Randomized Controlled Trial to Investigate the Feasibility of a New Protocol for Treatment of Acute Low Back Pain and Sciatica From Lumbar Radiculopathy and Intervertebral Disc Herniation: Non-invasive Position-Induced Opening of the Intervertebral Foramen
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- Oswestry questionnaire
研究概览
简要总结
Efficiency of the conservative mechanical lumbosacral nerve root decompression, as an adjunct to pharmacological treatment, in the case of acute lumbosacral radiculopathy.
详细描述
Non-invasive Position-Induced Opening of the Intervertebral Foramen in sidelying position, as an adjunct to pharmacological treatment, was used in the case of acute lumbosacral radiculopathy.
20 examinees were split into two groups, 10 in the experimental and 10 in the control group. Experimental group was given positional opening of the intervert. foramen, together with pharmacological treatment - steroid antiinflammatory drug - dexamethasone, nonsteroid antiinflammatory drugs and pain killers while control group was given just the same pharmacological treatment and recommended rest.
Measured dependent variables were:
- Visual analogue pain scale (VAS) for the low back and radiculopathy, separately
- Straight leg raise in supine position - nerve mobility test
- EuroQol questionnaire - general health condition questionnaire
- Oswestry questionnaire - activities of daily living (ADL) specific questionnaire for low back pain and lumbosacral radiculopathies Inclusive criteria were: Age between 20 - 60, lumbar disc herniation recognized by the MRI, lumbosacral radiculopathy with symptoms such as radicular pain, sensation dysfunctions or motor dysfunctions, recognized by electromyography (EMG) diagnostics.
Exclusive criteria: age more than 60, degenerative lumbar stenosis, spondylolisthesis, vertebra fractures, tumours.
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
- Single (Participant)
盲法说明
Participants didn't know in which group they were allocated.
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20 - 60
- •Lumbar disc herniation proved by MRI
- •Lumbosacral radiculopathy with symptoms of radicular pain, sensation dysfunction, and motor dysfunction proved by EMG diagnostics.
排除标准
- •Age older than 60
- •Degenerative lumbar stenosis
- •Spondylolisthesis
- •Vertebrae fractures
- •Tumor metastasis
研究组 & 干预措施
Experimental
Physiotherapeutic non-invasive position-induced opening of the intervertebral foramen and pharmacological treatment with steroid antiinflammatory drugs - dexamethasone, nonsteroid antiinflammatory drugs and pain killers - tramadol.
干预措施: Physiotherapeutic, non-invasive position-induced opening of the intervertebral foramen (Procedure)
Control group
Pharmacological treatment with steroid antiinflammatory drugs - dexamethasone, nonsteroid antiinflammatory drugs and pain killers - tramadol.
干预措施: Physiotherapeutic, non-invasive position-induced opening of the intervertebral foramen (Procedure)
结局指标
主要结局
Oswestry questionnaire
时间窗: Change from baseline activity of daily living specific questionnaire for low back pain and lumbosacral radiculopathy subjectively reported value by Oswestry questionnaire compared to same values at discharge (mean value 8 days)
ADLs specific questionnaire for LBP and lumbosacral radiculopathy
Visual analogue pain scale for low back pain (LBP) Visual analogue scale for radiculopathy
时间窗: Change from baseline pain subjectively reported value by Visual Analogic Scale compared to same values at discharge (mean value 8 days)
Pain descriptor
Straight leg raise
时间窗: Change from baseline nerve mobility objectively reported value by straight leg raise compared to same values at discharge (mean value 8 days)
Nerve mobility test for lower lumbar nerve roots and n. ischiadicus
EuroQol questionnaire
时间窗: Change from baseline general health condition subjectively reported value by EuroQol questionnaire compared to same values at discharge (mean value 8 days)
General health condition questionnaire
次要结局
未报告次要终点
研究者
Sinisa Poznic
Master of Science in Physiotherapy
General Hospital Sveti Duh