NCT05819437: ANGELLO

Knee Osteoarthritis and Balneotherapy

Completed NA Last updated 19 April 2023

What this trial tests

NA trial testing Balneotherapy program in Knee Osteoarthritis in 173 participants. Completed in 20 September 2022.

Timeline

26 August 2020

Primary endpoint
3 July 2021

20 September 2022

Quick facts

Lead sponsor	CEN Biotech
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	173
Start date	26 August 2020
Primary completion	3 July 2021
Estimated completion	20 September 2022
Sites	1 location across France

Drugs / interventions tested

• Balneotherapy program

Conditions studied

• Knee Osteoarthritis — all drugs for Knee Osteoarthritis →

Sponsor

CEN Biotech — full company profile →

Who can join

Adults 50 to 80, any sex, with Knee Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The effectiveness of a 3-week spa therapy on the 6-month mobility and functional ability of patients with knee osteoarthritis: the ANGELLO randomized controlled trial.
   Forestier R, Debiais F, Michel N, Schueller R, et al · · 2025 · cited 1× · PMID 40358707 · DOI 10.1007/s00484-025-02927-2
2. Efficacy and safety of balneotherapy in rheumatology: a systematic review and meta-analysis.
   Aribi I, Nourredine M, Giroudon C, Massy E, et al · · 2025 · cited 1× · PMID 40010834 · DOI 10.1136/bmjopen-2024-089597