The Relationship Between Neuropathic Complaints and Central Sensitization in Fibromyalgia

Investigation of the Relationship Between Neuropathic Complaints and Central Sensitization in Patients With Fibromyalgia

Fibromyalgia (FM) is the prototype of a group of diseases known as central sensitivity syndromes, whose relationship with pain sensitization is well defined. Central sensitization (CS) is also one of the mechanisms involved in the pathophysiology of neuropathic pain. Neuropathic pain, which is a common complaint in FM patients, is likely to be one of the clinical manifestations of central sensitization. Therefore, in this study, it was aimed to investigate the relationship between CS and neuropathic pain.

Study Overview

• Status: Recruiting
• Conditions: Fibromyalgia; Neuropathic Pain; Central Sensitisation
• Intervention / Treatment: Diagnostic test: Central sensitization inventory; Diagnostic test: Widespread pain index; Diagnostic test: Symptom severity scale; Other: Fibromyalgia impact questionnaire; Diagnostic test: Hospital Anxiety and Depression Scale; Diagnostic test: Self-Leeds Assessment of Neuropathic Symptoms and Signs

Detailed Description

The term central sensitization (CS) was first used by Wolf in 1988 and explained as an increase in pain sensitivity with the amplification of neuron-derived signals in the central nervous system. Fibromyalgia (FM) is a disease characterized by chronic widespread pain and its etiology and pathophysiology are still unknown. It is considered to be the main member of the CS related disease group known as central sensitivity syndromes with impaired pain regulation. In various studies, hyperalgesia and allodynia, which are accepted as objective findings of CS in pain sensitization. In addition to widespread body pain, neuropathic pain is one of the common symptoms in FM, and various studies have shown a significant increase in neuropathic pain in FM patients compared to healthy controls. It is known that CS is one of the basic mechanisms in the etiopathogenesis of neuropathic pain as well as its role in FM. In a study of FM patients, painDETECT and S-LANSS scores were found to be correlated with CSI scores, and the authors emphasized the relationship between pain sensitization and neuropathic complaints in these patients. CS seems likely to be one of the neuropathic pain mechanisms in FM patients, and the available data seem insufficient to draw a definitive conclusion. From this point of view, in this study, it was aimed to investigate the relationship between the presence and severity of CS and the neuropathic pain component of the disease in patients with FM.

• Study Type: Observational
• Enrollment (Anticipated): 111

Contacts and Locations

• Study Contact: Name: Feyza Nur Yücel, MD; Phone Number: 5385577059; Email: dr.fny28@gmail.com

Study Locations

• Turkey
  • Uskudar
    • Istanbul, Uskudar, Turkey
      • Recruiting
      • University of Health Sciences
      • Contact: Feyza Nur Yücel, MD; Phone Number: 5385577059; Email: dr.fny28@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Fibromyalgia patients

Description

Inclusion Criteria:

• Diagnosing fibromyalgia according to ACR 2016 criteria
• Between the ages of 18-65
• Agree to participate in the study

Exclusion Criteria:

• History of concomitant systemic inflammatory disease, active infection and malignancy
• Refusing to participate in the study
• Polyneuropathy, entrapment neuropathy, and radiculopathy are other diagnosed sources of neuropathic pain.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients with fibromyalgia; Patients diagnosed with FM according to ACR 2016 criteria

Diagnostic test: Central sensitization inventory; Standardized questionnaire to determine the level of central sensitization. Patients with a score of 40 and above are considered to have central sensitization.; Other Names: CSI; Diagnostic test: Widespread pain index; Total the number of painful body areas; Other Names: WPI; Diagnostic test: Symptom severity scale; The sum of the fatigue, waking unrefreshed and cognitive symptoms and the extent of somatic symptoms; Other Names: SSS; Other: Fibromyalgia impact questionnaire; A tool to assess health status in fibromyalgia; Other Names: FIQ; Diagnostic test: Hospital Anxiety and Depression Scale; An instrument for detecting depression and anxiety; Other Names: HADS; Diagnostic test: Self-Leeds Assessment of Neuropathic Symptoms and Signs; An instrument used to identify pain of neuropathic origin; Other Names: S-LANSS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CSI	Standardized questionnaire to determine the level of central sensitization. Patients with a score of 40 and above are considered to have central sensitization.	1 year
S-LANSS	Questionnaire used to investigate the neuropathic character of pain. A score ≥12 points suggests the presence of pain of neuropathic origin	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analog scale ( VAS) pain	Pain rating scale. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')	1 year
Fibromyalgia impact scale	The questionnaire was developed to determine the degree of being affected by the disease in patients with a diagnosis of fibromyalgia.The scale consists of 10 parts in total, and the first part is a Likert scale containing 11 questions. High scores indicate that the patient is overly affected.	1 year
Symptom severity scale	The SS scale quantifies symptom severity on a 0-12 scale by scoring problems with fatigue, cognitive dysfunction and unrefreshed sleep over the past week. SSI ≥ 5 favors fibromyalgia.	1 year
Widespread pain index	In this scale, the areas with pain in the last 7 days are marked from a total of 5 regions, including the right and left upper region, the right and left lower region, and the axial region. The total score is between 0-19, and YAS ≥ 7 points is significant for the diagnosis of fibromyalgia.	1 year
HADS	The scale consists of 14 questions, 7 of which are anxiety and 7 are depression.More than 10 points for anxiety and 7 points for depression are considered significant.	1 year

Collaborators and Investigators

• Sponsor: Marmara University
• Investigators: Principal Investigator: Feyza Nur Yücel, MD, Saglik Bilimleri Universitesi

Publications and helpful links

General Publications

• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
• Bennett M. The LANSS Pain Scale: the Leeds assessment of neuropathic symptoms and signs. Pain. 2001 May;92(1-2):147-57. doi: 10.1016/s0304-3959(00)00482-6.
• Woolf CJ, Thompson SW, King AE. Prolonged primary afferent induced alterations in dorsal horn neurones, an intracellular analysis in vivo and in vitro. J Physiol (Paris). 1988-1989;83(3):255-66.
• Bhargava J, Hurley JA. Fibromyalgia. 2022 Oct 10. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK540974/
• Pomares FB, Funck T, Feier NA, Roy S, Daigle-Martel A, Ceko M, Narayanan S, Araujo D, Thiel A, Stikov N, Fitzcharles MA, Schweinhardt P. Histological Underpinnings of Grey Matter Changes in Fibromyalgia Investigated Using Multimodal Brain Imaging. J Neurosci. 2017 Feb 1;37(5):1090-1101. doi: 10.1523/JNEUROSCI.2619-16.2016. Epub 2016 Dec 16.
• Martinez-Lavin M. Fibromyalgia in women: somatisation or stress-evoked, sex-dimorphic neuropathic pain? Clin Exp Rheumatol. 2021 Mar-Apr;39(2):422-425. doi: 10.55563/clinexprheumatol/0c7d6v. Epub 2020 Sep 16.
• Ubeda-D'Ocasar E, Valera-Calero JA, Gallego-Sendarrubias GM, Fernandez-de-Las-Penas C, Arias-Buria JL, Morales-Cabezas M, Arendt-Nielsen L, Cigaran-Mendez M. Association of Neuropathic Pain Symptoms with Sensitization Related Symptomatology in Women with Fibromyalgia. Biomedicines. 2022 Mar 6;10(3):612. doi: 10.3390/biomedicines10030612.

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2023
• Primary Completion (Anticipated): August 30, 2023
• Study Completion (Anticipated): November 30, 2023

Study Registration Dates

• First Submitted: January 18, 2023
• First Submitted That Met QC Criteria: January 18, 2023
• First Posted (Actual): January 27, 2023

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 22/640

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