Whole-Body Electromyostimulation Versus Medical Therapeutic Training (MTT) Resistance Exercise for the Treatment of Non-Specific Chronic Low Back Pain in Middle-Aged to Older Cohort With Low-Back Pain.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Changes of non-specific low back pain from baseline to 10 week follow-up assessment as determined by the numeric rating scale 0-10
研究概览
简要总结
Non-specific chronic low back pain (NSCBP) is considered the leading cause of impairment of normal, symptom-free life (disability-adjusted life years - DALYs). NSCBP force more people out of work than diabetes, heart disease, hypertension, respiratory disease, asthma and cancer together. Strength and stability-oriented training programs in particular can lead to a significant improvement in NSCBP. However, back pain patients often cite time limitations and kinesiophobia (fear of movements) as the main reasons for their physical inactivity . The time-effective, joint-friendly and highly customizable whole-body electromyostimulation technology (WB-EMS) has been shown to be an effective alternative to conventional back training in two recently published clinical studies Following the successful implementation of this concept, dissemination of the positive results and testing of suitable settings for its implementation, the next step is to adapt and implement the concept as part of a knowledge transfer project in outpatient rehabilitation settings. The present project thus aimed to compare the effect of WB-EMS versus medical therapeutic therapy (MTT) using dedicated resistances devices as a recognized safe and effective treatment for low back pain.
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)
盲法说明
Outcome assessors are unaware of participant status (WB-EMS or MTT) and were not allowed to ask participants correspondingly
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •women and men 40-70 years old;
- •chronic pain in the lumbar spine (at least 50 percent of the days of the last 3 months,
- •average basal pain intensity (average 7 days) in the lumbar spine on NRS 0-10: ≥2.5
排除标准
- •orthopedic diagnosis (i.e. specific type of LBP);
- •frequent intake of analgesics (>4 days/week);
- •pharmacological therapy or diseases affecting muscle metabolism (e.g., glucocorticoids);
- •no contraindications for WB-EMS application (e.g., epilepsy, cardiac pacemaker, thrombosis, and total endoprosthesis)
研究组 & 干预措施
Whole-body electromyostimulation
WB-EMS 1.5x 20 min/week for 10 weeks
干预措施: Whole-body electrostimulation (Other)
Medical training therapy (MTT)
MTT 2x 45 min/week for 10 weeks
干预措施: Medical Training Therapy (Other)
结局指标
主要结局
Changes of non-specific low back pain from baseline to 10 week follow-up assessment as determined by the numeric rating scale 0-10
时间窗: From enrollment (baseline assessment) to the end of treatment at 10 weeks"
Numeric rating scale 1-10: Zero is equivalent to no pain and 10 indicates the worst possible pain."
次要结局
- Changes of disability from baseline to 10 week follow-up assessment as determine by the Roland Morris Disability Questionnaire (RMDQ)(From enrollment (baseline) to the end of treatment at 10 weeks")
- Changes of trunk flexion strength from baseline to 10 week follow-up assessment as determined by the Dr. Wolf back-check device(From enrollment (baseline assessment) to the end of treatment at 10 weeks")
- Changes of lean body mass from baseline to 10 week assessment as determined by bio impedance assessment (BIA)(From enrollment (baseline assessment) to the end of treatment at 10 weeks)
- Changes of back extension strength from baseline to 10 week follow-up assessment as determined by the Dr. Wolf back-check device("From enrollment (baseline assessment) to the end of treatment at 10 weeks")
- Changes of body fat from baseline to 10 week follow-up assessment as determine by bio impedance analysis(From enrollment (baseline assessment) to the end of treatment at 10 weeks)