Validation of Algometry for Use in the Human Foot

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.

Study Overview

• Status: Unknown
• Conditions: Foot Pain; Normative Algometric Pressures
• Intervention / Treatment: Device: Algometric meter readings for perception of pain

• Study Type: Interventional
• Enrollment (Anticipated): 544
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Angus
    • Dundee, Angus, United Kingdom, DD5 1HY
      • Dundee Podiatry Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Device: Algometric meter readings for perception of pain; Other Names: pressure threshold pain readings; pressure/pain readings
Active Comparator: forefoot pain; Algometric meter readings for perception of pain forefoot pain severity measured by both VAS and algometric pressure meter	Device: Algometric meter readings for perception of pain; Other Names: pressure threshold pain readings; pressure/pain readings

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Algometric pressure threshold scores	Using algometric meter readings compared to Visual analogue pain scale readings to establish whether the two measures correlate	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
visual analogue pain scale scores	6 months

Collaborators and Investigators

• Sponsor: Dundee Podiatry Clinic
• Investigators: Principal Investigator: David G Cashley, BSc(Hons)Pod, Dundee Podiatry Clinic

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): July 1, 2014
• Study Completion (Anticipated): July 1, 2014

Study Registration Dates

• First Submitted: September 9, 2013
• First Submitted That Met QC Criteria: September 9, 2013
• First Posted (Estimate): September 12, 2013

Study Record Updates

• Last Update Posted (Estimate): September 18, 2013
• Last Update Submitted That Met QC Criteria: September 17, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: pain; VAS; algometry
• Other Study ID Numbers: PTM001