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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05020600
Recruitment Status : Recruiting
First Posted : August 25, 2021
Last Update Posted : August 25, 2021
Information provided by (Responsible Party):
Marmara University

Brief Summary:
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.

Condition or disease Intervention/treatment
Central Sensitisation Fibromyalgia Drug: Duloxetine

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.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigation of the Effect of Initial Central Sensitization Severity on Treatment Response in Patients With Fibromyalgia
Actual Study Start Date : August 19, 2021
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

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

Primary Outcome Measures :
  1. 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. 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

  3. 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.

  4. 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.

  5. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Fibromyalgia patients

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05020600

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Contact: Feyza N YUCEL, M.D 05385577059

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Feyza Nur YUCEL Recruiting
İstanbul, Turkey, 34899
Contact: Feyza Nur YUCEL, M.D    05385577059   
Sponsors and Collaborators
Marmara University
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Study Director: Canan SANAL TOPRAK, assoc. prof. Marmara University
Additional Information:
Publications of Results:

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Responsible Party: Marmara University Identifier: NCT05020600    
Other Study ID Numbers: 09.2021.117
First Posted: August 25, 2021    Key Record Dates
Last Update Posted: August 25, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents