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OpenTrials
Completed

NCT Number: NCT05819437

Knee Osteoarthritis and Balneotherapy

The goal of this clinical trial is to assess the efficacy of a 18-day balneotherapy program in the rheumatology indication in patients presented with knee osteoarthritis. The main questions of the study aims to answer are how balneotherapy improves functional incapacity and the disorders (pain, joint stiffness) induced by osteoarthritis of the knee, and thus improves patients' quality of life.

Participants are randomly assigned in control or treatment (spa) groups. All receive standard of care for knee osteoarthritis throughout the study. Balneotherapy program consists of 18-days of spa treatment with Mineral Water of Saint Jean d'Angely. Functional incapacity, disorders and quality of life induced were measured at baseline and then 6 months later.

Variation from baseline were compared in control and treatment groups to assess the efficacy of the balneotherapy program.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CEN

Dijon, 21000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Knee osteoarthritis with Kellgren and Lawrence stage 2 to 4 evidenced by a knee X-ray examination in the past 3 years);
  • 100-normalized score of the WOMAC physical function subscale of 30 or greater;
  • Available for balneotherapy program and the 6-month study follow-up;
  • Signed inform consent;
  • with health insurance affiliation.

Exclusion criteria

  • Presented with balneotherapy contra-indication;
  • Having had spa treatment in the past 6 months or intra-articular corticosteroid injection within the previous 90 days or hyaluronic acid infiltration within the previous 6 months;
  • Presented with chronic pain other than osteoarthritis, with scheduled surgery related to knee osteoarthritis;
  • regulatory reason (guardianship or already enrolled in a clinical trial).

Treatment and study plan

Balneotherapy program

Other

Whirlpool bath, bath with immersion showers, poultice application and underwater massage.

The baths were performed in an individual tub in ten-minute sessions. The temperature was set specifically for each patient, on average from 34 to 38°C. These were baths with jets and air diffusion.

The mud was applied as a poultice to the 2 knees and if necessary (duration of application: 10 minutes).

The massages were carried out by qualified physiotherapists under an affusion ramp of thermal water at 38°C for 10 minutes.

The water used is a mixed sulphated Natural Mineral Water, collected by drilling the "capuchins" at a depth of 975 m. The temperature of the water at the outlet of the borehole is 41.8°C and is lowered to 35°C.

Primary outcomes

  1. Variation from baseline in physical function subscale of the WOMAC at 6 months

    Time frame: Baseline (D1) and final (6 months)

    Physical function subscale of the Western Ontario and McMaster Universities Arthritis Index (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).

Secondary outcomes

  1. Variation from baseline in physical function subscale of the WOMAC at 3 months

    Time frame: Baseline (D1) and final (3 months)

    Physical function subscale of the Western Ontario and McMaster Universities Arthritis Index (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).

  2. Variation from baseline in pain subscale of the WOMAC at 3 months

    Time frame: Baseline (D1) and final (3 months)

    Pain subscale of the WOMAC is a self-administered questionnaire that consists in 5 items: during walking, using stairs, in bed, sitting or lying, and standing upright. The 100-normalized subscale score ranges from 0 (none) to 100 (worse pain limitations).

  3. Variation from baseline in pain subscale of the WOMAC at 6 months

    Time frame: Baseline (D1) and final (6 months)

    Pain subscale of the WOMAC is a self-administered questionnaire that consists in 5 items: during walking, using stairs, in bed, sitting or lying, and standing upright. The 100-normalized subscale score ranges from 0 (none) to 100 (worse pain limitations).

  4. Variation from baseline in stiffness subscale of the WOMAC at 3 months

    Time frame: Baseline (D1) and final (3 months)

    Stiffness subscale of the WOMAC is a self-administered questionnaire that consists in 2 items: during walking, using stairs, in bed, sitting or lying, and standing upright. The 100-normalized subscale score ranges from 0 (none) to 100 (worse stiffness limitations).

  5. Variation from baseline in stiffness subscale of the WOMAC at 6 months

    Time frame: Baseline (D1) and final (6 months)

    Stiffness subscale of the WOMAC is a self-administered questionnaire that consists in 2 items: during walking, using stairs, in bed, sitting or lying, and standing upright. The 100-normalized subscale score ranges from 0 (none) to 100 (worse stiffness limitations).

  6. Variation from baseline in WOMAC total score at 3 months

    Time frame: Baseline (D1) and final (3 months)

    The scores for each subscale are summed up to calculate the total WOMAC score. The 100-normalized score ranges from 0 (none) to 100 (worse limitations).

  7. Variation from baseline in WOMAC total score at 6 months

    Time frame: Baseline (D1) and final (6 months)

    The scores for each subscale are summed up to calculate the total WOMAC score. The 100-normalized score ranges from 0 (none) to 100 (worse limitations).

  8. Variation from baseline in pain-induced knee osteoarthritis intensity at 3 months

    Time frame: Baseline (D1) and final (3 months)

    Pain intensity is measured using a 0 (no pain)-100 (Worse pain) Visual Analogic Scale (VAS).

  9. Variation from baseline in pain-induced knee osteoarthritis intensity at 6 months

    Time frame: Baseline (D1) and final (6 months)

    Pain intensity is measured using a 0 (no pain)-100 (Worse pain) Visual Analogic Scale (VAS).

  10. Number of participants achieving minimal clinically important improvement (MCII) at 3 months

    Time frame: 3 months

    MCII is defined as 19.9 mm or greater on the VAS pain scale and/or 9.1 points or greater on the WOMAC physical function subscale normalized to a 0-100 score, and no knee surgery

  11. Number of participants achieving minimal clinically important improvement (MCII) at 6 months

    Time frame: 6 months

    MCII is defined as 19.9 mm or greater on the VAS pain scale and/or 9.1 points or greater on the WOMAC physical function subscale normalized to a 0-100 score, and no knee surgery

  12. Number of participants presented with acceptable symptom state (ASS) at 3 months

    Time frame: 3 months

    ASS is defined as VAS pain 32 mm or less or WOMAC function subscale normalized to a 0-100 score of 31 points or less.

  13. Number of participants presented with acceptable symptom state (ASS) at 6 months

    Time frame: 6 months

    ASS is defined as VAS pain 32 mm or less or WOMAC function subscale normalized to a 0-100 score of 31 points or less.

  14. Changes in participants quality of life at 3 months

    Time frame: 3 months

    Quality of life is measured using EUROQOL (EQ-5D-3L) questionnaire.The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

  15. Changes in participants quality of life at 6 months

    Time frame: 6 months

    Quality of life is measured using EUROQOL (EQ-5D-3L) questionnaire.The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

  16. Frequency of adverse events throughout the study

    Time frame: From inclusion to the final visit at 6 months

    Adverse events are described using MedDRA and each event frequency is calculated.

  17. Participants' opinion with their symptoms related to knee osteoarthritis at 6 months

    Time frame: 6 months

    Opinion is measured using a 5-point Likert scale

Sponsors and collaborators

Lead sponsor

CEN Biotech

Industry

Collaborators

  • COMPAGNIE EUROPEENNE DES BAINS

Registry information

Official study title

Effectiveness of a 3-week Balneotherapy Program With Mineral Water of Saint Jean d'Angely in Knee Osteoarthritis: A Superiority, Randomised, Controlled Study Versus Standard of Care Alone

Acronym: ANGELLO

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Apr 19, 2023
Registry last updated
Apr 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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