Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Tuğba Aydin
This study aims to reveal whether there is an impairment in the sympathetic regulation of muscle spindle sensitivity in patients with fibromyalgia syndrome (FMS).
Fibromyalgia
sympathetic stimulation maneuver (mental arithmetic test, cold pressure test)
Pregabalin 150mg
Not Applicable
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 0.9-1.3 hours. Therefore, 1.5 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 Type : | Interventional |
| Estimated Enrollment : | 36 participants |
| Masking : | Single |
| Masking Description : | In order to ensure that the researcher who took the recordings is blind, sympathetic tone measurement will be made at rest and during the sympathetic stimulation maneuver in healthy subjects 1.5 hours later, and H-reflex and T-reflex recordings will be taken. |
| Primary Purpose : | Basic Science |
| Official Title : | The Effect of Sympathetic Dysfunction on Muscle Spindle Activity in Patients With Fibromyalgia Syndrome |
| Actual Study Start Date : | November 2, 2023 |
| Estimated Primary Completion Date : | December 1, 2023 |
| Estimated Study Completion Date : | December 1, 2023 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Fibromyalgia group In the first phase of the experiment, the effect of sympathetic tone change on T- and H-reflexes will be evaluated. In the second phase of the experiment, 150 mg (single dose) of pregabalin will be given to these patients to reduce sympathetic activity and evaluate its effect on T- and H-reflexes. |
Diagnostic Test: sympathetic stimulation maneuver (mental arithmetic test, cold pressure test) |
|
Other: Healthy control group The effect of sympathetic tone changes on T- and H-reflexes will be evaluated in healthy cases. |
Drug: Pregabalin 150mg |
| Ages Eligible for Study: | 20 Years to 50 Years |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Tugba Aydin
İstanbul, Turkey, 34192