The Effect of Sympathetic Dysfunction on Muscle Spindle in Fibromyalgia

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Status: Not yet enrolling

Conditions: Fibromyalgia

Treatments: Diagnostic Test: sympathetic stimulation maneuver (mental arithmetic test, cold pressure test); Drug: Pregabalin 150mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05704374

IstanbulPMRTRH-Fibromyalgia

Details and patient eligibility

About

This study aims to reveal whether there is an impairment in the sympathetic regulation of muscle spindle sensitivity in patients with fibromyalgia syndrome (FMS).

Full 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 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.

Enrollment: 36 estimated patients

Sex: Female

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

For the fibromyalgia group

• Patients diagnosed with FMS based on the American college of rheumatology - 2016 criteria
• Between the ages of 20-50
• Being a woman
• Patients prescribed pregabalin for the treatment

For the Healthy Control group

• Between the ages of 20-50
• Being a woman
• Being healthy

Exclusion criteria

• Those with medical problems in the right upper and lower extremities (skin, neuromuscular, joint, vascular pathologies)
• Cases that cannot perform arithmetic operations
• Cold allergy
• Heart disease (arrhythmia, ischemic heart disease, heart failure)
• Hypertension
• Epilepsy

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

36 participants in 2 patient groups

Fibromyalgia group

Experimental group

Description:

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.

Treatment:

Diagnostic Test: sympathetic stimulation maneuver (mental arithmetic test, cold pressure test)

Drug: Pregabalin 150mg

Healthy control group

Other group

Description:

The effect of sympathetic tone changes on T- and H-reflexes will be evaluated in healthy cases.

Treatment:

Diagnostic Test: sympathetic stimulation maneuver (mental arithmetic test, cold pressure test)