Retrospective Study of Psychoattitudinal Patterns in Pati... | NCT04623827

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

NCT04623827

Sponsor

University of Bologna

Status

Completed

Last Update Posted

Jun 23, 2021Actual

Enrollment

32Actual

Phase

Not provided

Conditions

Analgesia
Fibromyalgia
Pain, Chronic
Pain Syndrome

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Jan 1, 2018Actual

Completion Date

Jan 1, 2021Actual

First Submitted Date

Sep 19, 2020

First Submission Date that Met QC Criteria

Nov 9, 2020

First Posted Date

Nov 10, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2021

Last Update Posted Date

Jun 23, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diagnosis of fibromyalgia
years ≥ 18

Exclusion Criteria:

not present

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with a diagnosis of fibromyalgia who come to the pain therapy service over the age of 18 between January 2018 and January 2019..

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Andrea Fanelli		Bologna		40138	Italy

Condition Browse Module

MeSH Terms

ID	Term
D000377	Agnosia
D005356	Fibromyalgia
D059350	Chronic Pain
D013001	Somatoform Disorders

Ancestor Terms

ID	Term
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided