Oldpain2go®: an Exploratory (Pre-Feasibility) Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- A 100mm pain intensity Visual Analogue Scale (VAS) for low back pain
研究概览
简要总结
Research question: Is there any evidence to suggest that the oldpain2go® intervention merits scientific investigation?
详细描述
Aims:
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To collect data to:
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give an indication of the potential effect size, of any effects, from the oldpain2go® intervention, in people with persistent low back pain.
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to explore the eligibility criteria, recruitment methods and materials proposed here, for potential use in a future Feasibility study, of the oldpain2go® intervention.
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To compare demographic characteristics, medical history and outcome measure data of:
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people for whom Oldpain2go® is indicated (at the Oldpain2go® screening session), with those for whom it is not,
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people for whom the Oldpain2go® intervention works, after one treatment, with those for whom it does not, and
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people for whom the Oldpain2go® intervention works, after one, or two, treatments, with those for whom it does not work after two treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Currently suffering from persistent, non-specific, low back pain
- •Aged over 18 years
- •For whom Oldpain2go® is indicated as a treatment option after the standard clinical screening process for the Oldpain2go® treatment
排除标准
- •Any Red Flags,
- •Any causative (or potentially causative) structural abnormality, or pathology detected or suspected
- •Any concurrent pathology, or condition that would limit options for Physiotherapy treatment,
- •Lack of (or any reason to doubt presence of) Mental Capacity to give Informed Consent
结局指标
主要结局
A 100mm pain intensity Visual Analogue Scale (VAS) for low back pain
时间窗: Change measures at three points, baseline, 1 week and 2 weeks from baseline
A self reported pain level scale
次要结局
- The Roland Morris Disability Questionnaire (RMDQ)(Change measures at three points, baseline, 1 week and 2 weeks from baseline)
研究者
Alasdair MacSween
Principal Lecturer in Research Governance
Teesside University