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Trial record 2 of 8 for:    Podiatry | First posted from 01/01/2013 to 11/22/2013

Validation of Algometry for Use in the Human Foot

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01940289
Recruitment Status : Unknown
Verified September 2013 by Dundee Podiatry Clinic.
Recruitment status was:  Not yet recruiting
First Posted : September 12, 2013
Last Update Posted : September 18, 2013
Sponsor:
Information provided by (Responsible Party):
Dundee Podiatry Clinic

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.


Condition or disease Intervention/treatment Phase
Normative Algometric Pressures Foot Pain Device: Algometric meter readings for perception of pain Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 544 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Basic Science
Official Title: Validation of Algometry for Use in the Human Foot
Study Start Date : January 2014
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

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




Primary Outcome Measures :
  1. Algometric pressure threshold scores [ Time Frame: 6 months ]
    Using algometric meter readings compared to Visual analogue pain scale readings to establish whether the two measures correlate


Secondary Outcome Measures :
  1. visual analogue pain scale scores [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01940289


Locations
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United Kingdom
Dundee Podiatry Clinic
Dundee, Angus, United Kingdom, DD5 1HY
Contact: David G Cashley, BSc(Hons)Pod    01382 779399    dgcashley@googlemail.com   
Principal Investigator: David G Cashley, BSc(Hons)Pod         
Sponsors and Collaborators
Dundee Podiatry Clinic
Investigators
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Principal Investigator: David G Cashley, BSc(Hons)Pod Dundee Podiatry Clinic
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Responsible Party: Dundee Podiatry Clinic
ClinicalTrials.gov Identifier: NCT01940289    
Other Study ID Numbers: PTM001
First Posted: September 12, 2013    Key Record Dates
Last Update Posted: September 18, 2013
Last Verified: September 2013
Keywords provided by Dundee Podiatry Clinic:
algometry
pain
VAS