Spondylolisthesis
Conditions
Keywords
lumbar spondylolisthesis, physiotherapy, disability, psychological factors, randomized controlled trial
Brief 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. 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.
Interventions
OTHEREducation
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).
OTHERUsual Care
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.
Sponsors
Istituto Clinico Humanitas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The assessor was unaware of the participant's intervention group, as was the investigator.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Patients who have undergone lumbar fusion surgery due to monosegmental lumbar spondylolisthesis.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Oswestry Disability Index | From enrollment to the 1 month follow-up | Validated questionnaire to assess the patient's disability |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Oswestry Disability Index | From enrollment to the 3 months follow-up | Validated questionnaire to assess the patient's disability |
| Changes in Hospital Anxiety and Depression Scale | From enrollment to the 1 month follow-up | Validated questionnaire to assess the anxiety and depression |
| Changes in Pain Self-Efficacy Questionnaire | From enrollment to the 1 month follow-up | Validated questionnaire to assess the self-efficacy |
| Changes in Numeric Rating Scale | From enrollment to the 1 month follow-up | Scale assessing the perceived pain |
| Changes in Short Form Health Survey 36 | From enrollment to the 3 months follow-up | Validated questionnaire to assess the quality of life |
| Changes in Tampa Scale of Kinesiophobia | From enrollment to the 1 month follow-up | Validated questionnaire to assess the kinesiophobia |
| Changes in Up and Walking Test | From enrollment to the 1 month follow-up | 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. |
| Changes in Pain Self-Efficay Questionnaire | From 1 month follow-up to the 3 months follow-up | Validated questionnaire to assess the self-efficacy |
Countries
Italy
Contacts
Primary ContactRoberto Gatti
Backup ContactAli Baram
Outcome results
None listed