The Relationship Between Neuropathic Complaints and Central Sensitization in Fibromyalgia

NCT ID: NCT05701696

Last Updated: 2023-02-28

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

111 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-16

Study Completion Date

2023-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Central Sensitisation Fibromyalgia Neuropathic Pain

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients with fibromyalgia

Patients diagnosed with FM according to ACR 2016 criteria

Central sensitization inventory

Intervention Type DIAGNOSTIC_TEST

Standardized questionnaire to determine the level of central sensitization. Patients with a score of 40 and above are considered to have central sensitization.

Widespread pain index

Intervention Type DIAGNOSTIC_TEST

Total the number of painful body areas

Symptom severity scale

Intervention Type DIAGNOSTIC_TEST

The sum of the fatigue, waking unrefreshed and cognitive symptoms and the extent of somatic symptoms

Fibromyalgia impact questionnaire

Intervention Type OTHER

A tool to assess health status in fibromyalgia

Hospital Anxiety and Depression Scale

Intervention Type DIAGNOSTIC_TEST

An instrument for detecting depression and anxiety

Self-Leeds Assessment of Neuropathic Symptoms and Signs

Intervention Type DIAGNOSTIC_TEST

An instrument used to identify pain of neuropathic origin

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Widespread pain index

Total the number of painful body areas

Intervention Type DIAGNOSTIC_TEST

Symptom severity scale

The sum of the fatigue, waking unrefreshed and cognitive symptoms and the extent of somatic symptoms

Intervention Type DIAGNOSTIC_TEST

Fibromyalgia impact questionnaire

A tool to assess health status in fibromyalgia

Intervention Type OTHER

Hospital Anxiety and Depression Scale

An instrument for detecting depression and anxiety

Intervention Type DIAGNOSTIC_TEST

Self-Leeds Assessment of Neuropathic Symptoms and Signs

An instrument used to identify pain of neuropathic origin

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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CSI WPI SSS FIQ HADS S-LANSS

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Feyza Nur Yücel, MD

Role: PRINCIPAL_INVESTIGATOR

Saglik Bilimleri Universitesi

Locations

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University of Health Sciences

Istanbul, Uskudar, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Feyza Nur Yücel, MD

Role: CONTACT

5385577059

Facility Contacts

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Feyza Nur Yücel, MD

Role: primary

5385577059

References

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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.

Reference Type BACKGROUND
PMID: 3272296 (View on PubMed)

Bhargava J, Goldin J. Fibromyalgia. 2025 Jan 31. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK540974/

Reference Type BACKGROUND
PMID: 31082018 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27986927 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32940205 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35327414 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11323136 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6880820 (View on PubMed)

Other Identifiers

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22/640

Identifier Type: -

Identifier Source: org_study_id

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