search
Back to results

The Effect of Sympathetic Dysfunction on Muscle Spindle in Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
sympathetic stimulation maneuver (mental arithmetic test, cold pressure test)
Pregabalin 150mg
Sponsored by
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Fibromyalgia focused on measuring fibromyalgia

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleAccepts 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

Sites / Locations

  • Tugba Aydin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Fibromyalgia group

Healthy control group

Arm 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.

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

Outcomes

Primary Outcome Measures

Change from baseline in T-reflex amplitude after 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.
Change from baseline in H-reflex amplitude after 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.

Secondary Outcome Measures

Heart rate variability
Sympathetic tone will be evaluated by measuring heart rate variability in the ECG recording taken from the DII lead.

Full Information

First Posted
January 7, 2023
Last Updated
May 26, 2023
Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05704374
Brief Title
The Effect of Sympathetic Dysfunction on Muscle Spindle in Fibromyalgia
Official Title
The Effect of Sympathetic Dysfunction on Muscle Spindle Activity in Patients With Fibromyalgia Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2, 2023 (Anticipated)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
fibromyalgia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
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.
Allocation
Non-Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fibromyalgia group
Arm Type
Experimental
Arm 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.
Arm Title
Healthy control group
Arm Type
Other
Arm Description
The effect of sympathetic tone changes on T- and H-reflexes will be evaluated in healthy cases.
Intervention Type
Diagnostic Test
Intervention Name(s)
sympathetic stimulation maneuver (mental arithmetic test, cold pressure test)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Pregabalin 150mg
Other Intervention Name(s)
sympathetic block
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in T-reflex amplitude after intervention
Description
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.
Time Frame
immediately after the intervention
Title
Change from baseline in H-reflex amplitude after intervention
Description
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.
Time Frame
immediately after the intervention
Secondary Outcome Measure Information:
Title
Heart rate variability
Description
Sympathetic tone will be evaluated by measuring heart rate variability in the ECG recording taken from the DII lead.
Time Frame
immediately after the intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
TUGBA AYDIN, Assoc Prof
Phone
+905324622162
Email
drtugbaaydin@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
ILHAN KARACAN, Prof
Phone
+905327005361
Email
ilhankaracan@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
TUGBA AYDIN
Organizational Affiliation
İstanbul Physical Therapy Rehabilitation Training & Research Hosptial
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tugba Aydin
City
İstanbul
ZIP/Postal Code
34192
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32120395
Citation
Bair MJ, Krebs EE. Fibromyalgia. Ann Intern Med. 2020 Mar 3;172(5):ITC33-ITC48. doi: 10.7326/AITC202003030.
Results Reference
background
PubMed Identifier
33454042
Citation
Aguilar-Ferrandiz ME, Casas-Barragan A, Tapia-Haro RM, Rus A, Molina F, Correa-Rodriguez M. Evaluation of sympathetic adrenergic branch of cutaneous neural control throughout thermography and its relationship to nitric oxide levels in patients with fibromyalgia. J Therm Biol. 2021 Jan;95:102813. doi: 10.1016/j.jtherbio.2020.102813. Epub 2020 Dec 14.
Results Reference
background
PubMed Identifier
33119628
Citation
Reyes Del Paso GA, de la Coba P. Reduced activity, reactivity and functionality of the sympathetic nervous system in fibromyalgia: An electrodermal study. PLoS One. 2020 Oct 29;15(10):e0241154. doi: 10.1371/journal.pone.0241154. eCollection 2020. Erratum In: PLoS One. 2020 Dec 28;15(12):e0244830.
Results Reference
background
PubMed Identifier
25994126
Citation
Radovanovic D, Peikert K, Lindstrom M, Domellof FP. Sympathetic innervation of human muscle spindles. J Anat. 2015 Jun;226(6):542-8. doi: 10.1111/joa.12309.
Results Reference
background
PubMed Identifier
19101166
Citation
Kamibayashi K, Nakazawa K, Ogata H, Obata H, Akai M, Shinohara M. Invariable H-reflex and sustained facilitation of stretch reflex with heightened sympathetic outflow. J Electromyogr Kinesiol. 2009 Dec;19(6):1053-60. doi: 10.1016/j.jelekin.2008.11.002. Epub 2008 Dec 19.
Results Reference
background
PubMed Identifier
15542572
Citation
Hjortskov N, Skotte J, Hye-Knudsen C, Fallentin N. Sympathetic outflow enhances the stretch reflex response in the relaxed soleus muscle in humans. J Appl Physiol (1985). 2005 Apr;98(4):1366-70. doi: 10.1152/japplphysiol.00955.2004. Epub 2004 Nov 12.
Results Reference
background
PubMed Identifier
23838093
Citation
Meeus M, Goubert D, De Backer F, Struyf F, Hermans L, Coppieters I, De Wandele I, Da Silva H, Calders P. Heart rate variability in patients with fibromyalgia and patients with chronic fatigue syndrome: a systematic review. Semin Arthritis Rheum. 2013 Oct;43(2):279-87. doi: 10.1016/j.semarthrit.2013.03.004. Epub 2013 Jul 6.
Results Reference
background
PubMed Identifier
19411061
Citation
Light KC, Bragdon EE, Grewen KM, Brownley KA, Girdler SS, Maixner W. Adrenergic dysregulation and pain with and without acute beta-blockade in women with fibromyalgia and temporomandibular disorder. J Pain. 2009 May;10(5):542-52. doi: 10.1016/j.jpain.2008.12.006.
Results Reference
background
PubMed Identifier
27026828
Citation
White AT, Light KC, Bateman L, Hughen RW, Vanhaitsma TA, Light AR. Effect of Pregabalin on Cardiovascular Responses to Exercise and Postexercise Pain and Fatigue in Fibromyalgia: A Randomized, Double-Blind, Crossover Pilot Study. Pain Res Treat. 2015;2015:136409. doi: 10.1155/2015/136409. Epub 2015 Dec 29.
Results Reference
background
PubMed Identifier
20147618
Citation
Bockbrader HN, Radulovic LL, Posvar EL, Strand JC, Alvey CW, Busch JA, Randinitis EJ, Corrigan BW, Haig GM, Boyd RA, Wesche DL. Clinical pharmacokinetics of pregabalin in healthy volunteers. J Clin Pharmacol. 2010 Aug;50(8):941-50. doi: 10.1177/0091270009352087. Epub 2010 Feb 10.
Results Reference
background

Learn more about this trial

The Effect of Sympathetic Dysfunction on Muscle Spindle in Fibromyalgia

We'll reach out to this number within 24 hrs