FibromyalgiaNCT05295316
Risk Factors of Primary Fibromyalgia
An observational study of Fibromyalgia, run by Studio Osteopatico Busto Arsizio at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Life Stressor Checklist Revised (LSC-R) (Appendix 1)
- How many people
- 94 participants
- Where
- 1 siteItaly
- Study dates
- 12 Apr 2020to 18 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Female patients with or without fibromyalgia
Who may be able to join
- female patients
- Patient from Piedmont
- age between 20 and 65 years old
- inform consent
- for case group primary or secondary fibromyalgia
Who cannot join
- systemic or rheumatic or neoplastic diseases
- for control group the presence of primary or secondary fibromyalgia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Fibromyalgia
- Being tested
- Life Stressor Checklist Revised (LSC-R) (Appendix 1)
- Keywords
- Osteopathy
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Life Stressor Checklist Revised (LSC-R) (Appendix 1)Other
Evaluation of stress factor as risk factor for fibromyalgia development
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Life Stressor Checklist Revised (LSC-R) (Appendix 1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of 29 stressing events
The LSC-R questionnaire was used to evaluate the incidence of each stressor event
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start12 Apr 2020
- Primary completion3 Feb 2021
- Study completion18 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Studio Osteopatico Busto Arsizio
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolina Lavazza, Studio Osteopatico Busto Arsizio
- Investigators
- Carolina Lavazza, MSc, Study chair, Accademia Italiana Medicina Osteopatica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05295316
- Sponsor's protocol ID
- 230176
- Status last verified
- Mar 2022
- First submitted
- 11 Mar 2022
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors Recognition of Primary Fibromyalgia: a Case-control Study
- ClinicalTrials.gov ID
- NCT05295316
- Acronym / sponsor ID
- 230176
- Conditions
- Fibromyalgia
- Keywords
- Osteopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Studio Osteopatico Busto ArsizioUniversity, hospital or other
- Study start
- 12 Apr 2020 (actual)
- Primary completion
- 3 Feb 2021 (actual)
- Study completion
- 18 Oct 2021 (actual)
- First posted
- 25 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibromyalgia | – | Other: Life Stressor Checklist Revised (LSC-R) (Appendix 1)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. |
| Control | – | Other: Life Stressor Checklist Revised (LSC-R) (Appendix 1)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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Female patients with or without fibromyalgia
Key inclusion criteria (5 listed)
- female patients
- Patient from Piedmont
- age between 20 and 65 years old
- inform consent
- for case group primary or secondary fibromyalgia
Key exclusion criteria (2 listed)
- systemic or rheumatic or neoplastic diseases
- for control group the presence of primary or secondary fibromyalgia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Life Stressor Checklist Revised (LSC-R) (Appendix 1)Evaluation of stress factor as risk factor for fibromyalgia development | Other | Control, Fibromyalgia |
Primary outcome
Incidence of 29 stressing events
Time frame: 1 year
The LSC-R questionnaire was used to evaluate the incidence of each stressor event
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolina Lavazza, MSc study chair
Accademia Italiana Medicina Osteopatica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, run by Studio Osteopatico Busto Arsizio at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of 29 stressing events (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2022; AzTrials last refreshed its copy on 7 Nov 2026.