NCT05636423

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
502

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 5, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

February 2, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2023

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2023

Completed
Last Updated

July 12, 2023

Status Verified

July 1, 2023

Enrollment Period

5 months

First QC Date

November 16, 2022

Last Update Submit

July 11, 2023

Conditions

Keywords

sexual disabilityphysical therapylow back pain

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

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.

Other: Survey

Interventions

SurveyOTHER

Online survey via a questionnaire composed of 28 questions.

Italian physiotherapists

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Physiotherapists registered with AIFI who deliver physiotherapy treatments on subjects with low back pain

You may qualify if:

  • 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

You may not qualify if:

  • Inability to understand written Italian
  • Being a retired physiotherapist

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico S. Orsola-Malpighi

Bologna, Emilia-Romagna, 40138, Italy

Location

Related Publications (2)

  • 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.

    PMID: 32931339BACKGROUND
  • 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.

    PMID: 31037010BACKGROUND

MeSH Terms

Conditions

Low Back PainSexual Dysfunction, Physiological

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsGenital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Paolo Pillastrini, PT, MSc

    University of Bologna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

November 16, 2022

First Posted

December 5, 2022

Study Start

February 2, 2023

Primary Completion

June 24, 2023

Study Completion

July 10, 2023

Last Updated

July 12, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations