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NCT Number: NCT06799975

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

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.

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Key information

Conditions

Spondylolisthesis Bone Diseases Musculoskeletal Diseases Spinal Diseases Spondylolysis Spondylosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Education

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

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.

Primary outcomes

  1. Changes in Oswestry Disability Index

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

    Validated questionnaire to assess the patient's disability

Secondary outcomes

  1. Changes in Numeric Rating Scale

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

    Scale assessing the perceived pain

  2. Changes in Numeric Rating Scale

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

    Scale assessing the perceived pain

  3. Changes in Numeric Rating Scale

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

    Scale assessing the perceived pain

  4. Changes in Oswestry Disability Index

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

    Validated questionnaire to assess the patient's disability

  5. Changes in Oswestry Disability Index

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

    Validated questionnaire to assess the patient's disability

  6. Changes in Hospital Anxiety and Depression Scale

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

    Validated questionnaire to assess the anxiety and depression

  7. Changes in Hospital Anxiety and Depression Scale

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

    Validated questionnaire to assess the anxiety and depression

  8. Changes in Hospital Anxiety and Depression Scale

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

    Validated questionnaire to assess the anxiety and depression

  9. Changes in Pain Self-Efficacy Questionnaire

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

    Validated questionnaire to assess the self-efficacy

  10. Changes in Pain Self-Efficacy Questionnaire

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

    Validated questionnaire to assess the self-efficacy

  11. Changes in Pain Self-Efficay Questionnaire

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

    Validated questionnaire to assess the self-efficacy

  12. Changes in Short Form Health Survey 36

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

    Validated questionnaire to assess the quality of life

  13. Changes in Tampa Scale of Kinesiophobia

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

    Validated questionnaire to assess the kinesiophobia

  14. Changes in Tampa Scale of Kinesiophobia

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

    Validated questionnaire to assess the kinesiophobia

  15. Changes in Tampa Scale of Kinesiophobia

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

    Validated questionnaire to assess the kinesiophobia

  16. Changes in Up and Walking Test

    Time frame: From enrollment to the 1 month 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.

  17. Changes in Up and Walking Test

    Time frame: From enrollment 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.

  18. Changes in Up and Walking Test

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ali Baram

CONTACT

[email protected]

Roberto Gatti

CONTACT

[email protected]

0282245610

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 29, 2025
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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