Rehabilitative Therapy and Pridinol in Patients With Lumbar Spondylarthrosis and Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Extent of pain: Numeric Rating Scale (NRS 0-10)
研究概览
简要总结
Spondyloarthrosis is a degenerative disease involving the intervertebral disc, vertebral bodies, and adjacent soft tissues. Treatment aims to slow disease progression and manage symptoms through an interdisciplinary approach.It can be conservative, pharmacological and interventional, rarely chirurgic. This study aimed to evaluate the effectiveness of a rehabilitation program combined with Pridinol Mesylate in the treatment of Spondyloarthrosis in elderly patients in terms of pain resolution, improving disability, and quality of life versus single treatment.
A randomized controlled trial was conducted in patients with spondyloarthritis. The patients recruited were divided into three groups: the Combined Group (CG), who received a rehabilitation program combined with Pridinol Mesylate; the Rehabilitation Group (RG), who received only the same rehabilitation program; and the Drug Group (DG), who received only the administration of the drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 75 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 65-75 years,
- •low back pain for at least 3 months,
- •radiographic diagnosis of spondyloarthrosis,
- •written informed consent.
排除标准
- •inflammatory diseases of the spine,
- •obesity (BMI 20-30),
- •positive radicular tests,
- •allergy or contraindications related to taking Pridinol Mesylate.
结局指标
主要结局
Extent of pain: Numeric Rating Scale (NRS 0-10)
时间窗: at recruitment (T0), after 20 days of treatment (T1), after 90 days from recruitment (T2)
The NRS is a subjective scale that rates the extent of pain with a score between 0 and 10; a score of 10 corresponds to maximum pain.
次要结局
- Disability: Quebec Back Pain Disability Scale (QBPDS scale 0-100)(at recruitment (T0), after 20 days of treatment (T1), after 90 days from recruitment (T2))
- Quality of life: Short Form Health Survey 36 (0-100)(at recruitment (T0), after 20 days of treatment (T1), after 90 days from recruitment (T2))
研究者
Prof.ssa Giulia Letizia Mauro
Professor
University of Palermo