Effectiveness of Neural Mobilization Techniques Compared to Standard Care Treatment in Patients With Lumbar Radiculitis: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 130
- 主要终点
- Visual Analogue Scale (VAS) - Measure assessing change
研究概览
简要总结
The purpose of this study is to determine the effectiveness of neural mobilization techniques compared to standard care treatment in patients with lumbar radiculitis.
详细描述
Background:
Radicular pain has been regarded as a distinct pain entity as its pathophysiology differs from that of somatic referred pain and nociceptive pain. Radicular lumbar pain describes sensitized nerve roots of the lumbar spine or peripheral nerve trunks that are capable of producing pain (usually below the knee) and/or other symptoms in the absence of true nerve tissue damage. This type of pain is evoked by ectopic discharges stemming from lumbar dorsal roots or their ganglions. The most common causes for this type of pain is the inflammatory environment that is produced by substances contained in the herniated material of injured lumbar intervertebral discs.
It has been suggested that patients presenting with functional (e.g. mechanosensitivity) but not structural nerve root problems, can be identified through screening and further classified as a discrete group of patients that benefit from specific neural mobilization techniques.
Neural mobilization techniques have gained considerable amount of attention amongst therapists and researchers for the assessment and treatment of painful conditions that occasionally involve a neural element in their pathophysiology such as lumbar radicular pain. Studies exploring the effect of neural mobilization techniques on patients with lumbar radicular pain have generally shown good results but they are lacking in adequate sample size and methodological quality.
The aim of this study is to compare the effectiveness of neural mobilization techniques to standard care physiotherapy treatment (ultrasound, general exercises, massage therapy, transcutaneous electrical nerve stimulation) in patients with lumbar radiculitis.
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)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with low back pain and pain that radiates in the lower limb
- •Duration of symptoms > 6 weeks
- •Patients willing to be reassessed after 6 months
- •Patients willing to give written informed consent
排除标准
- •History of spinal surgery
- •History of surgery or injury in the lower limbs in the past 6 months
- •Signs and symptoms of central nervous system involvement
- •Nerve root blocks for the past 6 weeks
- •History of diabetes
- •History of polyneuropathies
- •History of vascular pathologies in the lower limbs
- •History of systemic pathologies
- •History of inflammatory arthropathies
结局指标
主要结局
Visual Analogue Scale (VAS) - Measure assessing change
时间窗: Change from baseline after 5 weeks and at 6 months
The VAS is a 100-point pain assessment scale ranging from 0 (no pain) to 100 (worst pain possible).
次要结局
- Roland Morris Disability Questionnaire (RMDQ) - Measure assessing change(Change from baseline after 5 weeks and at 6 months)
- Fear Avoidance and Beliefs Questionnaire (FABQ) - Measure assessing change(Change from baseline after 5 weeks and at 6 months)
- Handheld dynamometer - Measure assessing change(Change from baseline after 5 weeks and at 6 months)
研究者
Michalis Efstathiou
Assosiate Lecturer
University of Nicosia