Risk Factors of Primary Fibromyalgia

Risk Factors Recognition of Primary Fibromyalgia: a Case-control Study

Fibromyalgia (FM) is a condition with a different non-specific symptoms which lead to a difficult diagnosis. Study suggests that osteopathy can help in improving FM symptoms, nevertheless, it can be difficult to identify which patients may benefit. The knowledge of FM risk factor can be useful tool for osteopaths and other clinician to implement a targeted, fast and multidisciplinary treatment protocol for those kind of patient.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Other: Life Stressor Checklist Revised (LSC-R) (Appendix 1)

• Study Type: Observational
• Enrollment (Actual): 94

Contacts and Locations

Study Locations

• Italy
  • Novara, Italy
    • OsteoMedical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Female patients with or without fibromyalgia

Description

Inclusion Criteria:

• female patients
• Patient from Piedmont
• age between 20 and 65 years old
• inform consent
• for case group primary or secondary fibromyalgia

Exclusion Criteria:

• systemic or rheumatic or neoplastic diseases
• for control group the presence of primary or secondary fibromyalgia

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fibromyalgia; FM group was recruited at AMaR (rheumatic patients association of Piedmont) and the diagnosis of primary fibromyalgia was confirmed by the referring rheumatologist of the AMaR association.	Other: Life Stressor Checklist Revised (LSC-R) (Appendix 1); Evaluation of stress factor as risk factor for fibromyalgia development
Control; The control group was recruited in the same geographic area as the FM participant. The general practitioner of each individual patient certified the subject's state of good health.	Other: Life Stressor Checklist Revised (LSC-R) (Appendix 1); Evaluation of stress factor as risk factor for fibromyalgia development

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of 29 stressing events	The LSC-R questionnaire was used to evaluate the incidence of each stressor event	1 year

Collaborators and Investigators

• Sponsor: Studio Osteopatico Busto Arsizio
• Investigators: Study Chair: Carolina Lavazza, MSc, Accademia Italiana Medicina Osteopatica

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2020
• Primary Completion (Actual): February 3, 2021
• Study Completion (Actual): October 18, 2021

Study Registration Dates

• First Submitted: March 11, 2022
• First Submitted That Met QC Criteria: March 24, 2022
• First Posted (Actual): March 25, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2022
• Last Update Submitted That Met QC Criteria: March 24, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Osteopathy
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 230176

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No