Retrospective Study of Psychoattitudinal Patterns in Patients With Fibromyalgia Receiving Antalgic Therapy

Fibromyalgia Clinical Trial

Official title:

A Retrospective Study Concerning the Psycho-attitudinal Classification of Patients Suffering From Fibromyalgia Undergoing a Specialized Analgesic Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04623827
• Other study ID #: FIBRO_PATTERN
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: January 1, 2021

Study information

• Verified date: June 2021
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Fibromyalgia (FM) is a widespread and invalidating disease that requires a multidisciplinary approach. Particularly, the psychiatric component seems to influence the algological management of these patients. Since January 2018, the HADS, SF-36, IMSA, TCI psycho-attitudinal questionnaires have been introduced in the Pain Therapy unit of Policlinico Sant'Orsola-Malpighi in an attempt to improve the care of patients diagnosed with FM.

The aim of the study is to identify, through retrospective evaluation of TCI tests and its subdomains, compiled by patients with FM diagnosis, Pain Avoidance and Pain Persistance personality patterns, indicated in the literature. Anxiety and Depression incidence is also observed through retrospective evaluation of HADS tests.

Patients in the Antalgic Therapy Outpatient Clinic diagnosed with FM, aged ≥18 years, who have completed selfadministered psychoattitudinal tests from January 2018 to January 2019 were considered. The data were collected in aggregate and extrapolated anonymously.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• diagnosis of fibromyalgia

• years = 18

Exclusion Criteria:

• not present

Related Conditions & MeSH terms

• Analgesia
• Chronic Pain
• Fibromyalgia
• Myofascial Pain Syndromes
• Pain Syndrome
• Pain, Chronic

Locations

Country	Name	City	State
Italy	Andrea Fanelli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psycho-attitudinal Pattern	A retrospective evaluation of the Temperament and Character Inventory test scores in the period from January 2018 to January 2019 by patients diagnosed with Fibromyalgia related to the antalgic therapy clinic.	1 year
Secondary	Anxiety and depression	To investigate the presence of moderate to severe anxiety-depressive disorders among patients with anxiety and depression at the antalgic therapy clinic using the HADS tool.	1 year