Trial Review

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
ACTRN12607000319471
Ethics application status
Approved
Date submitted
1/06/2007
Date registered
18/06/2007
Date last updated
18/06/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of Customized and Prefabricated Foot Orthoses in Plantar Fasciitis.
Scientific title
Efficacy of Customized and Prefabricated Foot Orthoses in Plantar Fascitis: a Double-Blind Randomized Clinical Trial.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plantar fasciitis; Pain. 1865 0
Condition category
Condition code
Musculoskeletal 1961 1961 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One hundred and forty-two patients were randomly allocated to wear a prefabricated (intervention group) or a control, for eight weeks, both made in EVA.
Intervention code [1] 1799 0
Treatment: Devices
Comparator / control treatment
A customized foot orthosis (control group).
Control group
Active

Outcomes
Primary outcome [1] 2776 0
The primary outcome was pain measured by the pain sub-scale of the Foot Function Index (FFI-pain)
Timepoint [1] 2776 0
At baseline, week 4 and week 8.
Secondary outcome [1] 4676 0
The secondary outcome was pain due to palpation in the medial calcaneal tuberosity, measured by a visual analog scale.
Timepoint [1] 4676 0
Assessed at baseline, weeks 4 and 8.

Eligibility
Key inclusion criteria
A confirmed diagnosis of plantar fasciitis, who had experienced symptoms for at least 1 week.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with history of malignancy, pregnancy, inflammatory arthritis.

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)
The trial was conducted in a Rehabilitation Hospital and consecutive patients with the diagnosis of plantar fasciitis for at least 1 week were invited to participate. After accepting the invitation, the patients were evaluated and assigned to the treatment group according to the randomization. Allocation was concealed using opaque and sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
the people receiving the treatments and the people assessing the outcomes were blinded in the study
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2100 0
Hospital
Name [1] 2100 0
Sarah Network Hospitals of Rehabilitation
Country [1] 2100 0
Brazil
Primary sponsor type
Individual
Name
Paulo SS Beraldo
Address
Country
Secondary sponsor category [1] 1907 0
Individual
Name [1] 1907 0
Valéria Baldassin
Address [1] 1907 0
Country [1] 1907 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Background: Foot orthoses are a modality of treatment frequently used mainly to relieve the pain caused by plantar fasciitis. This randomized trial evaluated the effectiveness of prefabricated and customized foot orthoses made in ethylene vinyl acetate (EVA), a cheap raw material not commonly cited in previous trials.
Methods: A double-blinded, randomized trial was conducted from May 2004 to July 2005. Each participant was reviewed at four and eight weeks after the initial appointment. One hundred and forty-two patients were randomly allocated to receive a prefabricated or a customized foot orthosis, both made in EVA. The primary and secondary outcomes were pain, both measured by a visual analog scale and the previous was measured by the pain sub-scale of the Foot Function Index (FFI-pain) and later by palpation in the medial calcaneal tuberosity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27902 0
Address 27902 0
Country 27902 0
Phone 27902 0
Fax 27902 0
Email 27902 0
Contact person for public queries
Name 10988 0
Valeria Baldassin
Address 10988 0
Setor Medico Hospitalar Sul
Quadra 501 bloco A
Brasília-DF
Country 10988 0
Brazil
Phone 10988 0
55 61 33191639
Fax 10988 0
Email 10988 0
[email protected]
Contact person for scientific queries
Name 1916 0
Paulo Sergio Siebra Beraldo
Address 1916 0
Setor Medico Hospitalar Sul
Quadra 501 bloco A
Brasília-DF
Country 1916 0
Brazil
Phone 1916 0
55 61 33191424
Fax 1916 0
Email 1916 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.