High Versus Low Level of Lumbar Traction in Acute Lumbar Sciatica Due to Disc Herniation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Change in radicular pain graduated from 0 to 100 mm
研究概览
简要总结
The aim of this study is to compare two levels (high and low forces) of short term lumbar traction on pain and functional tests of the lower limbs in a specific population of patients presenting with acute lumbar sciatica secondary to disc herniation. The investigators hypothesize that, in this particular medical condition, high level of lumbar traction might be more effective than low level lumbar traction in decreasing the pain associated with acute sciatica.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •less than 6-week lumbar sciatica secondary to disc herniation, confirmed by pain radiating down the leg along the distribution of the sciatic nerve together with positive straight leg raising test (SLRT)
排除标准
- •symptoms persisting for more than 6 weeks
- •signs of clinical neurological deficit
- •lumbar sciatica not caused by disc herniation
- •presence of lumbar tomodensitometry abnormalities
- •Subjects younger than 18
- •pregnant women
- •patients on medical leave for more than 3 weeks at inclusion
- •patients with history of lumbar surgery
- •patients who already had lumbar traction therapy
研究组 & 干预措施
LT10
Long duration (30 minutes) traction sessions of "low force" (10% of body weight) for 2 weeks (5 sessions/week).
干预措施: Traction sessions (Procedure)
LT50
Long duration (30 minutes) traction sessions of "high force" (50% of body weight) for 2 weeks (5 sessions/week).
干预措施: Traction sessions (Procedure)
结局指标
主要结局
Change in radicular pain graduated from 0 to 100 mm
时间窗: Measurement of radicular pain using a visual analogue scale (VAS) At baseline (day 0 - D0) as well as at day 14 (D14) (end of treatment) and day 28 (D28) (after 2 weeks follow-up).
次要结局
- Signs of nerve root compression evaluation assessed by the SLRT and EIFEL score(At baseline (day 0 - D0) as well as at day 14 (D14) (end of treatment) and day 28 (D28) (after 2 weeks follow-up).)
- Global mobility of the lumbar-pelvic spine evaluated using the finger to toe test (FTT, in cm)(At baseline (day 0 - D0) as well as at day 14 (D14) (end of treatment) and day 28 (D28) (after 2 weeks follow-up).)
- Lumbar spine mobility (in mm) assessed with the Schöber-Macrae's test(At baseline (day 0 - D0) as well as at day 14 (D14) (end of treatment) and day 28 (D28) (after 2 weeks follow-up).)