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临床试验/NCT02664688
NCT02664688已完成不适用

Lumbar Stabilization Exercises vs Flexor Exercises in Patients With Chronic Low Back Pain and Degenerative Spondylolisthesis

Instituto Nacional de Rehabilitacion2 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2015年7月最近更新:
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
92
试验地点
2
主要终点
Change in Pain (VAS)

研究概览

简要总结

The purpose of this study is to compare the effectiveness of pain control and functional improvement in patients with degenerative spondylolisthesis treated with "lumbar stabilization exercises" vs "flexor exercises (williams exercises)"

详细描述

This study is a randomized controlled trial in patients with the diagnosis of degenerative spondylolisthesis.

To date, it is known that lumbar stabilization exercises are an effective treatment option in controlling pain and improving function in patients with degenerative spondylolisthesis based on previous studies, but it is not known if is this a better treatment that another exercises routine for chronic LBP (Low Back Pain).

The purpose is to compare the effectiveness on pain control and functional improvement of "lumbar stabilization exercises" vs "flexor exercises (williams exercises)".

All clinical evaluations are performed by a single physician who is blinded to the exercises, and include a full medical history, physical examination, and x-ray measurement.

After initial evaluation, patients are given a sealed envelope containing the treatment (by simple randomization assigned by the investigator). The envelope is opened by the physical therapist which schedules a monthly session and verify the correct execution of each exercise. Each patient receives a sheet with instructions of the exercises to continue daily at home.

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 (Outcomes Assessor)

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Degenerative spondylolisthesis at L4-L5 and chronic LBP with or without radicular pain
  • Attending the Spinal Rehabilitation Service of the National Institute for Rehabilitation (Mexico City).
  • Without previous treatment
  • Agree to participate through informed consent.

排除标准

  • History of lumbar surgery,
  • Rheumatic diseases: Rheumatoid Arthritis, Lupus Erythematosus Systemic, Fibromyalgia, etc.
  • Cauda equine symptoms,
  • Ischemic heart disease
  • Diabetic polyneuropathy
  • Illiterate

研究组 & 干预措施

Lumbar stabilization exercises

Experimental

Home exercise program to perform daily for 6 months

干预措施: Lumbar stabilization exercises (Other)

Flexor Exercises

Active Comparator

Home exercise program to perform daily for 6 months

干预措施: Flexor exercises (Other)

结局指标

主要结局

Change in Pain (VAS)

时间窗: At baseline, 4 weeks, 3 months and 6 months

Visual Analog Scale (VAS), considering "no pain" to be at 0mm, and 100mm to be "unbearable pain."

Change in Disability (The Roland Morris Scale)

时间窗: At baseline, 4 weeks, 3 months and 6 months

The Roland Morris Scale: a self-administered questionnaire consisting of 24 items. The total score can range from 0 (no disability) to 24 (maximum disability)

次要结局

  • Change in use of analgesics(At baseline, 4 weeks, 3 months and 6 months)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Tania Ines Nava-Bringas

MSc; MD

Instituto Nacional de Rehabilitacion

研究点 (2)

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