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

Not Applicable

Not yet recruiting

• Conditions: Spondylolisthesis

• Registration Number: NCT06799975
• Lead Sponsor: Istituto Clinico Humanitas

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-24
• Study First Submitted QC: 2025-01-24
• Last Update Submitted: 2025-01-24
• Study First Posted: 2025-01-29
• Last Update Posted: 2025-01-29
• Study Start: 2025-03-01
• Primary Completion: 2025-09
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in Oswestry Disability Index	From enrollment to the 1 month follow-up	Validated questionnaire to assess the patient's disability

Secondary Outcome Measures

Name	Time	Method
Changes in Numeric Rating Scale	From 1 month to the 3 months follow-up	Scale assessing the perceived pain
Changes in Oswestry Disability Index	From 1 month follow-up to the 3 months follow-up	Validated questionnaire to assess the patient's disability
Changes in Hospital Anxiety and Depression Scale	From 1 month follow-up to the 3 months follow-up	Validated questionnaire to assess the anxiety and depression
Changes in Pain Self-Efficacy Questionnaire	From enrollment to the 3 months follow-up	Validated questionnaire to assess the self-efficacy
Changes in Pain Self-Efficay Questionnaire	From 1 month follow-up to the 3 months follow-up	Validated questionnaire to assess the self-efficacy
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 1 month follow-up to the 3 months follow-up	Validated questionnaire to assess the kinesiophobia
Changes in Up and Walking Test	From 1 month follow-up to the 3 months 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.

Trial Locations

Locations (1)

Humanitas Research Hospital; 🇮🇹 Rozzano, Milan, Italy