Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612000279820
Ethics application status
Not yet submitted
Date submitted
1/03/2012
Date registered
9/03/2012
Date last updated
9/03/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Validation of a Clinical Questionnaire for the Diagnosis of Plantar Fasciitis
Scientific title
Validation of a clinical questionnaire for the diagnosis of Plantar Fasciitis in patient with a painful condition affecting the foot and ankle.
Secondary ID [1] 280063 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plantar Fasciitis 285973 0
Condition category
Condition code
Public Health 286161 286161 0 0
Health service research
Musculoskeletal 286175 286175 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All consecutive patients referred to an orthopaedic foot and ankle private practice will be invited to participate in this study. Upon referral to the foot and ankle clinic by their physician, a package will be mailed out to each patient containing the questionnaire and a letter describing the project. A consent form for participation in the study will also be included in the pack. If the patient agrees to participate, he or she will complete the questionnaire at home. When each participant arrives to the clinic at their booked appointment, the same questionnaire would then be administered to the patient for completion in the waiting room. The patients will then undergo the usual consultation by a Fellowship trained foot and ankle surgeon and a diagnosis for their complaint will be determined. Patient height and weight will also be measured at the initial clinical visit. The self-administered questionnaire has been devised to reflect a formalized history and physical examination, particularly relating to the diagnosis of plantar fasciitis. It contains six questions characterizing the patient’s symptoms and one question to identify the location of maximal pain. Each question has been selected to reflect pertinent positive findings, both during the history and physical examination for the diagnosis of plantar fasciitis. it is estimated it will take the patient 15 minutes to complete the questionnaire.
Intervention code [1] 284386 0
Diagnosis / Prognosis
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286633 0
The aim of this study is to develop a validated, scored, self-administered patient questionnaire that can reproducibly and reliably identify patients with a diagnosis of plantar fasciitis in a population presenting with foot and ankle complaints.
Timepoint [1] 286633 0
the outcome will be assessed immediately after information delivery
Secondary outcome [1] 296332 0
Nil
Timepoint [1] 296332 0
Nil

Eligibility
Key inclusion criteria
Primary language is English, patient must be able to read and write in English, patient must have a painful condition affecting the foot and ankle.
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to read or write in English

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284816 0
Charities/Societies/Foundations
Name [1] 284816 0
Epworth Foundation - Foot and Ankle Research Fund
Country [1] 284816 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Epworth Foundation - Foot and Ankle Research Fund
Address
32 Erin Street
Richmond
Vic 3121
Australia
Country
Australia
Secondary sponsor category [1] 283696 0
None
Name [1] 283696 0
Address [1] 283696 0
Country [1] 283696 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286806 0
Epworth Healthcare
Ethics committee address [1] 286806 0
32 Erin Street
Richmond
Vic 3121
Ethics committee country [1] 286806 0
Australia
Date submitted for ethics approval [1] 286806 0
04/04/2012
Approval date [1] 286806 0
Ethics approval number [1] 286806 0
TBA

Summary
Brief summary
The null hypothesis is that a scored, formalized questionnaire reflecting a focused history and clinical examination for a patient presenting with heel pain will not reliably and reproducibly identify patients with a diagnosis of plantar fasciitis in a population of patients presenting with foot and ankle complaints.
Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 33858 0
Address 33858 0
Country 33858 0
Phone 33858 0
Fax 33858 0
Email 33858 0
Contact person for public queries
Name 17105 0
Kate Claxton
Address 17105 0
Epworth Centre
Suite 6.3, Level 6
32 Erin Street
Richmond
Vic 3121
Country 17105 0
Australia
Phone 17105 0
+61 3 9428 9944
Fax 17105 0
+61 3 9428 3444
Email 17105 0
[email protected]
Contact person for scientific queries
Name 8033 0
Kate Claxton
Address 8033 0
Epworth Centre
Suite 6.3, Level 6
32 Erin Street
Richmond
Vic 3121
Country 8033 0
Australia
Phone 8033 0
+61 3 9428 9944
Fax 8033 0
+61 3 9428 3444
Email 8033 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.