Non-surgical Spinal Decompression in Patients with Chronic Low Back Pain and Sciatica: a 2-month Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Pain intensity
研究概览
简要总结
The goal of this quasi-experimental trial was to evaluate the effects of non-surgical spinal decompression on disability and pain in patients with chronic low back pain and sciatica throughout a two-month follow-up, and to analyze the relationship between demographic factors and clinical outcomes after a program of non-surgical spinal decompression.
The main questions it aims to answer were:
- Non-surgical spinal decompression is effective to reduce pain intensity and self-reported disability in patients with chronic low back pain and sciatica?
- Age, level of education and work activities are related with clinical outcome in patients treated with non-surgical spinal decompression?
Participants underwent eight sessions, three per week, with the BTL-6000 spinal decompression system. The study did not have a comparison group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 55 years old.
- •Chronic (at least six months) low back pain (LBP) and/or sciatica.
- •Abnormalities of intervertebral disc on magnetic resonance imaging (MRI).
排除标准
- •Patients with prior spine surgery.
- •Vertebral instability.
- •Current infectious disease.
- •Pregnancy.
- •Kinesiophobia.
- •Fibromyalgia.
研究组 & 干预措施
Patients treated with non-surgical spinal decompression
The patients were positioned in supine with adjustable lumbar, and thoracic belts attached to the traction cord. After tightening the belts, the M7 position was selected to achieve hip and knee flexion, and posterior pelvic tilt of 25° was added. Before starting the therapy, the weight of the subject was entered in the panel, and a short tolerance test was carried out. Patients were provided with a manual switch to stop treatment any time. Preset lumbar disc herniation protocol was used. Each session lasted fifteen minutes, applied force had 100-gram step increments, and did not exceed 50% of the weight of the patient. At the end of the therapy, the cord was disconnected and belts were removed. Participants were asked to sit for three minutes to identify any adverse reaction.
干预措施: Spinal decompression with BTL-6000 spinal decompression system (BTL Industries Ltd.) (Device)
结局指标
主要结局
Pain intensity
时间窗: Baseline, at the end of the eighth session, and at 2nd-month follow-up.
Pain intensity was also evaluated with the numeric pain rating scale (NPRS), a popular clinical tool consisting of a numbered straight line from zero (no pain) to ten (the worst pain), where the patients registered their current pain intensity.
Self-reported disability
时间窗: Baseline, at the end of the eighth session, and at 2nd-month follow-up.
We measured self-reported disability associated with spine disorders through the spanish version of the Oswestry Disability Index (ODI), a reliable and validated instrument composed by ten sections (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and traveling), in which the patient grades the disability from zero (no limitation) to five (limitation prevents me from performing the activity). The ODI final score was calculated with the following formula: \[total score/(5 x number of answered questions)\] x 100%, and interpreted as the higher the score, the greater the disability.
次要结局
未报告次要终点
研究者
Armando Tonatiuh Avila Garcia
Chief Department of Physical Medicine and Rehabilitation
Hospital Civil de Guadalajara