Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04845737 |
Other study ID # |
AIBU-FTR-EY-03 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
June 7, 2021 |
Est. completion date |
August 20, 2022 |
Study information
Verified date |
October 2022 |
Source |
Abant Izzet Baysal University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Fibromyalgia Syndrome (FMS); It is a chronic condition characterized by widespread body pain,
sleep disturbance, fatigue, impaired cognitive functions, and anxiety (1). FMS; chronic
fatigue syndrome, interstitial cystitis, irritable bowel syndrome, temperomandibular joint
dysfunction, myofascial pain, functional dyspepsia, restless leg syndrome and posttraumatic
stress disorder are among central sensitization syndromes (2,3).
Description:
Etiology and pathogenesis in fibromyalgia have not been fully elucidated. Many mechanisms
contribute to the formation of FMS. Many evidence has been found for dysfunction of the
central and autonomic nervous system, immune system, cytokines, neurotransmitters and
hormones, which are thought to play a role in the disease.
Since increasing systemic inflammation is thought to have a role in the etiopathogenesis of
FMS, there are increasing numbers of studies focusing on this aspect of fibromyalgia.
Neutrophil / lymphocyte ratio (NLR) and platelet / lymphocyte ratio (PLR) in peripheral blood
are simple markers of systemic inflammatory response.
Another factor thought to have a role in etiopathogenesis is autonomic nervous system
dysfunction. It has been found that there is autonomic dysfunction in the sympathetic nervous
system in patients with FMS. Sympathetic skin response measurements are frequently used
electrophysiological methods to evaluate the functionality of the sympathetic nervous system,
which is a component of the autonomic nervous system.
In addition, vitamin D deficiency is common in FMS patients. In a study, inadequate vitamin D
levels were found in 45% of fibromyalgia patients.
When a literature review is performed, it is seen that electrophysiological studies are
performed to evaluate autonomic dysfunction in patients with fibromyalgia. No studies were
found showing the relationship between vitamin D levels and inflammatory parameters in
patients with fibromyalgia and electrophysiological findings. In our study, it was aimed to
compare the autonomic dysfunction of fibromyalgia patients with healthy volunteers by
electrophysiological evaluation and to investigate the relationship between vitamin D levels
and inflammatory parameters in fibromyalgia patients and the data obtained from
electrophysiological studies. In this way, we aimed to contribute to a better understanding
of the physiopathology of fibromyalgia patients with autonomic dysfunction.