Ignite Creation Date:
2024-05-06 @ 6:50 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05801497
Status:
RECRUITING
Last Update Posted:
2023-04-06
First Post:
2023-03-22
Brief Title:
Balneotherapy in Primary Fibromyalgia
Sponsor:
University of Siena
Organization:
University of Siena
Study Overview
Official Title:
Balneotherapy in Primary Fibromyalgia Impact on Algo-functional Indexes Quality of Life and Anxio-depressive Symptoms
Status:
RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Balneotherapy BT is recommended as non-pharmacological treatment for Fibromyalgia Syndrome FS BT efficacy is based on beneficial properties of both mud bath and stay in a spa environment The main aim of this multicentric prospective longitudinal cohort study is to evaluate BT effectiveness in patients withFS All FS patients with a stable treatment in the past month and a Fibromyalgia Impact Questionnaire FIQ score 39 will be enrolled after providing written informed consent Patients will be divided into two groups based on whether or not BT is added to usual therapy BT Group and Control Group Each patients will be assessed at baseline after 15 and 45 days in BT Group and at baseline and after 15 days in Control group with an assessment of pain by Visual Analogue Scale FIQ Short-Form Health Survey State-Trait Anxiety Inventory STAI and Center for Epidemiologic Studies Depression Scale CES-D Collected data will provide a new insight of BT role and the removal of daily stress in FS management
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None