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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 "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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Education | Experimental | The intervention consists of a single physiotherapy session before discharge. |
|
| Usual care | Active Comparator | Usual discharge procedures |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Oswestry Disability Index | Validated questionnaire to assess the patient's disability | From enrollment to the 1 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Numeric Rating Scale | Scale assessing the perceived pain | From enrollment to the 1 month follow-up |
| Changes in Numeric Rating Scale | Scale assessing the perceived pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roberto Gatti | Contact | 0282245610 | roberto.gatti@hunimed.eu | |
| Ali Baram | Contact | ali.baram@humanitas.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humanitas Research Hospital | Rozzano | Milan | 20089 | Italy |
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| ID | Term |
|---|---|
| D013168 | Spondylolisthesis |
| ID | Term |
|---|---|
| D013169 | Spondylolysis |
| D055009 | Spondylosis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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The assessor was unaware of the participant's intervention group, as was the investigator.
|
| Usual Care | Other | 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. |
|
| From enrollment to the 3 months follow-up |
| Changes in Numeric Rating Scale | Scale assessing the perceived pain | From 1 month to the 3 months follow-up |
| Changes in Oswestry Disability Index | Validated questionnaire to assess the patient's disability | From enrollment to the 3 months follow-up |
| Changes in Oswestry Disability Index | Validated questionnaire to assess the patient's disability | 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 | From enrollment to the 1 month follow-up |
| Changes in Hospital Anxiety and Depression Scale | Validated questionnaire to assess the anxiety and depression | From enrollment to the 3 months follow-up |
| Changes in Hospital Anxiety and Depression Scale | Validated questionnaire to assess the anxiety and depression | From 1 month follow-up to the 3 months follow-up |
| Changes in Pain Self-Efficacy Questionnaire | Validated questionnaire to assess the self-efficacy | From enrollment to the 1 month follow-up |
| Changes in Pain Self-Efficacy Questionnaire | Validated questionnaire to assess the self-efficacy | From enrollment to the 3 months follow-up |
| Changes in Pain Self-Efficay Questionnaire | Validated questionnaire to assess the self-efficacy | 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 | From enrollment to the 3 months follow-up |
| Changes in Tampa Scale of Kinesiophobia | Validated questionnaire to assess the kinesiophobia | From enrollment to the 1 month follow-up |
| Changes in Tampa Scale of Kinesiophobia | Validated questionnaire to assess the kinesiophobia | From enrollment to the 3 months follow-up |
| Changes in Tampa Scale of Kinesiophobia | Validated questionnaire to assess the kinesiophobia | 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. | 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. | 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. | From 1 month follow-up to the 3 months follow-up |
| D009140 |
| Musculoskeletal Diseases |