Does Improvement Towards a Normal Cervical Sagittal Configuration Aid in the Management of Lumbosacral Radiculopathy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The Change in cervical absolute rotatory angle
研究概览
简要总结
A randomized controlled study with six months follow-up will be conducted to investigate the effects of sagittal head posture correction on 3D spinal posture parameters, back and leg pain, disability, and S1 nerve root function in patients with chronic discogenic lumbosacral radiculopathy . Participants will include 80 patients between 40 and 55 years experiencing chronic discogenic lumbosacral radiculopathy with a definite hypolordotic cervical spine and forward head posture and will be randomly assigned a comparative treatment control group and a study group. Both groups will receive TENS therapy and hot packs, additionally, the study group will receive the Denneroll cervical traction orthotic.
详细描述
Despite the fact that there is some evidence of a link between low back pain and head posture , there is limited experimental data to support a cause-and-effect relationship and interventional outcomes. Accordingly, a prospective, randomized, controlled study will be conducted at a research laboratory of our university to investigate if cervical curve restoration and forward head posture correction will have short and long term effects on three dimensional spinal posture parameters as well as lumbar radiculopathy management outcomes such as symptoms, disability, and neurophysiological findings .In this study we will use an orthotic cervical traction termed the Denneroll to help restore normal sagittal spinal configuration based on principles of 3-point bending traction methods. Interventions will be applied at a frequency of 3 times per week for 10 weeks and groups will be followed for an additional 6-months.
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
- None
入排标准
- 年龄范围
- 40 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Absolute rotatory angle less than 25° and greater than
- •Anterior head translation distance greater than 15mm
- •Confirmed chronic unilateral lumbosacral radiculopathy associated with L5-S1 lumbar disc prolapse .
- •Symptoms lasting longer than 3 months
排除标准
- •Previous history of lumbosacral surgery.
- •Metabolic system disorder.
- •Peripheral neuropathy.
- •History of upper motor neuron lesion.
- •Spinal canal stenosis.
- •Rheumatoid arthritis.
- •Osteoporosis
结局指标
主要结局
The Change in cervical absolute rotatory angle
时间窗: will be measured at three intervals :pretreatment, 10 weeks post treatment, and at six months of follow-up
Cervical absolute rotatory angle is formed by two lines intersecting from the posterior body margins of C2-C7 and forward head distance
The Change in anterior head translation
时间窗: will be measured at three intervals :pretreatment, 10 weeks post treatment, and at six months of follow-up
anterior head translation is measured as the horizontal displacement of the posterior superior body corner of C2 vertebra relative to a vertical line extending superiorly from the posterior inferior body corner of C7..
次要结局
- The change in 3D spinal posture parameters(will be measured at three intervals :pretreatment, 10 weeks post treatment, and at six months of follow-up)
- The change in pain intensity(will be measured at three intervals :pretreatment, 10 weeks post treatment, and at six months of follow-up)
- The change in disability level(will be measured at three intervals :pretreatment, 10 weeks post treatment, and at six months of follow-up)
- The change in peak to peak amplitude of H reflex(will be measured at three intervals :pretreatment, 10 weeks post treatment, and at six months of follow-up)
研究者
Ibrahim Moustafa
Professor-chair of Physiotherapy Department
Cairo University