SpondylolisthesisNCT06799975
Effects of a Single Session of Physiotherapy on Patients Operated for Lumbar Spondylolisthesis
A study testing Education in people with Spondylolisthesis, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
The goal of this clinical trial is to investigate whether a meeting with physiotherapist before hospital discharge can improve the post-operative outcomes in patients who have undergone lumbar fusion surgery for spondylolisthesis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondylolisthesis
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Patients who have undergone lumbar fusion surgery due to monosegmental lumbar spondylolisthesis.
Who cannot join
- Patients who have undergone previous lumbar surgeries
- Patients operated on for other lumbar pathologies
- Patients with pre-existing neurological deficits not related to the condition being treated
- Patients with systemic conditions (inflammatory, infectious, neoplastic, etc.) or neuromuscular disorders
- Patients with cognitive deficits or psychiatric disorders
- Patients who do not speak Italian fluently
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ali Baram contact
Italy1 site
Humanitas Research Hospital
Rozzano, Milan, 20089
Roberto Gatti, 0282245610, roberto.gatti@hunimed.eu
About this study
Official title: Effects of a Single Session of Physiotherapy on Pain, Disability and Psychological Risk Factors in Patients Operated for Lumbar Spondylolisthesis: a Randomized Controlled Study
The goal of this clinical trial is to investigate whether a meeting with physiotherapist before hospital discharge can improve the post-operative outcomes in patients who have undergone lumbar fusion surgery for spondylolisthesis.
The main question it aims to answer is:
Read more
- The primary endpoint investigated is the degree of disability measured using the ODI-I one month after the surgical intervention.
- The secondary endpoints are the level of pain measured using the NRS scale at 1 and 3 months post-surgery; disability at 3 months measured using the ODI-I questionnaire; physical function assessed using the UWT at 1 and 3 months post-surgery; psychological factors such as self-efficacy and fear of movement measured using the TSK and PSEQ-I at 1 and 3 months after lumbar fusion surgery; health status and quality of life measured at 3 months with the HADS-I and SF-36-I questionnaires; and the patient's satisfaction regarding their hospital stay, assessed using a PREMs questionnaire administered at the time of discharge.
The "usual care" group will instead be discharged by the spinal surgeon following the standard procedures.
The physiotherapist will provide the patient with advice regarding their return home and will suggest simple exercise to be performed at home until the next visit, one month after surgery. Additionally, the patient will have the opportunity to communicate, either by email or phone, with the physiotherapist until the follow-up visit with the spinal surgeon.
- Conditions
- Spondylolisthesis
- Being tested
- Education, Usual Care
- Keywords
- lumbar spondylolisthesis, physiotherapy, disability, psychological factors, randomized controlled trial
- Medical subject headings
- Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
Patients in the "education" group will have a meeting with a physiotherapist at the end of the T1 evaluation, which will take place in a suitable room that ensures privacy is maintained. During this meeting, the physiotherapist will provide the patient with advice regarding their return home and will suggest simple exercises to activate/maintain the abdominal and lower back muscles, to be performed at home until the next visit, one month after the surgery. These exercises are part of standard clinical practice and should be routinely performed by patients who undergo lumbar spinal fusion in the period following the surgery. Additionally, the patient will have the opportunity to communicate, via email or phone, with the physiotherapist until the follow-up appointment with the spine surgeon (scheduled for one month later).
Usual CareOther
The usual discharge procedures consist of a brief interview with the neurosurgeon during which instructions are provided on how to manage the first month after the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Education | Experimental | The intervention consists of a single physiotherapy session before discharge. Receives: Other: Education |
| Usual care | Active comparator | Usual discharge procedures Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Oswestry Disability Index
Validated questionnaire to assess the patient's disability
Measured: From enrollment to the 1 month follow-up
Secondary outcomes (18)
Changes in Numeric Rating Scale
Scale assessing the perceived pain
Measured: From enrollment to the 1 month follow-up
Changes in Numeric Rating Scale
Scale assessing the perceived pain
Measured: From enrollment to the 3 months follow-up
Changes in Numeric Rating Scale
Scale assessing the perceived pain
Measured: From 1 month to the 3 months follow-up
Changes in Oswestry Disability Index
Validated questionnaire to assess the patient's disability
Measured: From enrollment to the 3 months follow-up
Changes in Oswestry Disability Index
Validated questionnaire to assess the patient's disability
Measured: From 1 month follow-up to the 3 months follow-up
Changes in Hospital Anxiety and Depression Scale
Validated questionnaire to assess the anxiety and depression
Measured: From enrollment to the 1 month follow-up
Changes in Hospital Anxiety and Depression Scale
Validated questionnaire to assess the anxiety and depression
Measured: From enrollment to the 3 months follow-up
Changes in Hospital Anxiety and Depression Scale
Validated questionnaire to assess the anxiety and depression
Measured: From 1 month follow-up to the 3 months follow-up
Changes in Pain Self-Efficacy Questionnaire
Validated questionnaire to assess the self-efficacy
Measured: From enrollment to the 1 month follow-up
Changes in Pain Self-Efficacy Questionnaire
Validated questionnaire to assess the self-efficacy
Measured: From enrollment to the 3 months follow-up
Changes in Pain Self-Efficay Questionnaire
Validated questionnaire to assess the self-efficacy
Measured: From 1 month follow-up to the 3 months follow-up
Changes in Short Form Health Survey 36
Validated questionnaire to assess the quality of life
Measured: From enrollment to the 3 months follow-up
Changes in Tampa Scale of Kinesiophobia
Validated questionnaire to assess the kinesiophobia
Measured: From enrollment to the 1 month follow-up
Changes in Tampa Scale of Kinesiophobia
Validated questionnaire to assess the kinesiophobia
Measured: From enrollment to the 3 months follow-up
Changes in Tampa Scale of Kinesiophobia
Validated questionnaire to assess the kinesiophobia
Measured: From 1 month follow-up to the 3 months follow-up
Changes in Up and Walking Test
Physical test to assess the patient's functional status. The test consists of standing up from a chair without using the upper limbs, walking 5 meters, turning around, walking back, and sitting down again without using the upper limbs.
Measured: From enrollment to the 1 month follow-up
Changes in Up and Walking Test
Physical test to assess the patient's functional status. The test consists of standing up from a chair without using the upper limbs, walking 5 meters, turning around, walking back, and sitting down again without using the upper limbs.
Measured: From enrollment to the 3 months follow-up
Changes in Up and Walking Test
Physical test to assess the patient's functional status. The test consists of standing up from a chair without using the upper limbs, walking 5 meters, turning around, walking back, and sitting down again without using the upper limbs.
Measured: From 1 month follow-up to the 3 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start1 Mar 2025 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondylolisthesisStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06799975
- Sponsor's protocol ID
- CLF23/00
- Status last verified
- Jan 2025
- First submitted
- 24 Jan 2025
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Single Session of Physiotherapy on Pain, Disability and Psychological Risk Factors in Patients Operated for Lumbar Spondylolisthesis: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06799975
- Acronym / sponsor ID
- CLF23/00
- Conditions
- Spondylolisthesis
- Keywords
- lumbar spondylolisthesis, physiotherapy, disability, psychological factors, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 29 Jan 2025 (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.
The goal of this clinical trial is to investigate whether a meeting with physiotherapist before hospital discharge can improve the post-operative outcomes in patients who have undergone lumbar fusion surgery for spondylolisthesis.
The main question it aims to answer is:
- The primary endpoint investigated is the degree of disability measured using the ODI-I one month after the surgical intervention.
- The secondary endpoints are the level of pain measured using the NRS scale at 1 and 3 months post-surgery; disability at 3 months measured using the ODI-I questionnaire; physical function assessed using the UWT at 1 and 3 months post-surgery; psychological factors such as self-efficacy and fear of movement measured using the TSK and PSEQ-I at 1 and 3 months after lumbar fusion surgery; health status and quality of life measured at 3 months with the HADS-I and SF-36-I questionnaires; and the patient's satisfaction regarding their hospital stay, assessed using a PREMs questionnaire administered at the time of discharge.
The "usual care" group will instead be discharged by the spinal surgeon following the standard procedures.
The physiotherapist will provide the patient with advice regarding their return home and will suggest simple exercise to be performed at home until the next visit, one month after surgery. Additionally, the patient will have the opportunity to communicate, either by email or phone, with the physiotherapist until the follow-up visit with the spinal surgeon.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education | Experimental | Other: EducationThe intervention consists of a single physiotherapy session before discharge. |
| Usual care | Active comparator | Other: Usual CareUsual discharge procedures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18 years
- Patients who have undergone lumbar fusion surgery due to monosegmental lumbar spondylolisthesis.
Key exclusion criteria (6 listed)
- Patients who have undergone previous lumbar surgeries
- Patients operated on for other lumbar pathologies
- Patients with pre-existing neurological deficits not related to the condition being treated
- Patients with systemic conditions (inflammatory, infectious, neoplastic, etc.) or neuromuscular disorders
- Patients with cognitive deficits or psychiatric disorders
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 |
|---|---|---|
| EducationPatients in the "education" group will have a meeting with a physiotherapist at the end of the T1 evaluation, which will take place in a suitable room that ensures privacy is maintained. During this meeting, the physiotherapist will provide the patient with advice regarding their return home and will suggest simple exercises to activate/maintain the abdominal and lower back muscles, to be performed at home until the next visit, one month after the surgery. These exercises are part of standard clinical practice and should be routinely performed by patients who undergo lumbar spinal fusion in the period following the surgery. Additionally, the patient will have the opportunity to communicate, via email or phone, with the physiotherapist until the follow-up appointment with the spine surgeon (scheduled for one month later). | Other | Education |
| Usual CareThe usual discharge procedures consist of a brief interview with the neurosurgeon during which instructions are provided on how to manage the first month after the surgery. | Other | Usual care |
Primary outcome
Changes in Oswestry Disability Index
Time frame: From enrollment to the 1 month follow-up
Validated questionnaire to assess the patient's disability
18 secondary outcomes
Changes in Numeric Rating Scale
Time frame: From enrollment to the 1 month follow-up
Changes in Numeric Rating Scale
Time frame: From enrollment to the 3 months follow-up
Changes in Numeric Rating Scale
Time frame: From 1 month to the 3 months follow-up
Changes in Oswestry Disability Index
Time frame: From enrollment to the 3 months follow-up
Changes in Oswestry Disability Index
Time frame: From 1 month follow-up to the 3 months follow-up
Changes in Hospital Anxiety and Depression Scale
Time frame: From enrollment to the 1 month follow-up
Changes in Hospital Anxiety and Depression Scale
Time frame: From enrollment to the 3 months follow-up
Changes in Hospital Anxiety and Depression Scale
Time frame: From 1 month follow-up to the 3 months follow-up
Changes in Pain Self-Efficacy Questionnaire
Time frame: From enrollment to the 1 month follow-up
Changes in Pain Self-Efficacy Questionnaire
Time frame: From enrollment to the 3 months follow-up
Changes in Pain Self-Efficay Questionnaire
Time frame: From 1 month follow-up to the 3 months follow-up
Changes in Short Form Health Survey 36
Time frame: From enrollment to the 3 months follow-up
Changes in Tampa Scale of Kinesiophobia
Time frame: From enrollment to the 1 month follow-up
Changes in Tampa Scale of Kinesiophobia
Time frame: From enrollment to the 3 months follow-up
Changes in Tampa Scale of Kinesiophobia
Time frame: From 1 month follow-up to the 3 months follow-up
Changes in Up and Walking Test
Time frame: From enrollment to the 1 month follow-up
Changes in Up and Walking Test
Time frame: From enrollment to the 3 months follow-up
Changes in Up and Walking Test
Time frame: From 1 month follow-up to the 3 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
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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.
Ali Baram contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Spondylolisthesis, run by Istituto Clinico Humanitas 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 2 inclusion and 6 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: opening soon, as of the sponsor's last update on 29 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roberto Gatti (0282245610, roberto.gatti@hunimed.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Oswestry Disability Index (time frame: From enrollment to the 1 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2025.