Normative Algometric PressuresNCT01940289
Validation of Algometry for Use in the Human Foot
A study testing Algometric meter readings for perception of pain in people with Normative Algometric Pressures and Foot Pain, run by Dundee Podiatry Clinic at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Normative Algometric Pressures, Foot Pain
- What is being tested?
- Algometric meter readings for perception of pain
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 544 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2014to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients attending a local podiatric clinic for routine nail care or complaining of forefoot pain
Who cannot join
- forefoot surgery
- Diabetes
- Rheumatoid Arthritis
- Osteopenia
- All subjects with a diagnosed neurological condition
- Chronic pain at any body location
- Fibromyalgia
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Dundee Podiatry Clinic
Dundee, Angus, DD5 1HY
David G Cashley, BSc(Hons)Pod, 01382 779399, dgcashley@googlemail.com
David G Cashley, BSc(Hons)Pod
About this study
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
- Being tested
- Algometric meter readings for perception of pain
- Keywords
- algometry, pain, VAS
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Algometric meter readings for perception of painDevice
Also called pressure threshold pain readings, pressure/pain readings
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Algometric meter readings for perception of pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Algometric pressure threshold scores
Using algometric meter readings compared to Visual analogue pain scale readings to establish whether the two measures correlate
Measured: 6 months
Secondary outcomes (1)
visual analogue pain scale scores
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2013 (estimated)
- Study startJan 2014
- Primary completionJul 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normative Algometric PressuresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 544 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dundee Podiatry Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David G Cashley, BSc(Hons)Pod, Principal investigator, Dundee Podiatry Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01940289
- Sponsor's protocol ID
- PTM001
- Status last verified
- Sep 2013
- First submitted
- 9 Sep 2013
- Last updated
- 18 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Algometry for Use in the Human Foot
- ClinicalTrials.gov ID
- NCT01940289
- Acronym / sponsor ID
- PTM001
- Conditions
- Normative Algometric Pressures, Foot Pain
- Keywords
- algometry, pain, VAS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 544 participants (estimated)
- Lead sponsor
- Dundee Podiatry ClinicUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 12 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| asymptomatic subjects attending podiatry clinic for nail care | Active comparator | Device: Algometric meter readings for perception of painAlgometric 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 |
| forefoot pain | Active comparator | Device: Algometric meter readings for perception of painAlgometric meter readings for perception of pain forefoot pain severity measured by both VAS and algometric pressure meter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients attending a local podiatric clinic for routine nail care or complaining of forefoot pain
Key exclusion criteria (7 listed)
- forefoot surgery
- Diabetes
- Rheumatoid Arthritis
- Osteopenia
- All subjects with a diagnosed neurological condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Algometric meter readings for perception of painAlso: pressure threshold pain readings, pressure/pain readings | Device | asymptomatic subjects attending podiatry clinic for nail care, forefoot pain |
Primary outcome
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
1 secondary outcome
visual analogue pain scale scores
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David G Cashley, BSc(Hons)Pod principal investigator
Dundee Podiatry Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Algometric meter readings for perception of pain in people with Normative Algometric Pressures and Foot Pain, run by Dundee Podiatry Clinic at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Algometric pressure threshold scores (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2013.