The Relationship Between Neuropathic Complaints and Central Sensitization in Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Investigation of the Relationship Between Neuropathic Complaints and Central Sensitization in Patients With Fibromyalgia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05701696
• Other study ID #: 22/640
• Status: Recruiting
• Start date: January 16, 2023
• Est. completion date: November 30, 2023

Study information

• Verified date: January 2023
• Source: Marmara University
• Contact: Feyza Nur Yücel, MD
• Phone: 5385577059
• Email: dr.fny28[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 111
• Est. completion date: November 30, 2023
• Est. primary completion date: August 30, 2023
• Gender: All
• Age group: 18 Years to 65 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

• Polyneuropathy, entrapment neuropathy, and radiculopathy are other diagnosed sources of neuropathic pain.

Related Conditions & MeSH terms

• Central Sensitisation
• Fibromyalgia
• Myofascial Pain Syndromes
• Neuralgia
• Neuropathic Pain

Intervention

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.
• Widespread pain index
Total the number of painful body areas
• Symptom severity scale
The sum of the fatigue, waking unrefreshed and cognitive symptoms and the extent of somatic symptoms

Other:
• Fibromyalgia impact questionnaire
A tool to assess health status in fibromyalgia

Diagnostic Test:
• Hospital Anxiety and Depression Scale
An instrument for detecting depression and anxiety
• Self-Leeds Assessment of Neuropathic Symptoms and Signs
An instrument used to identify pain of neuropathic origin

Locations

Country	Name	City	State
Turkey	University of Health Sciences	Istanbul	Uskudar

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

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. — View Citation

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

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. — 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 Neurosci. 2017 Feb 1;37(5):1090-1101. doi: 10.1523/JNEUROSCI.2619-16.2016. Epub 2016 Dec 16. — View Citation

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. — 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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CSI	Standardized questionnaire to determine the level of central sensitization. Patients with a score of 40 and above are considered to have central sensitization.	1 year
Primary	S-LANSS	Questionnaire used to investigate the neuropathic character of pain. A score =12 points suggests the presence of pain of neuropathic origin	1 year
Secondary	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')	1 year
Secondary	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.	1 year
Secondary	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.	1 year
Secondary	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.	1 year
Secondary	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.	1 year