Clinical trial NCT05636423: Sexual Disability in Low Back Pain and Physiotherapy
Official title: Sexual Disability Related to Low Back Pain. Online Survey Among Italian Physiotherapists.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Sex Disorder
Keywords: sexual disability
physical therapy
low back pain
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2022-12-05
Enrollment: 502
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Physiotherapists registered with AIFI who deliver physiotherapy treatments on subjects with low back pain

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical behaviors of Italian physiotherapists regarding sexual disability in patients with low back pain
timeFrame: From date of first completion of the survey until the date of last completion of the survey.
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Policlinico S. Orsola-Malpighi
state: Emilia-Romagna
Study officials:
affiliation: University of Bologna
name: Paolo Pillastrini, PT, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.