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

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05020600
• Other study ID #: 09.2021.117
• Status: Recruiting
• Start date: August 19, 2021
• Est. completion date: December 1, 2024

Study information

• Verified date: November 2022
• Source: Marmara University
• Contact: Feyza N YUCEL, M.D
• Phone: 05385577059
• Email: dr.fny28[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Central Sensitisation
• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• Duloxetine
First-line fibromyalgia treatment
• Pregabalin
First-line fibromyalgia treatment
• Amitriptyline
First-line fibromyalgia treatment

Locations

Country	Name	City	State
Turkey	Feyza Nur YUCEL	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

Akinci A, Al Shaker M, Chang MH, Cheung CW, Danilov A, Jose Duenas H, Kim YC, Guillen R, Tassanawipas W, Treuer T, Wang Y. Predictive factors and clinical biomarkers for treatment in patients with chronic pain caused by osteoarthritis with a central sensi — View Citation

Bhargava J, Hurley JA. Fibromyalgia. 2022 Oct 10. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK540974/ — View Citation

Mayer TG, Neblett R, Cohen H, Howard KJ, Choi YH, Williams MJ, Perez Y, Gatchel RJ. The development and psychometric validation of the central sensitization inventory. Pain Pract. 2012 Apr;12(4):276-85. doi: 10.1111/j.1533-2500.2011.00493.x. Epub 2011 Sep — View Citation

Neblett R, Hartzell MM, Mayer TG, Cohen H, Gatchel RJ. Establishing Clinically Relevant Severity Levels for the Central Sensitization Inventory. Pain Pract. 2017 Feb;17(2):166-175. doi: 10.1111/papr.12440. Epub 2016 Mar 15. — View Citation

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 Neuro — View Citation

Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Hauser W, Katz RL, Mease PJ, Russell AS, Russell IJ, Walitt B. 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria. Semin Arthritis Rheum. 2016 Dec;46(3):319-329. doi: 10.1016/j.semarthrit.201 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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')	2 year
Primary	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	2 year
Primary	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.	2 year
Primary	Short Form-36	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
Primary	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.	2 year

External Links

•   symptom severity (SS) scale in the diagnostic criteria for fibromyalgia