- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05636423
Sexual Disability in Low Back Pain and Physiotherapy
Sexual Disability Related to Low Back Pain. Online Survey Among Italian Physiotherapists.
A treatment centered on the person uses an approach capable of considering all the components of disability, from a physical, psychological and social point of views. Some studies have shown that sexual function is disturbed in subjects with low back pain (LBP) and sexual disability can contribute to a deterioration in quality of life. It has also been shown that, in sexually active patients complaining of LBP, sexuality is a significant mediator of the relationship between pain intensity and depressive symptoms.
The Oswestry Disability Index (ODI) includes a specific item to investigate sexual function (item #8). A previous study of ours confirmed the relationship between sexual disability detected by the ODI and the presence of depression, avoidance of activities and rumination (Ferrari et al. 2019 - Digital Object Identifier: 10.1589/jpts.31.360).
The discussion on sexual disability among patients and healthcare professionals is very limited, although patients require more involvement from clinicians, especially physiotherapists, as evidenced by our previous qualitative study (Ferrari et al. 2020 - Digital Object Identifier: 10.1080/09638288.2020 .1817161).
Although studies on this topic have highlighted the importance of this disability in the life of subjects complaining of LBP, little has been investigated on clinical behaviors of the physiotherapists in this area.
Study Overview
Detailed Description
The goal of this observational study is to learn about the clinical behaviors of Italian physiotherapists in the management of LBP-related sexual disability. The main questions it aims to answer are:
- the knowledge of this topic;
- the ways in which sexual disability is detected in patients complaining of LBP (Oswestry Disability Index, specific open or closed questions, patient' reporting, etc.);
- the difficulties and obstacles in the management of sexual disability;
- the suggestions provided to the patient;
- the therapeutic strategies (procedures for pain modulation, exercises addressed to lumbar mobility, strength, endurance, etc.);
- the possible involvement of the patient' partner;
- the outcome measures.
The hypothesis of this survey is to highlight the degree of attention and competence of Italian physiotherapists with respect to this topic, the critical issues and therapeutic strategies for the management of LBP-related sexual disability.
Participants will answer to a online questionnaire.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Emilia-Romagna
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Bologna, Emilia-Romagna, Italy, 40138
- Policlinico S. Orsola-Malpighi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Being a physiotherapist registered with AIFI
- Carrying out physiotherapy treatments on subjects with low back pain
- Agreement to voluntarily sign informed consent to participate in the study
- Agreement to voluntarily sign consent to data processing
Exclusion Criteria:
- Inability to understand written Italian
- Being a retired physiotherapist
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Italian physiotherapists
The survey will take place through the administration of a questionnaire accessible via the website of the Italian Physiotherapy Association (AIFI), the Scientific Association of reference for the physiotherapists, registered since 2020 in the list of Scientific Societies recognized by the Italian Health Ministry.
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Online survey via a questionnaire composed of 28 questions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical behaviors of Italian physiotherapists regarding sexual disability in patients with low back pain
Time Frame: From date of first completion of the survey until the date of last completion of the survey.
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Level of attention and competence of Italian physiotherapists with respect to sexual disability related to low back pain, critical issues, opportunities and therapeutic strategies adopted in the management of sexual disability related to LBP.
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From date of first completion of the survey until the date of last completion of the survey.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Paolo Pillastrini, PT, MSc, University of Bologna
Publications and helpful links
General Publications
- Ferrari S, Vanti C, Giagio S, Anesi M, Youssef S, Bortolami A, Cedraschi C, Pillastrini P. Low back pain and sexual disability from the patient's perspective: a qualitative study. Disabil Rehabil. 2022 May;44(10):2011-2019. doi: 10.1080/09638288.2020.1817161. Epub 2020 Sep 15.
- Ferrari S, Vanti C, Frigau L, Guccione AA, Mola F, Ruggeri M, Pillastrini P, Monticone M. Sexual disability in patients with chronic non-specific low back pain-a multicenter retrospective analysis. J Phys Ther Sci. 2019 Apr;31(4):360-365. doi: 10.1589/jpts.31.360. Epub 2019 Apr 1.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Sex and LBP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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