NCT05701696

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
111

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 16, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 27, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

February 28, 2023

Status Verified

January 1, 2023

Enrollment Period

8 months

First QC Date

January 18, 2023

Last Update Submit

February 27, 2023

Conditions

Central SensitisationFibromyalgiaNeuropathic Pain

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • Visual analog scale ( VAS) pain

    1 year

  • Fibromyalgia impact scale

    1 year

  • Symptom severity scale

    1 year

  • Widespread pain index

    1 year

  • HADS

    1 year

Study Arms (1)

Patients with fibromyalgia

Patients diagnosed with FM according to ACR 2016 criteria

Diagnostic Test: Central sensitization inventoryDiagnostic Test: Widespread pain indexDiagnostic Test: Symptom severity scaleOther: Fibromyalgia impact questionnaireDiagnostic Test: Hospital Anxiety and Depression ScaleDiagnostic Test: Self-Leeds Assessment of Neuropathic Symptoms and Signs

Interventions

Central sensitization inventoryDIAGNOSTIC_TEST

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

Also known as: CSI
Patients with fibromyalgia
Widespread pain indexDIAGNOSTIC_TEST

Total the number of painful body areas

Also known as: WPI
Patients with fibromyalgia
Symptom severity scaleDIAGNOSTIC_TEST

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

Also known as: SSS
Patients with fibromyalgia
Fibromyalgia impact questionnaireOTHER

A tool to assess health status in fibromyalgia

Also known as: FIQ
Patients with fibromyalgia
Hospital Anxiety and Depression ScaleDIAGNOSTIC_TEST

An instrument for detecting depression and anxiety

Also known as: HADS
Patients with fibromyalgia
Self-Leeds Assessment of Neuropathic Symptoms and SignsDIAGNOSTIC_TEST

An instrument used to identify pain of neuropathic origin

Also known as: S-LANSS
Patients with fibromyalgia

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Fibromyalgia patients

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences

Istanbul, Uskudar, Turkey (Türkiye)

RECRUITING

Related Publications (7)

  • 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.

    PMID: 3272296BACKGROUND

  • 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/

    PMID: 31082018BACKGROUND

  • 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.

    PMID: 27986927BACKGROUND

  • 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.

    PMID: 32940205BACKGROUND

  • 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.

    PMID: 35327414BACKGROUND

  • 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.

    PMID: 11323136BACKGROUND

  • 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.

    PMID: 6880820BACKGROUND

MeSH Terms

Conditions

FibromyalgiaNeuralgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesPeripheral Nervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Feyza Nur Yücel, MD

    Saglik Bilimleri Universitesi

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Feyza Nur Yücel, MD

CONTACT

5385577059dr.fny28@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2023

First Posted

January 27, 2023

Study Start

January 16, 2023

Primary Completion

August 30, 2023

Study Completion

November 30, 2023

Last Updated

February 28, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)