Clinical trial NCT06799975: Effects of a Single Session of Physiotherapy on Patients Operated for Lumbar Spondylolisthesis
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spondylolisthesis
Keywords: lumbar spondylolisthesis
physiotherapy
disability
psychological factors
randomized controlled trial
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in Oswestry Disability Index
timeFrame: From enrollment to the 1 month follow-up
Secondary outcomes:
measure: Changes in Numeric Rating Scale
timeFrame: From enrollment to the 1 month follow-up
measure: Changes in Numeric Rating Scale
timeFrame: From enrollment to the 3 months follow-up
measure: Changes in Numeric Rating Scale
timeFrame: From 1 month to the 3 months follow-up
measure: Changes in Oswestry Disability Index
timeFrame: From enrollment to the 3 months follow-up
measure: Changes in Oswestry Disability Index
timeFrame: From 1 month follow-up to the 3 months follow-up
measure: Changes in Hospital Anxiety and Depression Scale
timeFrame: From enrollment to the 1 month follow-up
measure: Changes in Hospital Anxiety and Depression Scale
timeFrame: From enrollment to the 3 months follow-up
measure: Changes in Hospital Anxiety and Depression Scale
timeFrame: From 1 month follow-up to the 3 months follow-up
measure: Changes in Pain Self-Efficacy Questionnaire
timeFrame: From enrollment to the 1 month follow-up
measure: Changes in Pain Self-Efficacy Questionnaire
timeFrame: From enrollment to the 3 months follow-up
measure: Changes in Pain Self-Efficay Questionnaire
timeFrame: From 1 month follow-up to the 3 months follow-up
measure: Changes in Short Form Health Survey 36
timeFrame: From enrollment to the 3 months follow-up
measure: Changes in Tampa Scale of Kinesiophobia
timeFrame: From enrollment to the 1 month follow-up
measure: Changes in Tampa Scale of Kinesiophobia
timeFrame: From enrollment to the 3 months follow-up
measure: Changes in Tampa Scale of Kinesiophobia
timeFrame: From 1 month follow-up to the 3 months follow-up
measure: Changes in Up and Walking Test
timeFrame: From enrollment to the 1 month follow-up
measure: Changes in Up and Walking Test
timeFrame: From enrollment to the 3 months follow-up
measure: Changes in Up and Walking Test
timeFrame: From 1 month follow-up to the 3 months follow-up
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Humanitas Research Hospital
state: Milan
Study officials:
References: