The Effect of Central Sensitization on Treatment Response in Patients With Fibromyalgia

August 12, 2023 updated by: Marmara University

Investigation of the Effect of Initial Central Sensitization Severity on Treatment Response in Patients With Fibromyalgia

Central sensitization (CS) is as increased response to normal or sub-threshold stimuli of central nervous system and its close relationship with fibromyalgia has been demonstrated in several studies. However, the effect of initial CS severity on treatment response in these patients is not fully known. In this study, it was aimed to investigate the severity of CS and its effect on treatment response in patients with fibromyalgia.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Fibromyalgia 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 central sensitization-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 central sensitization in patients with fibromyalgia, strengthen the relationship between fibromyalgia and central sensitization. The central sensitization inventory (CSI) was developed in 2012 to be used in the recognition of central sensitivity syndromes in patients with fibromyalgia. A score of 40 and above is accepted in favor of central sensitization in the scale, which consists of two parts, in which central sensitization-related symptoms and diagnoses are questioned; scores of 30-39 are classified as mild, 40-49 moderate, 50-59 severe, and 60-100 very severe. Parallel to the increase in the CSI score, an increase is observed in patients' pain severity, disability, depressive symptoms and sleep disorders.In addition, it has been reported in the literature that factors such as pre-treatment pain severity and depression affect the treatment response.Considering all these factors, it is possible that there is a relationship between the severity of central sensitization and treatment response in patients with fibromyalgia.Based on this, in this study, it was aimed to investigate the effect of central sensitization severity, which was evaluated with CSI before treatment, on the treatment process.

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • İstanbul, Turkey, 34899
        • Recruiting
        • Feyza Nur YUCEL
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with fibromyalgia
Patients diagnosed with fibromyalgia according to American College of Rheumatology 2016 criteria
Drug: Duloxetine
First-line fibromyalgia treatment
Other Names:
  • Dyloxia
Drug: Pregabalin
First-line fibromyalgia treatment
Other Names:
  • Lyrica
Drug: Amitriptyline
First-line fibromyalgia treatment
Other Names:
  • Laroxyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analog scale ( VAS) pain
Time Frame: 2 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 year
Symptom severity scale
Time Frame: 2 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
2 year
Fibromyalgia impact scale
Time Frame: 2 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.
2 year
Short Form-36
Time Frame: 2 year
Standardized questionnaire to investigate the quality of life in patients. The score of the scale is between 0-100. The higher scores are associated with greater deterioration in quality of life.
2 year
Central sensitization inventory
Time Frame: 2 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 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Investigators

  • Study Director: Canan SANAL TOPRAK, assoc. prof., Marmara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 19, 2021

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

August 18, 2021

First Submitted That Met QC Criteria

August 19, 2021

First Posted (Actual)

August 25, 2021

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 12, 2023

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09.2021.117

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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