Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000068662
Ethics application status
Approved
Date submitted
2/08/2005
Date registered
2/08/2005
Date last updated
2/08/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of calf muscle stretching for plantar fasciitis: a randomised trial
Scientific title
Effectiveness of calf muscle stretching for the reduction of symptoms of plantar fasciitis: a randomised trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plantar fasciitis 140 0
Condition category
Condition code
Inflammatory and Immune System 160 160 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group: Calf muscle stretches using wooden wedge (five minutes daily for two weeks) and placebo ultrasound (one initial session).
Intervention code [1] 99 0
None
Comparator / control treatment
Placebo group: placebo ultrasound only (one initial session).
Control group
Placebo

Outcomes
Primary outcome [1] 199 0
1) Visual Analogue Scale - first-step pain.
Timepoint [1] 199 0
Measured at baseline and follow-up (two weeks later).
Primary outcome [2] 200 0
2) Foot Health Status Questionnaire - foot pain, foot function, general foot health.
Timepoint [2] 200 0
Measured at baseline and follow-up (two weeks later).
Secondary outcome [1] 456 0
1) Foot Posture Index
Timepoint [1] 456 0
Measured at baseline and follow-up (two weeks later).
Secondary outcome [2] 457 0
2) Ankle range of motion
Timepoint [2] 457 0
Measured at baseline and follow-up (two weeks later).

Eligibility
Key inclusion criteria
Plantar fasciitis symptoms (localised pain at heel; worse on first rising; reduces with initial activity; pain increases with increasing activity); symptoms present for four weeks or more; able to complete outcomes; informed consent.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Orthopaedic, metabolic or endocrine disorders that may affect the plantar fascia; cortisone injection in past three months.

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)
Sealed opaque envelopes. Before opening participant details were written on envelope and video taped. Aluminium foil inside envelope to render envelope impermeable to intense light.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated sequence using Microsoft Excel with a single block.
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
Completed
Date of first participant enrolment
Anticipated
6/04/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
92
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 213 0
University
Name [1] 213 0
University of Western Sydney
Country [1] 213 0
Australia
Primary sponsor type
University
Name
University of Western Sydney
Address
Country
Australia
Secondary sponsor category [1] 160 0
None
Name [1] 160 0
None
Address [1] 160 0
Country [1] 160 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 978 0
University of Western Sydney Human Ethics Committee
Ethics committee address [1] 978 0
Ethics committee country [1] 978 0
Australia
Date submitted for ethics approval [1] 978 0
Approval date [1] 978 0
Ethics approval number [1] 978 0

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

Contacts
Principal investigator
Name 35937 0
Address 35937 0
Country 35937 0
Phone 35937 0
Fax 35937 0
Email 35937 0
Contact person for public queries
Name 9288 0
Joel Radford
Address 9288 0
School of Exercise and Health Sciences
University of Western Sydney
Campbelltown Campus
Building 24
Locked Bag 1797
Penrith South DC NSW 1797
Country 9288 0
Australia
Phone 9288 0
+61 2 46203790
Fax 9288 0
+61 2 46203792
Email 9288 0
[email protected]
Contact person for scientific queries
Name 216 0
Joel Radford
Address 216 0
School of Exercise and Health Sciences
University of Western Sydney
Campbelltown Campus
Building 24
Locked Bag 1797
Penrith South DC NSW 1797
Country 216 0
Australia
Phone 216 0
+61 2 46203790
Fax 216 0
+61 2 46203792
Email 216 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.