Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000024549
Ethics application status
Approved
Date submitted
17/12/2014
Date registered
16/01/2015
Date last updated
13/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The Australian Navy Cerberus Orthotic Research (ANCOR) study: a randomised trial of foot orthoses for the prevention of overuse lower limb injuries in naval recruits
Scientific title
Comparison of the effectiveness of prefabricated foot orthoses versus flat insoles for the prevention of overuse lower limb injuries in naval recruits undertaking basic training
Secondary ID [1] 285858 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
The ANCOR study: a randomised trial of foot orthoses for the prevention of overuse lower limb injuries in naval recruits
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lower limb injuries 293772 0
Condition category
Condition code
Musculoskeletal 294075 294075 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 294076 294076 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive a pair of Formthotics (Registered Trademark) prefabricated foot orthoses (Foot Science International, Christchurch, New Zealand). The insoles will be full-length insoles made from 140 kg/m3 single density, closed cell polyethylene foam. Each participant will have their foot orthoses fitted to their athletic shoes and Defence-issued boots (i.e. two pairs of insoles per participant). All participants will be asked to wear the foot orthoses as often as possible during the 11 week trial. Adherence to the insoles will be documented by participants in weekly self-report diaries and navy medical records. In addition, adherence to the insoles will be confirmed with a blinded assessor at weeks 2 and 11.
Intervention code [1] 290839 0
Prevention
Comparator / control treatment
The control group will receive 3 mm flat insoles. The flat insoles will be manufactured by the same company as the prefabricated foot orthoses (Foot Science International, Christchurch, New Zealand), will be full-length insoles and will be made from 140 kg/m3 single density, closed cell polyethylene foam. The flat insoles will be fitted to the participant’s athletic shoes and Defence-issued boots (i.e. two pairs of insoles per participant). All participants will be asked to wear the flat insoles as often as possible during the trial.
Control group
Placebo

Outcomes
Primary outcome [1] 293859 0
The combined incidence of four common lower limb injuries (medial tibial stress syndrome, patello-femoral joint pain, Achilles tendinopathy, and plantar fasciitis/plantar heel pain) as determined at medical appointments and by assessors at the exit interview (week 11). The diagnosis of medial tibial stress syndrome, patello-femoral joint pain, Achilles tendinopathy, and plantar fasciitis/plantar heel pain will be determined by clinical assessment.
Timepoint [1] 293859 0
Week 11
Secondary outcome [1] 312012 0
The overall incidence of over-use lower limb pain as determined by pain drawings in self-report diaries
Timepoint [1] 312012 0
Week 11
Secondary outcome [2] 312013 0
The severity (usual and worst) of over-use lower limb pain as determined by the 100 mm visual analogue scale in self-report diaries
Timepoint [2] 312013 0
Week 11
Secondary outcome [3] 312014 0
The time (in days) to lower limb injury and pain as determined by self-report diaries and navy medical records
Timepoint [3] 312014 0
Weeks 1-11
Secondary outcome [4] 312015 0
Time (in days) to drop-out from injury as determined by navy administration records
Timepoint [4] 312015 0
Weeks 1-11
Secondary outcome [5] 312016 0
The type, frequency and severity (mild, moderate, or severe) of self-reported adverse events (such as new pains, shoe/insole discomfort and blisters) will be obtained from self-report diaries, medical record records and during assessment sessions in weeks 2 and 11.
Timepoint [5] 312016 0
Weeks 1-11
Secondary outcome [6] 312017 0
Lost training days as determined by navy administration and medical records
Timepoint [6] 312017 0
Weeks 1-11
Secondary outcome [7] 312019 0
Shoe comfort will be measured using a 100 mm Visual Analogue Scale
Timepoint [7] 312019 0
At baseline, Weeks 2 and 11
Secondary outcome [8] 312020 0
Health status will be determined using the Short-Form-12 Version 2 questionnaire
Timepoint [8] 312020 0
At baseline and week 11

Eligibility
Key inclusion criteria
All naval recruits undertaking 11 weeks of basic training at HMAS Cerberus will be invited to participate in the trial
Minimum age
17 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they wear foot orthoses or have a lower limb injury (worst pain at least 30 mm on a 100 mm visual analogue scale) at the time of recruitment

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomly assigned to either the prefabricated foot orthoses or flat insoles. To ensure allocation concealment, an interactive voice response telephone service provided by the National Health and Medical Research Council Clinical Trials Centre (University of Sydney, New South Wales, Australia) will be used.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation with random block sizes will be undertaken using an interactive voice response telephone service provided by the National Health and Medical Research Council Clinical Trials Centre (University of Sydney, New South Wales, Australia).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
A prospective sample size calculation has estimated that 306 participants (i.e. approximately 153 participants per group) are required to provide 80% power to detect a clinically worthwhile difference (alpha set at 5%). The sample size for the study was calculated assuming: (i) a combined incidence of injury of 30% for medial tibial stress syndrome, patello-femoral joint pain, Achilles tendinopathy, and plantar fasciitis/plantar heel pain, (ii) a 50% reduction in injury in the intervention group, and (iii) a drop-out rate of 20%.

Statistical analysis will be performed using the intention-to-treat principle for all randomised participants. The endpoint will be the completion of the 11 weeks of basic training for each participant. Multiple imputation will be used to replace any missing data using five iterations, with age, and group allocation as predictors. Participant characteristics and baseline data will be summarised by descriptive statistics. Distribution of continuous variables will be checked and transformation carried out if necessary. Differences in the primary and secondary outcome measures between the two groups will be compared. The proportion of participants developing lower limb injuries during the 11 week training period in each group will be compared using relative risks. Comfort and adherence of the shoe insole interventions will be analysed using independent t-tests, and chi-square analyses, respectively. Effect sizes will be determined using standardised mean differences for continuous scaled data and risk ratios for nominal scaled data. Hypothesis tests will be considered significant if p < 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/01/2015
Actual
26/01/2015
Date of last participant enrolment
Anticipated
Actual
4/06/2015
Date of last data collection
Anticipated
Actual
14/08/2015
Sample size
Target
306
Accrual to date
Final
306
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 9062 0
3920 - Hmas Cerberus

Funding & Sponsors
Funding source category [1] 290431 0
University
Name [1] 290431 0
La Trobe University Sport, Exercise and Rehabilitation Research Focus Area
Country [1] 290431 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University, Bundoora, Victoria, 3086
Country
Australia
Secondary sponsor category [1] 289143 0
None
Name [1] 289143 0
Address [1] 289143 0
Country [1] 289143 0
Other collaborator category [1] 278268 0
Government body
Name [1] 278268 0
Royal Australian Navy Recruit School
Address [1] 278268 0
Cerberus, Victoria, 3920
Country [1] 278268 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292113 0
Australian Defence Human Research Ethics Committee
Ethics committee address [1] 292113 0
Ethics committee country [1] 292113 0
Australia
Date submitted for ethics approval [1] 292113 0
Approval date [1] 292113 0
20/10/2014
Ethics approval number [1] 292113 0
764-14

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

Contacts
Principal investigator
Name 53582 0
Mr Daniel R Bonanno
Address 53582 0
Department of Podiatry, College of Science Health and Engineering, La Trobe University, Bundoora, Victoria, 3086
Country 53582 0
Australia
Phone 53582 0
+61 3 9479 5839
Fax 53582 0
Email 53582 0
[email protected]
Contact person for public queries
Name 53583 0
Daniel R Bonanno
Address 53583 0
Department of Podiatry, College of Science Health and Engineering, La Trobe University, Bundoora, Victoria, 3086
Country 53583 0
Australia
Phone 53583 0
+61 3 9479 5839
Fax 53583 0
Email 53583 0
[email protected]
Contact person for scientific queries
Name 53584 0
Daniel R Bonanno
Address 53584 0
Department of Podiatry, College of Science Health and Engineering, La Trobe University, Bundoora, Victoria, 3086
Country 53584 0
Australia
Phone 53584 0
+61 3 9479 5839
Fax 53584 0
Email 53584 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.