Validation of Algometry for Use in the Human Foot

Foot Pain Clinical Trial

Official title:

Validation of Algometry for Use in the Human Foot

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01940289
• Other study ID #: PTM001
• Status: Not yet recruiting
• Phase: N/A
• First received: September 9, 2013
• Last updated: September 17, 2013
• Start date: January 2014
• Est. completion date: July 2014

Study information

• Verified date: September 2013
• Source: Dundee Podiatry Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 544
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Foot Pain
• Normative Algometric Pressures

Intervention

Device:
• Algometric meter readings for perception of pain

Locations

Country	Name	City	State
United Kingdom	Dundee Podiatry Clinic	Dundee	Angus

Sponsors (1)

Lead Sponsor	Collaborator
Dundee Podiatry Clinic

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Algometric pressure threshold scores	Using algometric meter readings compared to Visual analogue pain scale readings to establish whether the two measures correlate	6 months	No
Secondary	visual analogue pain scale scores		6 months	No