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Trial registered on ANZCTR


Trial ID
ACTRN12606000091505
Ethics application status
Approved
Date submitted
3/03/2006
Date registered
7/03/2006
Date last updated
7/03/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of foot orthoses for plantar fasciitis: a randomised trial
Scientific title
Effectiveness on pain and function of foot orthoses for 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 1055 0
Condition category
Condition code
Musculoskeletal 1136 1136 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Foot orthoses for a 12 month intervention period:

(ii) prefabricated orthosis (firm foam),
(iii) customized orthosis (semi-rigid, plastic)
Intervention code [1] 928 0
None
Comparator / control treatment
Foot orthoses for a 12 month intervention period:
(i) sham orthosis (soft, thin foam),
Control group
Placebo

Outcomes
Primary outcome [1] 1521 0
Pain and Function (Foot Health Status Questionnaire)
Timepoint [1] 1521 0
At 3 and 12 months
Secondary outcome [1] 2754 0
Pain and Function
Timepoint [1] 2754 0
At 1 and 6 months (Foot Health Status Questionnaire).
Secondary outcome [2] 2755 0
General Foot Health
Timepoint [2] 2755 0
At 1, 3, 6 and 12 months (Foot Health Status Questionnaire).
Secondary outcome [3] 2756 0
Physical Function
Timepoint [3] 2756 0
At 1, 3, 6 and 12 months (SF-36).
Secondary outcome [4] 2757 0
General Health
Timepoint [4] 2757 0
At 1, 3, 6 and 12 months (SF-36).
Secondary outcome [5] 2758 0
Vitality
Timepoint [5] 2758 0
At 1, 3, 6 and 12 months (SF-36).
Secondary outcome [6] 2759 0
Social functioning
Timepoint [6] 2759 0
At 1, 3, 6 and 12 months (SF-36).

Eligibility
Key inclusion criteria
Participants needed to have a clinical diagnosis of plantar fasciitis and had suffered symptoms for at least four weeks.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
They were excluded if they had a history of a major orthopaedic or medical condition (e.g. inflammatory arthritis or diabetes) that may have influenced the condition.

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)
After recruiting a participant, allocation provided by e-mail or phone by a person not directly involved in the trial
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple - generated using the random number function on Microsoft Excel
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Placebo was a sham foot orthosis
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1237 0
Charities/Societies/Foundations
Name [1] 1237 0
Australian Podiatry Education and Research Foundation
Address [1] 1237 0
Country [1] 1237 0
Australia
Funding source category [2] 1238 0
University
Name [2] 1238 0
University of Western Sydney
Address [2] 1238 0
Country [2] 1238 0
Australia
Funding source category [3] 1239 0
Commercial sector/Industry
Name [3] 1239 0
Orthotic Laboratory
Address [3] 1239 0
Country [3] 1239 0
Australia
Funding source category [4] 1240 0
Commercial sector/Industry
Name [4] 1240 0
Foot Science International
Address [4] 1240 0
Country [4] 1240 0
New Zealand
Funding source category [5] 1241 0
Commercial sector/Industry
Name [5] 1241 0
Allied Health Industries
Address [5] 1241 0
Country [5] 1241 0
Australia
Primary sponsor type
Individual
Name
Dr Karl B Landorf
Address
Country
Secondary sponsor category [1] 1095 0
Individual
Name [1] 1095 0
Anne-Maree Keenan
Address [1] 1095 0
Country [1] 1095 0
Secondary sponsor category [2] 1096 0
Individual
Name [2] 1096 0
Dr Robert D Herbert
Address [2] 1096 0
Country [2] 1096 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2573 0
University of Western Sydney
Ethics committee address [1] 2573 0
Ethics committee country [1] 2573 0
Australia
Date submitted for ethics approval [1] 2573 0
Approval date [1] 2573 0
13/04/1999
Ethics approval number [1] 2573 0
99/012

Summary
Brief summary
Plantar fasciitis is a condition that causes pain in the arch or heel of the foot. It is commonly treated by using foot orthoses (orthotics or shoe insoles). This trial aimed to evaluate the effect of three types of foot orthoses used to treat plantar fasciitis. The trial’s primary hypotheses were (i) do commonly prescribed foot orthoses reduce pain in people with plantar fasciitis, and (ii) do commonly prescribed foot orthoses improve function in people with plantar fasciitis. The trial assessed changes in pain and function in both the short-term (i.e. after 3 months of treatment) and the long-term (i.e. after 12 months of treatment).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36227 0
Address 36227 0
Country 36227 0
Phone 36227 0
Fax 36227 0
Email 36227 0
Contact person for public queries
Name 10117 0
Dr Karl B Landorf
Address 10117 0
Department of Podiatry
School of Human Biosciences
La Trobe University
VIC 3086
Country 10117 0
Australia
Phone 10117 0
+61 3 94795300
Fax 10117 0
+61 3 94795784
Email 10117 0
k.landorf@latrobe.edu.au
Contact person for scientific queries
Name 1045 0
Dr Karl B Landorf
Address 1045 0
Department of Podiatry
School of Human Biosciences
La Trobe University
VIC 3086
Country 1045 0
Australia
Phone 1045 0
+61 3 94795300
Fax 1045 0
+61 3 94795784
Email 1045 0
k.landorf@latrobe.edu.au