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临床试验/NCT02122445
NCT02122445已完成不适用

Effectiveness of Cramer Sports Motion Tape on Low Back Pain Patients' Pain and Muscle Activation

Sport and Spine Rehab Clinical Research Foundation2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Percent of Maximal Voluntary Isometric Contraction (%MVIC)

研究概览

简要总结

Low back pain is a problem which affects up to 70-80% of people in their lifetime. In the United States, it is estimated that the total direct and indirect costs of low back pain combined ranges from $19.6 to $118.8 billion. Recent studies have shown the importance of the gluteal musculature in the treatment of low back pain. It was found that the gluteus maximus (Gmax) is significantly more active in a low back pain population compared to a healthy population, indicating the low back pain population relied on the Gmax to fire more to overcome the gluteal weakness. A new approach to treating musculoskeletal conditions is a taping technique designed to target muscles and lymphatic system. Limited research is available for the treatment of specific conditions, including low back pain, but it is theorized to inhibit or facilitate the muscle, improve blood flow, reduce pain, and improve joint alignment. Methods: The purpose of this study is to determine the immediate and delayed effectiveness of Cramer® Sports Motion Tape on Gmax and lumbar paraspinal activation in a chronic mechanical low back pain population. A convenience sample of 20 new patients with current, chronic low back pain, no current neurologic signs or symptoms, no previous spinal surgery, no corticosteroid treatment within the last two weeks, and who are not pregnant will be recruited for this study. Patients will sign an informed consent, complete all initial paperwork. Surface electromyography will be used to quantify the activity level of the Gmax and lumbar paraspinals (LP). The MVIC will be estimated for each muscle group and the patient will perform a series of 4 randomized exercises, 5 repetitions each; Clams with Resistance, Standing Hip Abduction with Resistance, Sidelying Hip Abduction, and a forward bend. After each exercise the patient will rate "How hard they are working" on the RISE scale. Following the initial test, Cramer® Sports Motion Tape will be applied to the gluteal and low back area. After the tape is applied, the EMG exercise protocol will be repeated. The tape will be left on until the patient returns for their next appointment, within 24 to 48 hours, where they will have a delayed post-test. Patients will rate their pain, surface electrodes will be applied to the previous testing sites, and MVIC will be retested for each muscle group. The patient will perform the same protocol that was performed in the initial testing session. The EMG signals will be smoothed, rectified and analyzed using a root-mean-square algorithm. The investigators will use visual onset and offset of the EMG signal amplitude to select the middle 3 trials. Average activation and peak activation will be determined and compared to the MVIC for each muscle group, and expressed as a %MVIC. This will allow %MVIC to be compared and rank order among groups and muscles.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • must be recruited within the first 2 to 3 therapy visits
  • have a diagnosis of chronic mechanical low back pain

排除标准

  • no current neurologic signs or symptoms
  • no previous spinal surgery
  • no corticosteroid treatment within the last two weeks
  • may not be pregnant

结局指标

主要结局

Percent of Maximal Voluntary Isometric Contraction (%MVIC)

时间窗: % Maximal Voluntary Isometric Contracion (%MVIC)

3 muscles during 4 exercises (ClamsR, Sidelying, StandingAB, ForwardBend) at 3 time points (Baseline\[T1\], Immediate post\[T2\], 24hrs\[T3\]), were analyzed in 20 subjects, totaling 720 data points. Maximal voluntary isometric contraction(MVIC) was assessed using the standard manual muscle testing positions. For each subject, the EMG signals of the muscles during the exercises were smoothed, rectified and analyzed using a root-mean-square algorithm and the greatest activation of each muscle was used. After the peak activation(PA) for each muscle was determined, it was compared to the MVIC of the reference exercise for the respective muscle group, and expressed as a percent of MVIC (%MVIC). In some cases the %MVIC is greater than 100% because the MVIC was assessed during a manual muscle test position. During an exercise some muscles generated greater PA and therefore when calculated the %MVIC was greater than 100%. Due to the amount of data, we have provided the Gmax %MVIC results.

次要结局

  • Perceived Exertion(Perceived Exertion)

研究者

发起方
Sport and Spine Rehab Clinical Research Foundation
申办方类型
Other
责任方
Sponsor

研究点 (2)

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