The Effect of Sympathetic Dysfunction on Muscle Spindle in Fibromyalgia

NCT05704374 | Unknown

• 1 other identifier: IstanbulPMRTRH-Fibromyalgia
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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).

Conditions

Fibromyalgia

Keywords

fibromyalgia

Outcome Measures

Primary Outcomes (2)

• 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.

  immediately after the intervention

• 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.

  immediately after the intervention

Secondary Outcomes (1)

• Heart rate variability

  immediately after the intervention

Study Arms (2)

Fibromyalgia group

EXPERIMENTAL

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); Drug: Pregabalin 150mg

Healthy control group

OTHER

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)

Interventions

sympathetic stimulation maneuver (mental arithmetic test, cold pressure test) DIAGNOSTIC_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.

Fibromyalgia group; Healthy control group

Pregabalin 150mg DRUG

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.

Also known as: sympathetic block

Fibromyalgia group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Physical Medicine Rehabilitation Training and Research Hospital: lead

Study Sites (1)

Tugba Aydin

Istanbul, 34192, Turkey (Türkiye)

Location

Related Publications (10)

• Bair MJ, Krebs EE. Fibromyalgia. Ann Intern Med. 2020 Mar 3;172(5):ITC33-ITC48. doi: 10.7326/AITC202003030.

  PMID: 32120395 BACKGROUND

• 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.

  PMID: 33454042 BACKGROUND

• 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.

  PMID: 33119628 BACKGROUND

• 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.

  PMID: 25994126 BACKGROUND

• 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.

  PMID: 19101166 BACKGROUND

• 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.

  PMID: 15542572 BACKGROUND

• 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.

  PMID: 23838093 BACKGROUND

• 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.

  PMID: 19411061 BACKGROUND

• 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.

  PMID: 27026828 BACKGROUND

• 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.

  PMID: 20147618 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia

Interventions

Pregabalin; Autonomic Nerve Block

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Nerve Block; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• TUGBA AYDIN

  İstanbul Physical Therapy Rehabilitation Training & Research Hosptial

  PRINCIPAL INVESTIGATOR

Central Study Contacts

TUGBA AYDIN, Assoc Prof

CONTACT

+905324622162; drtugbaaydin@gmail.com

ILHAN KARACAN, Prof

CONTACT

+905327005361; ilhankaracan@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 7, 2023
• First Posted: January 30, 2023
• Study Start: November 2, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 30, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)