Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000239066
Ethics application status
Approved
Date submitted
18/03/2010
Date registered
23/03/2010
Date last updated
11/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Ultrasound guided corticosteroid injection for plantar fasciitis: a randomised controlled trial
Scientific title
Ultrasound guided corticosteroid injection for treatment of pain associated with plantar fasciitis: a randomised controlled trial
Secondary ID [1] 1532 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plantar fasciitis 256991 0
Condition category
Condition code
Musculoskeletal 257144 257144 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ultrasound guided injection of the plantar fascia with 1mL of 4mg/mL dexamethasone sodium phosphate
Intervention code [1] 256164 0
Treatment: Drugs
Comparator / control treatment
Ultrasound guided injection of the plantar fascia with 1mL normal (isotonic) saline
Control group
Placebo

Outcomes
Primary outcome [1] 258037 0
Pain measured on a visual analogue scale
Timepoint [1] 258037 0
Baseline, then 1, 2 and 3 months post randomisation
Primary outcome [2] 258038 0
Plantar fascia thickness measured by diagnostic ultrasound
Timepoint [2] 258038 0
Baseline, then 1, 2 and 3 months post randomisation
Secondary outcome [1] 263613 0
Function measured by the Foot Health Status Questionnaire
Timepoint [1] 263613 0
Baseline, then 1, 2 and 3 months post randomisation
Secondary outcome [2] 263614 0
Daily use of oral analgesic medication, self-reported in a diary
Timepoint [2] 263614 0
Baseline, then 1, 2 and 3 months post randomisation
Secondary outcome [3] 263615 0
First step pain measured on a visual analogue scale
Timepoint [3] 263615 0
Baseline, then 1, 2 and 3 months post randomisation

Eligibility
Key inclusion criteria
History of pain beneath the heel for minimum 8 weeks

Minimum heel pain magnitude of 20mm on visual analogue scale

Sensitivity to palpation of medial calcaneal tubercle and/or the proximal plantar fascia

Minimum plantar fascia thickness value of 4.0mm as measured by ultrasound
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Corticosteroid injection for plantar fasciitis within previous 6 months. Known hypersensitivity to lignocaine or dexamethasone. Current skin or soft tissue infection near injection site. Current pregnancy. Systemic inflammatory disease. Diabetes Mellitus. Previous local surgery or trauma. Commencement of any treatment for plantar fasciitis within four weeks prior to enrolment

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed in a password-protected computer file.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Treatment allocation will be performed according to a computer-generated random allocation sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
17/05/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256668 0
Charities/Societies/Foundations
Name [1] 256668 0
Australasian Podiatry Council
Country [1] 256668 0
Australia
Primary sponsor type
University
Name
Department of Podiatry, La Trobe University
Address
Bundoora, Victoria, 3086
Country
Australia
Secondary sponsor category [1] 255956 0
University
Name [1] 255956 0
Musculoskeletal Research Centre, La Trobe University
Address [1] 255956 0
Bundoora, Victoria, 3086
Country [1] 255956 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258695 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 258695 0
Ethics committee country [1] 258695 0
Australia
Date submitted for ethics approval [1] 258695 0
Approval date [1] 258695 0
16/02/2010
Ethics approval number [1] 258695 0
09062

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30956 0
Address 30956 0
Country 30956 0
Phone 30956 0
Fax 30956 0
Email 30956 0
Contact person for public queries
Name 14203 0
Andrew McMillan
Address 14203 0
Department of Podiatry
La Trobe University
Bundoora, Victoria, 3086
Country 14203 0
Australia
Phone 14203 0
+61 3 9479 5785
Fax 14203 0
Email 14203 0
[email protected]
Contact person for scientific queries
Name 5131 0
Andrew McMillan
Address 5131 0
Department of Podiatry
La Trobe University
Bundoora, Victoria, 3086
Country 5131 0
Australia
Phone 5131 0
+61 3 9479 5785
Fax 5131 0
Email 5131 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.