Lumbar Stabilization Exercises vs Flexor Exercises in Patients With Chronic Low Back Pain and Degenerative Spondylolisthesis
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
- 否
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
Home exercise program to perform daily for 6 months
干预措施: Lumbar stabilization exercises (Other)
Flexor Exercises
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
Tania Ines Nava-Bringas
MSc; MD
Instituto Nacional de Rehabilitacion
