Validation of Algometry for Use in the Human Foot

Sponsor
Dundee Podiatry Clinic (Other)
Overall Status
Unknown status
CT.gov ID
NCT01940289
Collaborator
(none)
544
1
2
5.9
91.5

Study Details

Study Description

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
  • Device: Algometric meter readings for perception of pain
N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Jan 1, 2014
Anticipated Primary Completion Date :
Jul 1, 2014
Anticipated Study Completion Date :
Jul 1, 2014

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Algometric pressure threshold scores [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 [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dundee Podiatry Clinic Dundee Angus United Kingdom DD5 1HY

    Sponsors and Collaborators

    • Dundee Podiatry Clinic

    Investigators

    • Principal Investigator: David G Cashley, BSc(Hons)Pod, Dundee Podiatry Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dundee Podiatry Clinic
    ClinicalTrials.gov Identifier:
    NCT01940289
    Other Study ID Numbers:
    • PTM001
    First Posted:
    Sep 12, 2013
    Last Update Posted:
    Sep 18, 2013
    Last Verified:
    Sep 1, 2013
    Keywords provided by Dundee Podiatry Clinic

    Study Results

    No Results Posted as of Sep 18, 2013