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临床试验/NCT06642350
NCT06642350
已完成
不适用

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.

University of Erlangen-Nürnberg Medical School1 个研究点 分布在 1 个国家目标入组 26 人2024年7月1日

概览

阶段
不适用
干预措施
Whole-body electrostimulation
疾病 / 适应症
Low Back Pain
发起方
University of Erlangen-Nürnberg Medical School
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
状态
已完成
最后更新
3个月前

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.

注册库
clinicaltrials.gov
开始日期
2024年7月1日
结束日期
2025年3月31日
最后更新
3个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
University of Erlangen-Nürnberg Medical School
责任方
Sponsor

入排标准

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

Medical training therapy (MTT)

MTT 2x 45 min/week for 10 weeks

干预措施: Medical Training Therapy

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)

研究点 (1)

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