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Validation of Algometry for Use in the Human Foot

NCT ID: NCT01940289

Last Updated: 2013-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

544 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Normative Algometric Pressures Foot Pain

Keywords

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algometry pain VAS

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

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asymptomatic subjects attending podiatry clinic for nail care

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

Group Type ACTIVE_COMPARATOR

Algometric meter readings for perception of pain

Intervention Type DEVICE

forefoot pain

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

Group Type ACTIVE_COMPARATOR

Algometric meter readings for perception of pain

Intervention Type DEVICE

Interventions

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Algometric meter readings for perception of pain

Intervention Type DEVICE

Other Intervention Names

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pressure threshold pain readings pressure/pain readings

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dundee Podiatry Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David G Cashley, BSc(Hons)Pod

Role: PRINCIPAL_INVESTIGATOR

Dundee Podiatry Clinic

Locations

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Dundee Podiatry Clinic

Dundee, Angus, United Kingdom

Site Status

Countries

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United Kingdom

Facility Contacts

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David G Cashley, BSc(Hons)Pod

Role: primary

Other Identifiers

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PTM001

Identifier Type: -

Identifier Source: org_study_id