Vacuum Myofascial Therapy Device and Physical Activity for the Treatment of Chronic Non-specific Low Back Pain. A Single Blind Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The intensity of pain: 10-point Numerical Pain Rating Scale
研究概览
简要总结
The term non-specific low back pain refers to the painful symptoms located in the lumbar region, which is delimited between the lower margin of the ribs and the lower limit of the buttocks
详细描述
This study aimed to investigate the efficacy of a vacuum myofascial therapy device (VT) for improving pressure pain thresholds (PPTs), functionality, range of motion (ROM), low back pain-related disability, pain, and quality of life in patients with non-specific low back pain. Methods: A randomized controlled trial in which participants with non-specific low back pain (NP) were randomly assigned to either an experimental (VT) or a comparison physical therapy program (PTP) group.
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
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed of Chronic Nonspecific Low Back Pain that do not improve with conventional physiotherapy or pharmacological therapy protocols.
- •Subjects who are in an active state of pain
排除标准
- •Individuals who have received surgery intervention in the spine
- •Individuals have received the proposed treatment in one month´s period previously.
- •Individuals who suffering from fibromialgia síndrome, cardiac patients with pacemakers, cancer, infectious processes, or generalized lymphedema.
- •Pregnant women can not receive this treatment intervention.
研究组 & 干预措施
Vacuum myofascial therapy and physical activity
The protocol would last 5 weeks, group received fifteen 30-minute sessions of vacuum myofascial therapy and fifteen sessions physical activity program similar to the control group per week.
干预措施: Vacuum myofascial therapy and physical activity program. (Procedure)
Physical activity Program
The exercise protocol would last 5 weeks, performing 3 exercise sessions per week, with an effective work time of 30 minutes per session. The exercises would be directly focused on activating the core stabilizing muscles.
干预措施: Physical activity program. (Other)
结局指标
主要结局
The intensity of pain: 10-point Numerical Pain Rating Scale
时间窗: Baseline
A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of shoulder pain, and the worst and lowest level of pain experienced in the preceding week in the shoulder area. The minimal clinically important difference (MCID) for the NPRS in patients with shoulder pain was 1.1 points (Mintken, Glynn, and Cleland 2009).
次要结局
- Roland Morris Disability Questionnaire(Baseline, immediately after treatment, four and twelve weeks)
- The intensity of pain: 10-point Numerical Pain Rating Scale(Immediately after the intervention , four and twelve weeks)
- Active range of motion of the lumbar spine(Baseline , immediately after treatment, four and twelve weeks)
- Pressure pain thresholds in trigger points(Baseline, immediately rafter treatment, four and twelve weeks)
- Questionnaire SF 12(Baseline, immediately after treatment, four and twelve weeks)
- OSWESTRY LOW BACK PAIN DISABILITY QUESTIONNAIRE(Baseline, immediately after treatment, four and twelve weeks)
研究者
Manuel Rodriguez Huguet
Clinical Professor
University of Cadiz