The Relationship Between Neuropathic Complaints and Central Sensitization in Fibromyalgia

Sponsor
Marmara University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05701696
Collaborator
(none)
111
1
10.4
10.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
111 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Investigation of the Relationship Between Neuropathic Complaints and Central Sensitization in Patients With Fibromyalgia
Actual Study Start Date :
Jan 16, 2023
Anticipated Primary Completion Date :
Aug 30, 2023
Anticipated Study Completion Date :
Nov 30, 2023

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. CSI [1 year]

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

    2. S-LANSS [1 year]

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

    Secondary Outcome Measures

    1. Visual analog scale ( VAS) pain [1 year]

      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')

    2. Fibromyalgia impact scale [1 year]

      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.

    3. Symptom severity scale [1 year]

      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.

    4. Widespread pain index [1 year]

      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.

    5. HADS [1 year]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Health Sciences Istanbul Uskudar Turkey

    Sponsors and Collaborators

    • Marmara University

    Investigators

    • Principal Investigator: Feyza Nur Yücel, MD, Saglik Bilimleri Universitesi

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Marmara University
    ClinicalTrials.gov Identifier:
    NCT05701696
    Other Study ID Numbers:
    • 22/640
    First Posted:
    Jan 27, 2023
    Last Update Posted:
    Jan 27, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 27, 2023