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Trial registered on ANZCTR
Registration number
ACTRN12617000385347
Ethics application status
Approved
Date submitted
13/03/2017
Date registered
15/03/2017
Date last updated
7/07/2021
Date data sharing statement initially provided
7/07/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Shoe inserts for kneecap arthritis: The FOOTPATH Study
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Scientific title
The efficacy of foot orthoses for patellofemoral osteoarthritis: a randomised controlled trial
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Secondary ID [1]
290669
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APP1106852 (NHMRC)
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Universal Trial Number (UTN)
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Trial acronym
FOOTPATH (FOot OrThoses for PAtellofemoral osteoarTHritis)
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Linked study record
ACTRN12616001287426
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Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the patellofemoral joint
301201
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Condition category
Condition code
Musculoskeletal
300960
300960
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0
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Osteoarthritis
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Physical Medicine / Rehabilitation
302049
302049
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0
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Physiotherapy
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants will receive contoured shoe inserts (foot orthoses) from a commercially available range (Vasyli International, Labrador, Australia). The inserts are manufactured from ethylene-vinyl acetate (EVA) of high, medium and low density, and have an inbuilt arch support and 6 varus wedging. A variety of lengths and shapes are available to fit the shape of different footwear. Study practitioners (Podiatrists, Physiotherapists) will fit contoured inserts to the participants’ shoes, following a prescription algorithm that emphasises comfort. Comfort can be enhanced through the addition of wedges to the forefoot, rearfoot or heel, or by gentle heat moulding. Where possible, the inserts will be able to be transferred across their usual footwear. Participants will be given written instructions for using and adapting to the inserts, and will be advised to wear the inserts as much as possible for the duration of the study (12 months).
To reflect current clinical practice, and to provide sufficient opportunity to ensure adequate comfort and prescribe additional inserts, participants will attend up to 6 appointments (each approx. 20-30 mins duration) with the study practitioner in their private clinic, in the initial phases of the study. Participants will be provided with up to 4 pairs of contoured inserts, fitted to multiple pairs of commonly worn shoes, in order to maximise wear time.
Participants with a high BMI (30 kg/m2) will attend a follow-up appointment 6 months after randomisation to receive new inserts. This will not be necessary for those with a BMI <30 kg/m2, as the pressure-redistributing properties of the contoured inserts are maintained after 12 months.
To maximise outcomes of wearing a comfortable, contoured device, participants will receive one pair of sandals from the Vionics range (Vionics International, San Francisco, USA). Participants will be encouraged to wear these during times that they do not normally wear enclosed footwear (e.g. at home).
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Intervention code [1]
297405
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Treatment: Devices
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Comparator / control treatment
Flat inserts will be used as the comparator intervention. This is because the contour and wedging of the contoured inserts are proposed to exert mechanical effects on the foot and lower limb, which is thought to be the basis for symptom improvement. The flat insert should have no mechanical effect, but has potential to provide enhanced sensory feedback and shock attenuation. The flat insert will have identical covering fabric to the contoured inserts. To control for gradual contouring that occurs with repeated wear of low-density inserts (a limitation of previous studies), the flat inserts will be made of high-density EVA. Standardised guidelines for fitting and follow-up of the flat inserts will be followed by study practitioners to ensure comfort.
To provide sufficient opportunity to ensure adequate comfort and prescribe additional inserts, and ensure consistent practitioner contact time for both insert conditions, participants will attend up to 6 appointments (each approx. 20-30 mins duration) with the study practitioner in their private clinic, in the initial phases of the study. Participants will be provided with up to 4 pairs of contoured inserts, fitted to multiple pairs of commonly worn shoes, in order to maximise wear time. At 6-months post-randomisation, a follow-up appointment will be made and all inserts replaced.
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Control group
Active
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Outcomes
Primary outcome [1]
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Worst knee pain severity during a self-nominated aggravating activity in the previous week. Participants will nominate one of three everyday activities that they experience the greatest pain severity (rising from sitting, squatting, stair ambulation). Pain severity will be measured on a 100mm VAS (terminal descriptors 0=no pain, 100=worst pain possible).
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Assessment method [1]
301447
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Timepoint [1]
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Baseline, 6 weeks, 3 months (primary timepoint), 12 months
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Secondary outcome [1]
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Self-reported global rating of change will be measured on a 7-point Likert scale (‘much better’, ‘better’, ‘a little better’, ‘same’, ‘a little worse’, ‘worse’, ‘much worse’). This will be dichotomised to ‘improved’ (‘much better’, ‘better’) and ‘not improved’ ‘a little better’ to ‘much worse’).
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Assessment method [1]
332684
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Timepoint [1]
332684
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6 weeks, 3 months, 12 months
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Secondary outcome [2]
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Participants will complete a series of pain visual analogue scales, rating the severity of their knee pain on a 100mm scale (terminal descriptors 0=no pain, 100=worst pain possible). This will include: (i) usual pain over the past week; (ii) worst pain over the past week; (iii) maximum pain when walking; (iv) maximum pain when sitting for one hour; (v) maximum pain when rising from sitting; (vi) maximum pain when going up and down stairs; (vii) maximum pain when squatting; (viii) maximum pain when running.
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Assessment method [2]
332685
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Timepoint [2]
332685
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Baseline, 6 weeks, 3 months, 12 months
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Secondary outcome [3]
332686
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Knee injury and Osteoarthritis Outcome Score (KOOS). The KOOS has five subscales: symptoms, pain, function in daily activities, function in sport/recreation, and knee-related quality of life. Participants will also complete the KOOS-PF, a subscale developed for patellofemoral pain and osteoarthritis.
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Assessment method [3]
332686
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Timepoint [3]
332686
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Baseline, 3 months, 12 months
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Secondary outcome [4]
332687
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Anterior Knee Pain Scale (Kujala Patellofemoral Score)
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Assessment method [4]
332687
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Timepoint [4]
332687
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Baseline, 3 months, 12 months
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Secondary outcome [5]
332688
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Arthritis Self-Efficacy Scale
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Assessment method [5]
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Timepoint [5]
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Baseline, 3 months, 12 months
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Secondary outcome [6]
332689
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Tampa Scale for Kinesiophobia
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Assessment method [6]
332689
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Timepoint [6]
332689
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Baseline, 3 months, 12 months
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Secondary outcome [7]
332690
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Health-related quality of life will be measured using the Short-Form 12 version 2
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Assessment method [7]
332690
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Timepoint [7]
332690
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Baseline, 3 months, 12 months
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Secondary outcome [8]
332691
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Health-related quality of life will be evaluated with Euroqol-5D-5L
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Assessment method [8]
332691
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Timepoint [8]
332691
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Baseline, 3 months, 6 months, 9 months, 12 months
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Secondary outcome [9]
332692
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Use of co-interventions for knee pain. The number of participants who report using co-interventions specifically for their knee pain (e.g. medication, allied health services such as physiotherapy, complementary medicines such as osteopathy, topical medicines, or taping/bracing) will be recorded from a number of sources (e.g. participant log-books, 3-monthly questionnaires, 3-monthly telephone interviews)
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Assessment method [9]
332692
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Timepoint [9]
332692
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3 months, 12 months
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Secondary outcome [10]
332693
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Adverse events (e.g. new pains in the body, rolled ankles, blisters, swelling) will be recorded from a number of sources specifically designed for this study (e.g. participant log-books, 3-monthly questionnaires, 3-monthly telephone interviews)
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Assessment method [10]
332693
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Timepoint [10]
332693
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3 months, 6 months, 9 months, 12 months
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Secondary outcome [11]
332694
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Direct health care costs will be captured from multiple sources, for use in economic analyses: (i) Medicare Australia and Pharmaceutical Benefits Scheme (PBS) databases; (ii) participant self-report (monthly log-books; 3-monthly telephone interviews); and (iii) costs associated with delivering the study intervention.
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Assessment method [11]
332694
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Timepoint [11]
332694
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Over 12-month follow-up period
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Secondary outcome [12]
332695
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The Institute for Medical Technology Assessment (iMTA) Productivity Cost Questionnaire will be used to capture indirect / productivity costs
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Assessment method [12]
332695
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Timepoint [12]
332695
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3 months, 6 months, 9 months, 12 months
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Secondary outcome [13]
332696
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Borkovec and Nau questionnaire. This consists of 6 items related to the credibility and expectancy of treatment received
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Assessment method [13]
332696
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Timepoint [13]
332696
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Baseline, 3 months, 12 months
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Secondary outcome [14]
344580
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Physical activity will be monitored in a subgroup of participants (n=60) using a Fitbit® physical activity monitor. The primary outcome of this sub-study will be recruitment rates into the sub-study from the larger trial, and Fitbit® adherence. The sub-study was commenced after enrolment of 39 participants.
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Assessment method [14]
344580
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Timepoint [14]
344580
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3 months
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Secondary outcome [15]
344581
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Physical activity will be monitored in a subgroup of participants (n=60) using a Fitbit® physical activity monitor. Data relating to physical activity levels (e.g. steps) will be extracted weekly for each participant, for the first three months after randomisation. The secondary outcome of this sub-study will be changes in daily steps. The sub-study was commenced after enrolment of 39 participants.
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Assessment method [15]
344581
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Timepoint [15]
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Weekly over 3 months
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Eligibility
Key inclusion criteria
Inclusion criteria are: (i) age 50 years and over; (ii) predominant symptom anterior or retropatellar knee pain aggravated by at least two PF joint loading activities (e.g. stairs, squatting, rising from sitting); (iii) pain present during these activities on most days of the previous month; (iv) pain severity of at least 3 on an 11-point numerical rating scale (NRS, 0-10) during aggravating activities; (v) duration of symptoms of at least 3 months; (vi) either no morning joint-related stiffness, or morning stiffness that lasts no longer than 30 minutes.
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Minimum age
50
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Volunteers will be excluded if they have: (i) knee pain symptoms predominantly from other knee (tibiofemoral joint [TFJ]) structures, hip or lumbar spine; (ii) knee injections or use of shoe inserts within the previous 3 months; (iii) recent commencement of new physiotherapy treatment for PF pain (i.e. new intervention, or modifications to an existing intervention such as therapeutic exercise); (iv) any foot condition precluding the use of shoe inserts; (v) history of lower limb surgery involving major reconstructive procedure (e.g. anterior cruciate ligament reconstruction, osteotomy, arthroplasty); (vi) planned lower limb surgery in the following 12 months; (vii) neurological or systemic arthritis conditions; or (viii) contraindications to x-ray (pregnancy, breastfeeding).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
To ensure allocation concealment, participants will be allocated to the intervention or control group after collection of baseline measures, using an interactive voice response telephone service provided by the NHMRC Clinical Trials Centre (central randomisation).
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The National Health and Medical Research Council (NHMRC) Clinical Trials Centre at the University of Sydney (Australia) will generate the randomisation sequence (minimisation).
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
3/04/2017
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Actual
13/04/2017
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Date of last participant enrolment
Anticipated
31/12/2018
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Actual
15/08/2019
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Date of last data collection
Anticipated
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Actual
24/08/2020
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Sample size
Target
160
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Accrual to date
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Final
159
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Recruitment in Australia
Recruitment state(s)
QLD,TAS,VIC
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Recruitment postcode(s) [1]
15574
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3086 - La Trobe University
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Recruitment postcode(s) [2]
15575
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4072 - University Of Queensland
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Recruitment postcode(s) [3]
22102
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7000 - Hobart
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Funding & Sponsors
Funding source category [1]
295902
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Government body
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Name [1]
295902
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National Health and Medical Research Council
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Address [1]
295902
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GPO Box 1421
Canberra ACT 2601
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Country [1]
295902
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Australia
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Primary sponsor type
University
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Name
La Trobe University
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Address
La Trobe University
Plenty Road & Kingsbury Drive
Melbourne, VIC 3086
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Country
Australia
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Secondary sponsor category [1]
294775
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Individual
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Name [1]
294775
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Kay Crossley
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Address [1]
294775
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La Trobe University
Plenty Road & Kingsbury Drive
Melbourne, VIC 3086
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Country [1]
294775
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
297183
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La Trobe University Human Ethics Committee
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Ethics committee address [1]
297183
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La Trobe University Plenty Road & Kingsbury Drive Melbourne, VIC 3086
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Ethics committee country [1]
297183
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Australia
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Date submitted for ethics approval [1]
297183
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11/10/2016
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Approval date [1]
297183
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25/11/2016
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Ethics approval number [1]
297183
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HEC16-113
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Ethics committee name [2]
299956
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Human Research Ethics Committee
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Ethics committee address [2]
299956
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Human Ethics Research Office Cumbrae-Stewart Building #72 The University of Queensland St Lucia, QLD 4072
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Ethics committee country [2]
299956
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Australia
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Date submitted for ethics approval [2]
299956
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02/03/2017
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Approval date [2]
299956
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05/04/2017
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Ethics approval number [2]
299956
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2017000284
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Summary
Brief summary
Patellofemoral osteoarthritis (PF OA) is a leading cause of pain, disability and health expenditure in Australia, has no cure, and there is little evidence for effective treatments. Pilot data shows that simple contoured shoe inserts (foot orthoses) worn in everyday footwear can reduce pain in older adults with PF OA immediately and after 2 months of wear. This clinical trial will investigate whether contoured shoe inserts are an efficacious longer-term intervention for PF OA. The primary aim is to compare the 3-month efficacy of prefabricated, contoured shoe inserts to flat shoe inserts for reducing the severity of knee pain in people with PF OA. The FOOTPATH trial is a multicentre, randomised, controlled, assessor-blinded superiority trial with two parallel groups and 12-month follow-up. 160 participants aged 50 years and older will be randomly allocated to receive either contoured shoe inserts or flat shoe inserts. Outcomes will be evaluated at 3 and 12 months. Secondary aims will compare the 3- and 12-month effects of contoured inserts and flat inserts on pain, global improvement, function, quality of life, self-efficacy, kinesiophobia, adverse events and use of co-interventions, while cost-effectiveness will be evaluated at 12 months.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
70906
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Prof Kay Crossley
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Address
70906
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La Trobe Sport and Exercise Medicine Research Centre (LASEM)
College of Science, Health and Engineering
School of Allied Health
La Trobe University
Plenty Road & Kingsbury Drive
Melbourne, VIC 3086
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Country
70906
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Australia
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Phone
70906
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+61 3 9479 3902
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Fax
70906
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Email
70906
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k.crossley@latrobe.edu.au
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Contact person for public queries
Name
70907
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Jade Tan
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Address
70907
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La Trobe Sport and Exercise Medicine Research Centre (LASEM)
College of Science, Health and Engineering
School of Allied Health
La Trobe University
Plenty Road & Kingsbury Drive
Melbourne, VIC 3086
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Country
70907
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Australia
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Phone
70907
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+61 3 9479 2768
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Fax
70907
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Email
70907
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jade.tan@latrobe.edu.au
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Contact person for scientific queries
Name
70908
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Kay Crossley
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Address
70908
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La Trobe Sport and Exercise Medicine Research Centre (LASEM)
College of Science, Health and Engineering
School of Allied Health
La Trobe University
Plenty Road & Kingsbury Drive
Melbourne, VIC 3086
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Country
70908
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Australia
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Phone
70908
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+61 3 9479 3902
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Fax
70908
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Email
70908
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k.crossley@latrobe.edu.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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No/undecided IPD sharing reason/comment
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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
Source
Title
Year of Publication
DOI
Embase
The FOOTPATH study: Protocol for a multicentre, participant- and assessor-blind, parallel group randomised clinical trial of foot orthoses for patellofemoral osteoarthritis.
2019
https://dx.doi.org/10.1136/bmjopen-2018-025315
N.B. These documents automatically identified may not have been verified by the study sponsor.
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