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

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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 cl
• Другое 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.

Первичные конечные точки

• Changes in Oswestry Disability Index [Срок оценки: From enrollment to the 1 month follow-up]

Вторичные конечные точки (12)

• Changes in Numeric Rating Scale [Срок оценки: From enrollment to the 1 month follow-up]
• Changes in Numeric Rating Scale [Срок оценки: From enrollment to the 3 months follow-up]
• Changes in Numeric Rating Scale [Срок оценки: From 1 month to the 3 months follow-up]
• Changes in Oswestry Disability Index [Срок оценки: From enrollment to the 3 months follow-up]
• Changes in Oswestry Disability Index [Срок оценки: From 1 month follow-up to the 3 months follow-up]
• Changes in Hospital Anxiety and Depression Scale [Срок оценки: From enrollment to the 1 month follow-up]
• Changes in Hospital Anxiety and Depression Scale [Срок оценки: From enrollment to the 3 months follow-up]
• Changes in Hospital Anxiety and Depression Scale [Срок оценки: From 1 month follow-up to the 3 months follow-up]
• Changes in Pain Self-Efficacy Questionnaire [Срок оценки: From enrollment to the 1 month follow-up]
• Changes in Pain Self-Efficacy Questionnaire [Срок оценки: From enrollment to the 3 months follow-up]
• Changes in Pain Self-Efficay Questionnaire [Срок оценки: From 1 month follow-up to the 3 months follow-up]
• Changes in Short Form Health Survey 36 [Срок оценки: From enrollment to the 3 months follow-up]

Критерии участия

Критерии включения

• Age > 18 years
• Patients who have undergone lumbar fusion surgery due to monosegmental lumbar spondylolisthesis.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Humanitas Research Hospital — Rozzano

Идентификаторы

NCT: NCT06799975 · CLF23/00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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