Effects of a Single Session of Physiotherapy on Patients Operated for Lumbar Spondylolisthesis

NCT ID: NCT06799975

Last Updated: 2025-01-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2025-12-31

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.

Conditions

Spondylolisthesis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Education

The intervention consists of a single physiotherapy session before discharge.

Group Type: EXPERIMENTAL

Education

Intervention Type: 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).

Usual care

Usual discharge procedures

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: 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.

Interventions

Education

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).

Intervention Type: OTHER

Usual 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Clinico Humanitas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Humanitas Research Hospital

Rozzano, Milan, Italy

Countries

Italy

Central Contacts

Roberto Gatti

Role: CONTACT

roberto.gatti@hunimed.eu

0282245610

Ali Baram

Role: CONTACT

ali.baram@humanitas.it

Facility Contacts

Roberto Gatti

Role: primary

roberto.gatti@hunimed.eu

0282245610

Other Identifiers

CLF23/00

Identifier Type: -

Identifier Source: org_study_id