Low Back PainNCT05636423
Sexual Disability in Low Back Pain and Physiotherapy
An observational study of Low Back Pain and Sex Disorder, run by University of Bologna at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Sex Disorder
- What is being tested?
- Survey
- How many people
- 502 participants
- Where
- 1 siteItaly
- Study dates
- 2 Feb 2023to 10 Jul 2023
- 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
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Physiotherapists registered with AIFI who deliver physiotherapy treatments on subjects with low back pain
Who may be able to join
- 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
Who cannot join
- Inability to understand written Italian
- Being a retired physiotherapist
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read more
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.
Read the 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.
- Conditions
- Low Back Pain, Sex Disorder
- Being tested
- Survey
- Keywords
- sexual disability, physical therapy, low back pain
- Medical subject headings
- Low Back Pain, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Online survey via a questionnaire composed of 28 questions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From date of first completion of the survey until the date of last completion of the survey.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start2 Feb 2023
- Primary completion24 Jun 2023
- Study completion10 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 502 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Pillastrini, University of Bologna
- Investigators
- Paolo Pillastrini, PT, MSc, Principal investigator, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636423
- Sponsor's protocol ID
- Sex and LBP
- Status last verified
- Jul 2023
- First submitted
- 16 Nov 2022
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32931339Ferrari 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.
PubMed 31037010
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Disability Related to Low Back Pain. Online Survey Among Italian Physiotherapists.
- ClinicalTrials.gov ID
- NCT05636423
- Acronym / sponsor ID
- Sex and LBP
- Conditions
- Low Back Pain, Sex Disorder
- Keywords
- sexual disability, physical therapy, low back pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 502 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 24 Jun 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 5 Dec 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Italian physiotherapists | – | Other: SurveyThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Physiotherapists registered with AIFI who deliver physiotherapy treatments on subjects with low back pain
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Inability to understand written Italian
- Being a retired physiotherapist
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 |
|---|---|---|
| SurveyOnline survey via a questionnaire composed of 28 questions. | Other | Italian physiotherapists |
Primary outcome
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.
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.
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 12 Jul 2023.
- Background: PubMed 32931339Ferrari 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.
- Background: PubMed 31037010Ferrari 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.
- 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.
Paolo Pillastrini, PT, MSc principal investigator
University of Bologna
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 Low Back Pain and Sex Disorder, run by University of Bologna 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 4 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 12 Jul 2023. 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?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05636423, which also lists 2 linked publications.
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 12 Jul 2023.