers from Santenay at the time of spa treatment. Women of childbearing potential who are not using effective contraception (estrogen/progestin or progestin-only oral, vaginal, transdermal, injectable or subcutaneous) or who plan to discontinue contraception within the next 7 months.
• Likely to be unable to comply with protocol or to attend visits, particularly in view of the duration of the research, or unable to read or understand French.
• Regulatory reason (guardianship or already enrolled in a clinical trial).

Sponsors & Collaborators

• CEN Biotech: lead
• COMPAGNIE EUROPEENNE DES BAINS: collaborator
• VALVITAL Santenay: collaborator

Study Sites (1)

Valvital - Thermes de Santenay

Santenay, Burgundy, 21590, France

RECRUITING

Related Links

• ANGELLO STUDY

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• Bruno COLLOMBIER, MD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine JUHEL, Ph.D

CONTACT

+33380680511; christine.juhel@groupecen.com

Amandine FRY

CONTACT

+33380680513; amandine.fry@groupecen.com

Study Design

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

Model Details: Prospective, single-arm, superiority study with external comparison (control group of a reference RCT)

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: October 1, 2024
• Study Start: October 14, 2024
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-08

Locations

FR (1)