NCT06799975

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

Effects of a Single Session of Physiotherapy on Pain, Disability and Psychological Risk Factors in Patients Operated for Lumbar Spondylolisthesis: a Randomized Controlled Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	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).
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.

Timeline

• Start date: 2025-03-01
• Primary completion: 2025-09-01
• Completion: 2025-12-01
• First posted: 2025-01-29
• Last updated: 2025-01-29

Locations

1 site across 1 country: Italy