Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06617975
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
Knee Osteoarthritis and Spa Therapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Effectiveness of the Spa Therapy Program for Rheumatology At Santenay in Patients with Knee Osteoarthritis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SANTIAGO
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 patients39 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 ie 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
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 ie 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
Detailed Description:
For study purposes two medical visits with the investigator are organized the first in the 28 days preceding the 18-day balneotherapy program or at the latest on the first day of the program before the first care and the second 6 months after the start of the program A remote visit at 3 months is also organized
The data required for study evaluations are collected by the investigator or self-evaluated by patients during the visits
Patients of the study receive the same exercise recommendations than the patients of the Control group of the reference study and their body weight as well as physical ability are monitored
The data required for study evaluations are collected by the investigator or self-evaluated by patients during the visits
Patients of the study receive the same exercise recommendations than the patients of the Control group of the reference study and their body weight as well as physical ability are monitored
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None