AzTrials
AzTrials

Central SensitisationNCT05701696

The Relationship Between Neuropathic Complaints and Central Sensitization in Fibromyalgia

An observational study of Central Sensitisation and Fibromyalgia, run by Marmara University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Central sensitization inventory, Widespread pain index and Symptom severity scale
How many people
111 participants
Where
1 siteTurkey (Türkiye)
Study dates
16 Jan 2023to 30 Nov 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Adult, Older adult

Study population: Fibromyalgia patients

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Feyza Nur Yücel, MD contact

5385577059

dr.fny28@gmail.com

Turkey (Türkiye)1 site, 1 recruiting

  • University of Health Sciences

    Istanbul, Uskudar

    Feyza Nur Yücel, MD, 5385577059, dr.fny28@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
Central sensitization inventory, Widespread pain index, Symptom severity scale, Fibromyalgia impact questionnaire, Hospital Anxiety and Depression Scale
Medical subject headings
Fibromyalgia, Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Central sensitization inventoryDiagnostic test

    Also called CSI

    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 indexDiagnostic test

    Also called WPI

    Total the number of painful body areas

  • Symptom severity scaleDiagnostic test

    Also called SSS

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

  • Fibromyalgia impact questionnaireOther

    Also called FIQ

    A tool to assess health status in fibromyalgia

  • Hospital Anxiety and Depression ScaleDiagnostic test

    Also called HADS

    An instrument for detecting depression and anxiety

  • Self-Leeds Assessment of Neuropathic Symptoms and SignsDiagnostic test

    Also called S-LANSS

    An instrument used to identify pain of neuropathic origin

Study groups in NCT05701696
Study groupRoleWhat they receive
Patients with fibromyalgiaPatients diagnosed with FM according to ACR 2016 criteria
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CSI

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

    Measured: 1 year

  2. S-LANSS

    Questionnaire used to investigate the neuropathic character of pain. A score ≥12 points suggests the presence of pain of neuropathic origin

    Measured: 1 year

Secondary outcomes (5)

  1. 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')

    Measured: 1 year

  2. 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.

    Measured: 1 year

  3. 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.

    Measured: 1 year

  4. 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.

    Measured: 1 year

  5. 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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2023
  2. Study start16 Jan 2023
  3. Primary completion30 Aug 2023 (estimated)
  4. Study completion30 Nov 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
111 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05701696
Sponsor's protocol ID
22/640
Status last verified
Jan 2023
First submitted
18 Jan 2023
Last updated
28 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 3272296

  • Bhargava J, Goldin J. Fibromyalgia. 2025 Jan 31. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK540974/

    PubMed 31082018

  • 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.

    PubMed 27986927

  • 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.

    PubMed 32940205

  • 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.

    PubMed 35327414

  • 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.

    PubMed 11323136

  • 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.

    PubMed 6880820

Questions about this trial

What is this clinical trial studying?

An observational study of Central Sensitisation and Fibromyalgia, run by Marmara University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Feyza Nur Yücel, MD (5385577059, dr.fny28@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CSI (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05701696, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.

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