Risk Factors of Primary Fibromyalgia

NCT05295316 | Completed

• 1 other identifier: 230176
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fibromyalgia

Keywords

Osteopathy

Outcome Measures

Primary Outcomes (1)

• Incidence of 29 stressing events

  The LSC-R questionnaire was used to evaluate the incidence of each stressor event

  1 year

Study Arms (2)

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)

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)

Interventions

Life Stressor Checklist Revised (LSC-R) (Appendix 1) OTHER

Evaluation of stress factor as risk factor for fibromyalgia development

Control; Fibromyalgia

Eligibility Criteria

• Gender Eligibility Details: Female women were used because have higher risk of fibromyalgia development.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Female patients with or without fibromyalgia

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Studio Osteopatico Busto Arsizio: lead

Study Sites (1)

OsteoMedical

Novara, Italy

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Carolina Lavazza, MSc

  Accademia Italiana Medicina Osteopatica

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Osteopath

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: March 25, 2022
• Study Start: April 12, 2020
• Primary Completion: February 3, 2021
• Study Completion: October 18, 2021
• Last Updated: March 25, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)