Ignite Creation Date:
2024-05-06 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05704374
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-05-30
First Post:
2023-01-07
Brief Title:
The Effect of Sympathetic Dysfunction on Muscle Spindle in Fibromyalgia
Sponsor:
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Organization:
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Study Overview
Official Title:
The Effect of Sympathetic Dysfunction on Muscle Spindle Activity in Patients With Fibromyalgia Syndrome
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-05
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:
This study aims to reveal whether there is an impairment in the sympathetic regulation of muscle spindle sensitivity in patients with fibromyalgia syndrome FMS
Detailed Description:
The common muscle pain and fatigue symptoms of FMS can be explained by impaired sympathetic regulation of muscle spindle sensitivity The aim of this study is to reveal whether there is an impairment in the sympathetic regulation of muscle spindle sensitivity in FMS patients
Material method
In the first stage resting sympathetic tone measurement and resting H-reflex and T-reflex recordings will be taken in all cases Sympathetic tone measurement will be performed and H-reflex and T-reflex recordings will be taken during and after sympathetic stimulation maneuvers mental arithmetic calculation and cold application in FMS patients and healthy control subjects In the second phase the first dose of pregabalin will be given to patients diagnosed with FMS and prescribed pregabalin Pregabalin is known to reduce sympathetic activity in FMS After oral administration of pregabalin its peak plasma concentration is reached in 09-13 hours Therefore 15 hours later sympathetic tone measurement will be made at rest and during the sympathetic stimulation maneuver and H-reflex and T-reflex recordings will be taken Patients in the healthy control group will not be given pregabalin
Material method
In the first stage resting sympathetic tone measurement and resting H-reflex and T-reflex recordings will be taken in all cases Sympathetic tone measurement will be performed and H-reflex and T-reflex recordings will be taken during and after sympathetic stimulation maneuvers mental arithmetic calculation and cold application in FMS patients and healthy control subjects In the second phase the first dose of pregabalin will be given to patients diagnosed with FMS and prescribed pregabalin Pregabalin is known to reduce sympathetic activity in FMS After oral administration of pregabalin its peak plasma concentration is reached in 09-13 hours Therefore 15 hours later sympathetic tone measurement will be made at rest and during the sympathetic stimulation maneuver and H-reflex and T-reflex recordings will be taken Patients in the healthy control group will not be given pregabalin
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