Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:45 AM
Study NCT ID:
NCT06841302
Status:
COMPLETED
Last Update Posted:
2025-02-24
First Post:
2025-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Alexithymia Levels in Fibromyalgia
Sponsor:
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Organization:
Study Overview
Official Title:
Investigation of Alexithymia Levels in Fibromyalgia Syndrome Before and After Treatment
Status:
COMPLETED
Status Verified Date:
2025-02
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:
The primary aim of this study was to investigate the changes in alexithymia levels in fibromyalgia patients over a six-month period following a combined treatment and to assess the relationship between changes in fibromyalgia symptom severity and changes in alexithymia levels. Specifically, the study sought to determine if improvements in fibromyalgia symptoms, as measured by the Visual Analog Scale (VAS), were associated with reductions in alexithymia, as measured by the Toronto Alexithymia Scale-20 (TAS-20).
Detailed Description:
Background and Objectives: Fibromyalgia (FM) is a chronic pain condition characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, and cognitive difficulties. FM affects approximately 0.2-6.6% of the world's population and is more frequent in women. It is known that psychiatric comorbidities are frequently observed in individuals with fibromyalgia (FM). In this context, while depression/major depressive disorder (MDD) stands out as the most commonly encountered psychiatric disorder among individuals diagnosed with FM, bipolar disorder, panic disorder, post-traumatic stress disorder (PTSD), and less frequently, anxiety disorders are also observed. The presence of these comorbidities can affect the clinical course and treatment response of FM, therefore, it is important to consider this condition in the evaluation of FM patients and in the development of treatment plans.
Alexithymia, characterized by difficulty identifying and describing feelings and a preference for external thinking, potentially leading individuals to report somatic symptoms like pain rather than emotional experiences. Alexithymia is more prevalent in individuals with fibromyalgia and it correlates with both distress and pain intensity. This study investigates whether successful SSRI treatment in fibromyalgia patients correlates with improved alexithymia levels, exploring the potential link between treatment response and enhanced emotional processing.
Methods:This prospective observational cohort study was conducted at Istanbul Physical Medicine and Rehabilitation Training and Research Hospital. Patients diagnosed with fibromyalgia syndrome (FMS) according to American College of Rheumatology criteria were included. Those with psychiatric disorders, neurological conditions causing alexithymia, or under antidepressant treatment were excluded. All participants received duloxetine treatment combined with an aerobic exercise program. Fibromyalgia symptoms were assessed using Visual Analog Scale (VAS) at baseline and 6 months, while alexithymia was evaluated using Toronto Alexithymia Scale-20 (TAS) at baseline, 3, and 6 months. Statistical analysis included repeated measures ANOVA with Greenhouse-Geisser correction, paired t-tests, and correlation analyses, with adjustments for age, BMI, and daily medication count.
Alexithymia, characterized by difficulty identifying and describing feelings and a preference for external thinking, potentially leading individuals to report somatic symptoms like pain rather than emotional experiences. Alexithymia is more prevalent in individuals with fibromyalgia and it correlates with both distress and pain intensity. This study investigates whether successful SSRI treatment in fibromyalgia patients correlates with improved alexithymia levels, exploring the potential link between treatment response and enhanced emotional processing.
Methods:This prospective observational cohort study was conducted at Istanbul Physical Medicine and Rehabilitation Training and Research Hospital. Patients diagnosed with fibromyalgia syndrome (FMS) according to American College of Rheumatology criteria were included. Those with psychiatric disorders, neurological conditions causing alexithymia, or under antidepressant treatment were excluded. All participants received duloxetine treatment combined with an aerobic exercise program. Fibromyalgia symptoms were assessed using Visual Analog Scale (VAS) at baseline and 6 months, while alexithymia was evaluated using Toronto Alexithymia Scale-20 (TAS) at baseline, 3, and 6 months. Statistical analysis included repeated measures ANOVA with Greenhouse-Geisser correction, paired t-tests, and correlation analyses, with adjustments for age, BMI, and daily medication count.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: