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

Istituto Clinico Humanitas

Status: Not yet enrolling

Conditions: Spondylolisthesis

Treatments: Other: Usual Care; Other: Education

Study type: Interventional

Funder types: Other

Identifiers

NCT06799975

CLF23/00

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Education

Experimental group

Description:

The intervention consists of a single physiotherapy session before discharge.

Treatment:

Other: Education

Usual care

Active Comparator group

Description:

Usual discharge procedures

Treatment:

Other: Usual Care