Clinical trial NCT01940289: Validation of Algometry for Use in the Human Foot
Official title: Validation of Algometry for Use in the Human Foot
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Normative Algometric Pressures
Foot Pain
Keywords: algometry
pain
VAS
Lead sponsor: Dundee Podiatry Clinic
Sponsor class: OTHER
First posted: 2013-09-12
Enrollment: 544
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Algometric pressure threshold scores
timeFrame: 6 months
Secondary outcomes:
measure: visual analogue pain scale scores
timeFrame: 6 months
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: Dundee Podiatry Clinic
state: Angus
Study officials:
affiliation: Dundee Podiatry Clinic
name: David G Cashley, BSc(Hons)Pod
role: PRINCIPAL_INVESTIGATOR
References: