Evaluation of Pain Relief and Functional Improvement After the Surgical Treatment for Low Back Pain Due to Degenerative Kyphoscoliosis - Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Change from the baseline clinical status at 1-3-6-12 months after the surgical treatment for degenerative scoliosis.
研究概览
简要总结
The study aims to analyze the surgical treatment of low back pain due to degenerative kyphoscoliosis, already routinely performed on patients treated in Istituto Ortopedico Rizzoli, in terms of reduction of the pain and functional improvement. The comparison of back pain and functional ability before and after the surgical treatment will be performed by administering to the patients specific questionnaires (Visual Analog Score VAS, Oswestry Disability Index ODI, Quality of Life EuroQoL 5D). Questionnaires administration will be matched to a purely objective and radiological assessment according to international guidelines. A psychological analysis will be also performed in order to evaluate co-morbidity from this field, considering that the concept of "shared decision-making" for the therapeutic approach to low back pain requires the evaluation of all these parameters.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male
- •Age 40-75 years
- •Patients capable of understanding and willing
- •Lumbar or thoraco-lumbar degenerative kyphoscoliosis
- •Chronic low back pain from more than 6 months and/or presence of neurological deficits at lower limbs
- •Failure to respond to conservative therapy
排除标准
- •Infections in place
- •Coagulation deficits
- •Serious psychological comorbidity
结局指标
主要结局
Change from the baseline clinical status at 1-3-6-12 months after the surgical treatment for degenerative scoliosis.
时间窗: Before surgery, 1-3-6-12 months after surgery, then annually
The clinical status of the patients will be evaluated before surgery and at 1-3-6-12 months of follow up (and then annually) by: 1. Visual Analog Scale (VAS); 2. Oswestry Disability Index (ODI); 3. Quality of life (EuroQoL 5D) test.
Change from the baseline radiographic status at 1-3-6-12 months after the surgical treatment for degenerative scoliosis.
时间窗: Before surgery, 1-3-6-12 months after surgery, then annually
The correction of the deformity with respect to the pre-operative status will be assessed by anteroposterior, bending and lateral full standing radiographs at 1-3-6-12 months of follow up (and then annually). Flexion/extension radiographs will be taken at 1-3-6-12 months after surgery in order to evaluate fusion and proper positioning of hardware. Successful arthrodesis (fusion) will be also confirmed by CT scan at 1 year. Criteria of fusion evaluation: 1. Fusion certain 2. Fusion likely 3. Status uncertain 4. Pseudo arthrosis likely 5. Pseudo arthrosis certain
Assessment of the psychological state of the patients before the surgical treatment and at 1-3-6-12 months of follow up.
时间窗: Before surgery, 1-3-6-12 months after surgery, then annually
The psychological state of the patients will be evaluate before the surgical treatment and at 1-3-6-12 months after surgery (then annually). To evaluate the psychological state of the patients the following questionnaires will be used: * STAI to evaluate the anxiety state * ZHUNG to evaluate the depressive state
次要结局
- Evaluation of possible surgical complications (hardware failure, neurological damages, re-intervention) during the perioperative period and at 1-3-6-12 months after surgery.(Perioperative, 1-3-6-12 months after surgery, then annually)