Effects of a Single Session of Physiotherapy on Pain, Disability and Psychological Risk Factors in Patients Operated for Lumbar Spondylolisthesis: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Changes in Oswestry Disability Index
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The assessor was unaware of the participant's intervention group, as was the investigator.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Patients who have undergone lumbar fusion surgery due to monosegmental lumbar spondylolisthesis.
排除标准
- •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
结局指标
主要结局
Changes in Oswestry Disability Index
时间窗: From enrollment to the 1 month follow-up
Validated questionnaire to assess the patient's disability
次要结局
- Changes in Numeric Rating Scale(From 1 month to the 3 months follow-up)
- Changes in Oswestry Disability Index(From 1 month follow-up to the 3 months follow-up)
- Changes in Hospital Anxiety and Depression Scale(From 1 month follow-up to the 3 months follow-up)
- Changes in Pain Self-Efficacy Questionnaire(From enrollment to the 3 months follow-up)
- Changes in Pain Self-Efficay Questionnaire(From 1 month follow-up to the 3 months follow-up)
- Changes in Short Form Health Survey 36(From enrollment to the 3 months follow-up)
- Changes in Tampa Scale of Kinesiophobia(From 1 month follow-up to the 3 months follow-up)
- Changes in Up and Walking Test(From 1 month follow-up to the 3 months follow-up)