A Prospective Open Label Pilot Study Investigating the Impact of ThermaCare on Flexibility, Muscle Relaxation & Low Back Pain in Two Different Populations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- dorsaVi Ltd
- 入组人数
- 40
- 试验地点
- 6
- 主要终点
- Change in Movement Data Over Time
研究概览
简要总结
The objective of this Investigator Initiated study is to evaluate the effectiveness of ThermaCare HeatWraps in improving flexibility and low back muscle relaxation, and in participants experiencing pain, reducing pain during movement. This study is an intervention trial on two discrete subject samples; (1) people with recent back pain, and (2) people who regularly play sport. ViMove wearable sensors provide precise objective measurements of low back muscle activity and movement in real time and can capture a patient's reporting of pain during movement. Outcomes will be assessed through standard ViMove protocols in conjunction with multiple validated measures of pain, perception of change, and function.
详细描述
This investigator-initiated study will utilize a prospective open-label study design to evaluate the effectiveness of ThermaCare HeatWraps in improving flexibility and low back muscle relaxation, and in participants experiencing pain, reducing pain during movement. Two discrete subject samples will be enrolled; (1) people with recent back pain, and (2) people who regularly play sport. Both samples will be enrolled using respective criteria.
Following enrollment, both subject groups will have a "start interview" on their allocated baseline assessment day (Day 1). This will include fitting of the ViMove movement and EMG sensors, as well as a live "pain on movement" assessment. This session will take approximately 20-30 minutes. Whilst wearing the ViMove sensors, subjects will then leave the clinic and conduct normal daily activities for a pre-determined monitoring period. No ThermaCare HeatWraps are worn on Day 1. This allows a baseline assessment and allows any placebo effects from the sensors to be discounted. At the end of the monitoring session, subjects will return to the clinic to have an "end-of-day" interview. Clinicians will administer the Oswestry Disability Index (ODI), the Visual Analogue Scale for Pain (VAS Pain), and the Patient Global Impression of Change scale (PGIC). ViMove movement sensors will then be removed, and the subject will be reimbursed for that day.
The intervention day (Day 2) will have the same procedure as Day 1 (baseline), with the only difference being the additional application of ThermaCare HeatWraps during the "start interview". Subjects will continue to wear the HeatWrap and ViMove sensors during the 8-hour daily activity monitoring period, with the wrap and sensors being removed during the end-of-day interview. The subject will then be reimbursed for Day 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This study is open label, meaning that no masking occurs
入排标准
- 年龄范围
- 21 Years 至 54 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Low Back Pain Group
Low Back Pain (LBP) group will be assessed on two consecutive days. The first day will have no ThermaCare intervention applied, and is for a Baseline assessment of flexibility, muscle relaxation and low back pain.
The second day will have the ThermaCare Low Back Heat Wrap intervention applied, and will have the same assessments as the Baseline day.
干预措施: ThermaCare Low Back Heat Wrap (Device)
Active in Sport Group
Sport group will be assessed on two consecutive days. The first day will have no ThermaCare intervention applied, and is for a baseline assessment of flexibility, muscle relaxation and low back pain.
The second day will have the ThermaCare Low Back Heat Wrap intervention applied, and will have the same assessments as the Baseline day.
干预措施: ThermaCare Low Back Heat Wrap (Device)
结局指标
主要结局
Change in Movement Data Over Time
时间窗: Change from Baseline movement data after 1 consecutive day.
Collection of movement data from all participants. The results listed here depict the average change in Trunk Range of Motion (ROM) between day 1 and day 2 PM sessions
Change in Erector Spinae Muscle Activity Over Time
时间窗: Change from Baseline Erector spinae muscle activity data after 1 consecutive day.
Collection of erector spinae muscle activity data from all participants. The results provided depict the mean muscle-activity difference between the day 1 and day 2 PM sessions. Surface Electromyography (sEMG) sensors are adhered utilizing a height-specific sensor placement template. Placement is parallel with the L3 vertebrae. Evaluated in the form of the flexion-relaxation response. When performing a forward flexion movement, muscle activation occurs at the commencement of the movement (when bending down;concentric), as well as during the return to the upright position (eccentric). At maximum flexion, minimal muscle activation is expected (i.e. muscle relaxation). However, in subjects with Low-back pain, muscle relaxation is often absent. As such, the following formula is used to evaluate the flexion-relaxation response. Sum of sEMG activity at maximum flexion divided by the summed sEMG activity of both concentric and eccentric muscle activation.
次要结局
- Impression of Change From Subjects Post Intervention and/or Assessment Period Using the Patient Global Impression of Change Scale (PGIC).(Change from Baseline after 1 consecutive day.)
- Observation of Self-reported Changes in Functional Status Pre- and Post- ThermaCare Application as Measured by the Roland Morris Disability Questionnaire (RMDQ) if Subjects Scored >3 on the NRS(Change from Baseline after 1 consecutive day.)
- In Group 1 (LBP Patients), a Change in Maximum Pain During Movement Score, for Any One Plane of Movement.(Change from Baseline after 1 consecutive day.)
- A Change in Muscle Activity From Baseline in Subjects Where Abnormal EMG Activity During Baseline is Detected.(Change from Baseline after 1 consecutive day.)
- A Change Over Time in Range of Motion in Any One Plane of Movement Compared to Pre-intervention Range of Motion.(Change from Baseline after 1 consecutive day.)
- Change in Pain From Baseline(Change from Baseline after 1 consecutive day.)
- Observation of Self-reported Changes in Functional Status Pre- and Post- ThermaCare Application as Measured by the Oswestry Disability Index (ODI) if Subjects Scored >3 on the NRS(Change from Baseline after 1 consecutive day.)