The Effect of Sympathetic Dysfunction on Muscle Spindle in Fibromyalgia
NCT ID: NCT05704374
Last Updated: 2023-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
36 participants
INTERVENTIONAL
2023-11-02
2023-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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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.
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.
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.
Healthy control group
The effect of sympathetic tone changes on T- and H-reflexes will be evaluated in healthy cases.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Cases that cannot perform arithmetic operations
* Cold allergy
* Heart disease (arrhythmia, ischemic heart disease, heart failure)
* Hypertension
* Epilepsy
20 Years
50 Years
FEMALE
Yes
Sponsors
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Istanbul Physical Medicine Rehabilitation Training and Research Hospital
OTHER_GOV
Responsible Party
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Tuğba Aydın
Principal Investigator
Principal Investigators
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TUGBA AYDIN
Role: PRINCIPAL_INVESTIGATOR
İstanbul Physical Therapy Rehabilitation Training & Research Hosptial
Locations
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Tugba Aydin
Istanbul, , Turkey (Türkiye)
Countries
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Central Contacts
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References
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Bair MJ, Krebs EE. Fibromyalgia. Ann Intern Med. 2020 Mar 3;172(5):ITC33-ITC48. doi: 10.7326/AITC202003030.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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IstanbulPMRTRH-Fibromyalgia
Identifier Type: -
Identifier Source: org_study_id
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