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临床试验/NCT04043611
NCT04043611已完成不适用

Effect of Elongation Longitudinaux Avec Decoaption Osteo-Articulaire Exercises in Lumbar Disc Protrusion

Riphah International University2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2019年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
2
主要终点
Range of Motion (ROM) Lumbar Spine (Flexion)

研究概览

简要总结

The aim of this randomized controlled trial will be to determine the effectiveness of ELDOA for treating lumbar disc protrusion. Two randomized groups of patients with lumbar disc protrusion will be treated with conservative physical therapy and the experimental group will be given ELDOA, in addition. Both, male and female patients meeting the inclusion criteria will be included. Patients having concurrent malignancy, infection, trauma or any bony deformity will be excluded

详细描述

The study is aimed at determining the effects of ELDOA in treating disc protrusion at lumbar region and is being conducted in Max Rehab & Physical Therapy Centre Islamabad and Pakistan Railway General Hospital, Rawalpindi (March 2019-June 2019). Sample size of the study is 34 with confidence interval of 95% and power of 0.8. 30 patients were screened and 29 were included in the study on the basis of inclusion criteria. Sealed envelope contained total 34 questionnaires, 17 for each group. Patients were allocated randomly on the basis of group mentioned on the Performa. Similar conservative rehabilitation protocol was designed for both control and experimental group except for experimental group had ELDOA Exercises in addition. Patients were examined at 1st visit before administration of any treatment and at 4th visit which was also the last one (after completing 4 sessions at alternate days). Baseline evaluation for demographics and symptomatology was taken. Self-reported questionnaire, ODI, NPRS, lumbar ROM and SLR were recorded at first and fourth visit for comparison. 26 patients completed the study while 1 patient from control group and 2 patients from experiment group were lost to follow up and were considered drop outs.

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
30 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Limited ROM (hip/lumbar spine)
  • Pain more than 3 on NPRS
  • Pain ≥ 3 months

排除标准

  • Recurrent disc protrusion
  • Spondylolisthesis
  • Spondylosis
  • Malignancy
  • Infection
  • Marked bony deformities

研究组 & 干预措施

ELDOA

Experimental

Conservative physical therapy management + ELDOA positions

干预措施: ELDOA (Other)

Conservative physical therapy management

Active Comparator

Tens and hot pack , Soft tissue mobilization , Maitland's Lumbar segmental mobilization, Traction, Neurodynamics, Active Stretching, McKenzie Prone Extension Exercises

干预措施: Conservative physical therapy management (Other)

结局指标

主要结局

Range of Motion (ROM) Lumbar Spine (Flexion)

时间窗: 4th day

Changes from the Baseline, ROM of lumbar spine flexion was taken with the help of inclinometer

ROM Lumbar Spine (extension)

时间窗: 4th day

ROM of Lumbar spine extension was taken with the help of inclinometer

Straight Leg Raising (SLR)

时间窗: 4th day

Straight Leg Raising range was taken with the help of inclinometer

Oswestry disability index

时间窗: 4th day

Changes from the Baseline, Oswestry disability index (ODI) was developed in order to assess disability related to pain in individuals with acute, sub-acute, or chronic LBP. The total score of ODI range from 0 (no disability) to 100 (maximum disability). Scores from 0-20 to indicate "minimal disability," 20-40 to indicate "moderate disability," 40-60 to indicate "severe disability," 60-80 to indicate "housebound," and 80-100 to indicate "bedbound". The ODI score is recommended as a back pain-specific measure of disability.

Numeric Pain rating scale

时间窗: 4th day

Changes from the Baseline, Numeric Pain rating scale (NPRS) is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain.

ROM Lumbar Spine (Right side flexion)

时间窗: 4th day

ROM of Lumbar spine right side flexion was taken with the help of inclinometer

ROM Lumbar Spine (left side Flexion)

时间窗: 4th day

ROM of Lumbar spine left side flexion was taken with the help of inclinometer

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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