Validation of Algometry for Use in the Human Foot | NCT01940289

Studies
Validation of Algometry for Use in the Human Foot

NCT01940289

Sponsor

Dundee Podiatry Clinic

Status

Unknown status

Last Update Posted

Sep 18, 2013Estimated

Enrollment

544Estimated

Phase

Not Applicable

Conditions

Normative Algometric Pressures
Foot Pain

Interventions

Algometric meter readings for perception of pain

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Jul 2014Estimated

Completion Date

Jul 2014Estimated

First Submitted Date

Sep 9, 2013

First Submission Date that Met QC Criteria

Sep 9, 2013

First Posted Date

Sep 12, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2013

Last Update Posted Date

Sep 18, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

544Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Algometric meter readings for perception of pain	Device		asymptomatic subjects attending podiatry clinic for nail care forefoot pain

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
visual analogue pain scale scores		6 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David G Cashley, BSc(Hons)Pod	Dundee Podiatry Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dundee Podiatry Clinic		Dundee	Angus	DD5 1HY	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

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