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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIstituto Clinico Humanitas

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Age > 18 years

Patients who have undergone lumbar fusion surgery due to monosegmental lumbar spondylolisthesis.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Education

    Other intervention

    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

    Other intervention

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: EducationExperimental treatment 1 intervention
Group B: Usual careActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Changes in Oswestry Disability Index

Validated questionnaire to assess the patient's disability

Time frame
From enrollment to the 1 month follow-up

Secondary outcomes

1

Changes in Numeric Rating Scale

Scale assessing the perceived pain

Time frame
From enrollment to the 1 month follow-up
2

Changes in Numeric Rating Scale

Scale assessing the perceived pain

Time frame
From enrollment to the 3 months follow-up
3

Changes in Numeric Rating Scale

Scale assessing the perceived pain

Time frame
From 1 month to the 3 months follow-up
4

Changes in Oswestry Disability Index

Validated questionnaire to assess the patient's disability

Time frame
From enrollment to the 3 months follow-up

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: