Validation of Algometry for Use in the Human Foot

Dundee Podiatry Clinic

Status: Unknown

Conditions: Normative Algometric Pressures; Foot Pain

Treatments: Device: Algometric meter readings for perception of pain

Study type: Interventional

Funder types: Other

Identifiers

NCT01940289

PTM001

Details and patient eligibility

About

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.

Enrollment: 544 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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544 participants in 2 patient groups

asymptomatic subjects attending podiatry clinic for nail care

Active Comparator group

Description:

Algometric meter readings for perception of pain These subjects will have an algometric pressure threshold meter reading taken during their routine treatment visit to establish Algometric meter readings for perception of pain

Treatment:

Device: Algometric meter readings for perception of pain

forefoot pain

Active Comparator group

Description:

Algometric meter readings for perception of pain forefoot pain severity measured by both VAS and algometric pressure meter

Treatment:

Device: Algometric meter readings for perception of pain