A Multicentre, Cluster Randomised, Placebo-controlled, Open-label Pilot Study of Back Strain Monitor (BSM) With Feedback Compared With the BSM Without Feedback in Subjects With Moderate Lower Back Pain.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 18
- 主要终点
- Quadruple Visual Analogue Scale (QVAS)
研究概览
简要总结
A postural bio-feedback device worn by subjects for 4-10 hours a day for 6 days spread across 6 weeks for the sub acute low back pain group and for 8 days spread across 10 weeks for the chronic group. The device records movement and muscle activity data relating to the lower back. Bio-feedback is delivered to the subject as an audible tone, visual cue or vibration and aims to prompt the subject to alter their posture or position in line with recommendations given by the treating practitioner. Four small sensors are adhered to the lower back and send data wirelessly to a data logger carried in the pocket by the subject (the size of a small mobile phone).
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
- 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
- 否
入选标准
- •Subject provides informed consent
- •Age between 18 and 65 years of age
- •At least moderate intensity low back pain (LBP) and/or back related leg pain, as defined by a QVAS score > 3 (Carragee, Spine 2000).
- •Initial QVAS score of > 3 out of 10
- •Subjects must be assessed by the practitioner as Sub Acute (3 to 12 weeks post onset of low back pain (LBP) or Chronic (> 12 weeks post onset of low back pain (LBP).
排除标准
- •Lower back surgery within previous twelve (12) months.
- •Females who are pregnant.
- •Subjects with a severe hearing impairment.
- •Evidence of non mechanical contributing cause for lower back pain e.g. neoplasm, infection, fracture, inflammatory disorder.
- •Preceding chronic neurological changes (Sub Acute group only).
- •Implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator)
- •Nerve block, spinal injection or anesthetic procedure for the treatment of lower back pain within 12 months of the study.
- •Significant medical abnormalities or conditions that in the opinion of the Practitioner would interfere either with the ability to complete the study or the evaluation of the investigational device's safety and efficacy.
- •Recent history of a significant medical-surgical intervention that in the judgment of the Practitioner would interfere either with the ability to complete the study or the evaluation of the investigative device's safety and efficacy.
- •Known allergic skin reaction to tapes and plasters.
- •Subject who is currently enrolled in an investigational drug or device study.
研究组 & 干预措施
Control
The BSM device without feed-back
干预措施: BSM device with no bio-feedback (Device)
Intervention
BSM device with bio-feedback
干预措施: BSM device with bio-feedback (Device)
结局指标
主要结局
Quadruple Visual Analogue Scale (QVAS)
时间窗: over 12 months
Pain Scale
Roland Morris Disability Questionaire (RMDQ-23)
时间窗: over 12 months
Functional Outcome measure
Patient Specific Functional Scale (PSFS)
时间窗: over 12 months
Functional Outcome Measure
次要结局
- The change over time from baseline in the range of movement, recorded by the device. Measured in degrees of movement in the three anatomical planes.(over 12 months)