Validation of Algometry for Use in the Human Foot

NCT01940289 | Unknown DMC

• 1 other identifier: PTM001
• Study Type: interventional
• Target: 544
• Locations: 1 country
• Sites: 1

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.

Conditions

Normative Algometric Pressures; Foot Pain

Keywords

algometry; pain; VAS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• visual analogue pain scale scores

  6 months

Study Arms (2)

asymptomatic subjects attending podiatry clinic for nail care

ACTIVE COMPARATOR

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

forefoot pain

ACTIVE COMPARATOR

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

Interventions

Algometric meter readings for perception of pain DEVICE

Also known as: pressure threshold pain readings, pressure/pain readings

asymptomatic subjects attending podiatry clinic for nail care; forefoot pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dundee Podiatry Clinic: lead

Study Sites (1)

Dundee Podiatry Clinic

Dundee, Angus, DD5 1HY, United Kingdom

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David G Cashley, BSc(Hons)Pod

  Dundee Podiatry Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2013
• First Posted: September 12, 2013
• Study Start: January 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: September 18, 2013

Record last verified: 2013-09

Locations

GB (1)