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Validation of Algometry for Use in the Human Foot

Validation of Algometry for Use in the Human Foot

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01940289
Enrollment
544
Registered
2013-09-12
Start date
2014-01-31
Completion date
2014-07-31
Last updated
2013-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Foot Pain, Normative Algometric Pressures

Keywords

algometry, pain, VAS

Brief summary

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.

Interventions

DEVICEAlgometric meter readings for perception of pain

Sponsors

Dundee Podiatry Clinic
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Algometric pressure threshold scores6 monthsUsing algometric meter readings compared to Visual analogue pain scale readings to establish whether the two measures correlate

Secondary

MeasureTime frame
visual analogue pain scale scores6 months

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026