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Trial registered on ANZCTR


Registration number
ACTRN12613000446763
Ethics application status
Approved
Date submitted
10/04/2013
Date registered
18/04/2013
Date last updated
18/04/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of three different methods of managing heel pain
Scientific title
The effect of foot orthotics and new neutral athletic footwear versus control on first step pain in individuals with plantar fasciopathy
Secondary ID [1] 281738 0
None
Universal Trial Number (UTN)
U1111-1138-3436
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plantar fasciopathy
 288044 0
Condition category
Condition code
Musculoskeletal 288421 288421 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1 - Customised foot orthotics + new neutral athletic footwear - medical devices used to relieve the stresses on pathologiccal tissues. These devices will be placed in new neutral athletic footwear and worn in both feet. Duration of the intervention period is 12 weeks. To be worn every day for as much as possible. Compliance and amount worn will be monitored as average time worn per day in an online pain diary to be completed weekly.
Arm 2 - New neutral athletic footwear - athletic running shoe with no added medial support or midsole dual density. Duration of the intervention period is 12 weeks. Shoes to be worn every day as much as possible.
Compliance and amount worn will be monitored as average time worn per day in an online pain diary to be completed weekly.
Intervention code [1] 286276 0
Treatment: Devices
Comparator / control treatment
Participants wearing there own shoes with no modifications made. There own shoes will be worn as much as possible and compliance will be monitored weekly by an online pain diary
Control group
Active

Outcomes
Primary outcome [1] 288587 0
First step pain underneath the heel. Assessed as the average first step pain on a 100mm visual analogue scale. This is done weekly on an online pain diary
Timepoint [1] 288587 0
four-weeks, 12-weeks and 52-weeks from baseline
Secondary outcome [1] 300542 0
Average 24-hour pain. Assessed via a 100mm VAS
Timepoint [1] 300542 0
four-weeks and 12-weeks from baseline
Secondary outcome [2] 302378 0
Thickness of the plantar fascia on ultrasound. Assessed by diagnostic ultrasound
Timepoint [2] 302378 0
baseline, 4-week and 12-week timepoints
Secondary outcome [3] 302379 0
Medial longitudinal arch angle. Assessed as the angle betwene three markers placed on the calcaneus, navicular tuberosity and 1st metatarsal head tracked by a 3-D motion capture system.
Timepoint [3] 302379 0
With and without the intervention at baseline, and 12-weeks
Secondary outcome [4] 302380 0
Duration and loading rate of 1st rocker period. Defined by a force platform in terms of the loading rate (rate of change) of the vertical component of the vertical ground reaction force. Duration defined as the time from initial contact to 15% of contact time
Timepoint [4] 302380 0
Baseline and 12-weeks with and without intervention
Secondary outcome [5] 302381 0
Maximum tibiocalcaneal joint eversion angle & corresponding joint moment. Assessed using motion capture software and force platforms
Timepoint [5] 302381 0
With and without intervention at baseline and 12-weeks
Secondary outcome [6] 302382 0
Peak tibiocalcaneal joint flexion/extension angle & corresponding joint moment. Assessed with motion capture technology and a force platform.
Timepoint [6] 302382 0
With and without intervention at baseline and 12-weeks

Eligibility
Key inclusion criteria
Aged between 18 - 60 years of age
Heel pain in only one foot
Duration of symptoms > four weeks
Self-reported heel pain > 20 mm on A 100mm VAS
Report pain on palpation of the medial tubercle of the calcaneus or proximal plantar fascia
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Purchase of new athletic shoes or foot orthotics in last four weeks
Treatment within the last four weeks
Pregnancy
Diagnosis of Diabetes Type I or II
Diagnosis of any inflammatory arthropathies
History of neurological or neuromuscular conditions affecting lower limb biomechanics
History of corticosteroid injection in the heel < 6 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)
Open public recruitment. Interested volunteers present for screening and if eligible, is randomly allocated to group. Group allocation run by off site investigator who has access to randomisation sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
A mixed model will be used to describe the differences between conditions. The required sample was determined based on previous literature. The minimal important difference of foot orthotics in decreasing first-pain associated with plantar fasciopathy has been reported as 19 mm on a 100 mm VAS (effect size (d) = 0.8) (Landorf, Radford & Hudson 2010). These data were used to conduct a sample size calculation, indicating a total sample required of 51 participants (17 in each group) with 80% power and alpha set at 0.05. This is a straight mixed model with time and group treated as factors. Subjects are designated as random effects. As intention to treat (ITT) analysis will be used, there is no need to account for participant dropout.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/04/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
51
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 287057 0
Commercial sector/Industry
Name [1] 287057 0
ASICS Oceania
Country [1] 287057 0
Australia
Primary sponsor type
Individual
Name
Chris Bishop
Address
School of Heath Sciences
University of South Australia
City East Campus
North Tce, Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 285838 0
None
Name [1] 285838 0
Address [1] 285838 0
Country [1] 285838 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 36878 0
Mr Chris Bishop
Address 36878 0
School of Health Sciences, University of South Australia, City East Campus

Biomechanics & Neuromotor Labs

Bazil Hetzel Building H1-10 GPO Box 2471 Adelaide 5001
Country 36878 0
Australia
Phone 36878 0
+61 8 83021312
Fax 36878 0
Email 36878 0
christopher.bishop@mymail.unisa.edu.au
Contact person for public queries
Name 36879 0
Chris Bishop
Address 36879 0
School of Health Sciences, University of South Australia, City East Campus

Biomechanics & Neuromotor Labs

Bazil Hetzel Building H1-10 GPO Box 2471 Adelaide 5001
Country 36879 0
Australia
Phone 36879 0
+61 8 83021312
Fax 36879 0
Email 36879 0
christopher.bishop@mymail.unisa.edu.au
Contact person for scientific queries
Name 36880 0
Chris Bishop
Address 36880 0
School of Health Sciences, University of South Australia, City East Campus

Biomechanics & Neuromotor Labs

Bazil Hetzel Building H1-10 GPO Box 2471 Adelaide 5001
Country 36880 0
Australia
Phone 36880 0
+61 8 83021312
Fax 36880 0
Email 36880 0
christopher.bishop@mymail.unisa.edu.au

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
SourceTitleYear of PublicationDOI
EmbaseCustom foot orthoses improve first-step pain in individuals with unilateral plantar fasciopathy: A pragmatic randomised controlled trial.2018https://dx.doi.org/10.1186/s12891-018-2131-6
N.B. These documents automatically identified may not have been verified by the study sponsor.