The Effect of Sympathetic Dysfunction on Muscle Spindle in Fibromyalgia

May 26, 2023 updated by: Tuğba Aydın, Istanbul Physical Medicine Rehabilitation Training and Research Hospital

The Effect of Sympathetic Dysfunction on Muscle Spindle Activity in Patients With Fibromyalgia Syndrome

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 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

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • İstanbul, Turkey, 34192
        • Tugba Aydin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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)
Mental arithmetic calculation and cold pressure increase sympathetic tone. For the mental arithmetic task, the subject is asked to mentally subtract a two-digit number from a four-digit number and respond within 5 seconds. This arithmetic calculation is repeated for different numbers. This test is continued for three minutes. For the cold pressure test, subjects are asked to immerse their right hand in 2-4 degrees cold water up to the elbow and hold it in the water for three minutes. The mental arithmetic task and cold stress test will be applied simultaneously.
Drug: Pregabalin 150mg
In the second phase of the experiment, 150 mg (single dose) of pregabalin will be given to FMS patients to reduce sympathetic activity and evaluate its effect on T- and H-reflexes.
Other Names:
  • sympathetic block
Other: Healthy control group
The effect of sympathetic tone changes on T- and H-reflexes will be evaluated in healthy cases.
Diagnostic test: sympathetic stimulation maneuver (mental arithmetic test, cold pressure test)
Mental arithmetic calculation and cold pressure increase sympathetic tone. For the mental arithmetic task, the subject is asked to mentally subtract a two-digit number from a four-digit number and respond within 5 seconds. This arithmetic calculation is repeated for different numbers. This test is continued for three minutes. For the cold pressure test, subjects are asked to immerse their right hand in 2-4 degrees cold water up to the elbow and hold it in the water for three minutes. The mental arithmetic task and cold stress test will be applied simultaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in T-reflex amplitude after intervention
Time Frame: immediately after the intervention
In order to elicit the right soleus T-reflex, a constant-intensity strike will be made on the Achilles tendon with a reflex hammer at intervals of 10-15 seconds. An accelerometer will be placed over the Achilles tendon to measure T-reflex latency and confirm that strike intensities are constant. Recordings will be taken from the right soleus muscle. T-reflex peak-to-peak amplitudes will be measured in electromyographic recordings.
immediately after the intervention
Change from baseline in H-reflex amplitude after intervention
Time Frame: immediately after the intervention
The right tibial nerve will be stimulated with a monopolar technique from the popliteal region to elicit the soleus H-reflex response. The stimulation electrode (cathode) will be placed on the tibial nerve in the popliteal fossa and the anode will be placed on the prepatellar region. For stimulation, a 1ms monophasic square wave pulse current will be given. Mmax will be determined firstly.The current intensity providing a 10% Mmax response will be used to test the H-reflex response. H-reflex peak-to-peak amplitude will be measured in electromyographic recordings.
immediately after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate variability
Time Frame: immediately after the intervention
Sympathetic tone will be evaluated by measuring heart rate variability in the ECG recording taken from the DII lead.
immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Investigators

  • Principal Investigator: TUGBA AYDIN, İstanbul Physical Therapy Rehabilitation Training & Research Hosptial

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 2, 2023

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

January 7, 2023

First Submitted That Met QC Criteria

January 20, 2023

First Posted (Actual)

January 30, 2023

Study Record Updates

Last Update Posted (Actual)

May 30, 2023

Last Update Submitted That Met QC Criteria

May 26, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstanbulPMRTRH-Fibromyalgia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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