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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05636423
Other study ID # Sex and LBP
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2, 2023
Est. completion date July 10, 2023

Study information

Verified date July 2023
Source University of Bologna
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 502
Est. completion date July 10, 2023
Est. primary completion date June 24, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Survey
Online survey via a questionnaire composed of 28 questions.

Locations

Country Name City State
Italy Policlinico S. Orsola-Malpighi Bologna Emilia-Romagna

Sponsors (1)

Lead Sponsor Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical behaviors of Italian physiotherapists regarding sexual disability in patients with low back pain 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. From date of first completion of the survey until the date of last completion of the survey.
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