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临床试验/NCT01940289
NCT01940289Unknown不适用

Validation of Algometry for Use in the Human Foot

Dundee Podiatry Clinic2 个研究点 分布在 1 个国家目标入组 544 人开始时间: 2014年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
544
试验地点
2
主要终点
Algometric pressure threshold scores

研究概览

简要总结

The primary aim is to examine whether there is a consistent range of pressure threshold values for the asymptomatic foot.Previous studies established the inter/intra-clinician reliability of pressure threshold measuring and have established a normative range of values within the trunk and upper body. Since the establishment of these values, pressure threshold testing has been used extensively in the head, neck, shoulders and spine as a clinical tool and a research aid. There has been little work using it in the lower limb and there are no guideline measurements for the clinician. By establishing a range of values for the foot,this study will enable the clinician to employ pressure threshold measuring as a clinical tool to easily and accurately identify areas of dysfunction and to objectively measure the effectiveness of treatment. It will allow the clinician to establish a degree of improvement or deterioration as it occurs in a patient's condition.

Secondary aims are to examine whether there is a correlation between visual analogue pain scale (VAS) scores and algometric pressure threshold scores for subjects with forefoot pain. This will help validate the tool for use in the foot. Since VAS is well documented and validated, this study will examine whether there is a correlation between VAS and algometry and whether there are gender or age differences in the range of measurements obtained. These areas have been addressed in previous studies but results have been contradictory and inconclusive and none of the previous studies focused on the foot.

An asymptomatic group of 384 subjects & symptomatic group of 160 subjects shall be selected from those attending a podiatric clinic for routine foot care who meet the inclusion criteria . Outcome me will be algometric pressure threshold testing, visual analogue pain scales and foot function index questionnaires.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients attending a local podiatric clinic for routine nail care or complaining of forefoot pain

排除标准

  • forefoot surgery
  • Rheumatoid Arthritis
  • Osteopenia
  • All subjects with a diagnosed neurological condition
  • Chronic pain at any body location
  • Fibromyalgia

结局指标

主要结局

Algometric pressure threshold scores

时间窗: 6 months

Using algometric meter readings compared to Visual analogue pain scale readings to establish whether the two measures correlate

次要结局

  • visual analogue pain scale scores(6 months)

研究者

发起方
Dundee Podiatry Clinic
申办方类型
Other
责任方
Sponsor

研究点 (2)

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