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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
Scientific title
The efficacy of foot orthoses for patellofemoral osteoarthritis: a randomised controlled trial
Secondary ID [1] 290669 0
APP1106852 (NHMRC)
Universal Trial Number (UTN)
Trial acronym
FOOTPATH (FOot OrThoses for PAtellofemoral osteoarTHritis)
Linked study record
ACTRN12616001287426

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the patellofemoral joint 301201 0
Condition category
Condition code
Musculoskeletal 300960 300960 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 302049 302049 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
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).
Intervention code [1] 297405 0
Treatment: Devices
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.
Control group
Active

Outcomes
Primary outcome [1] 301447 0
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).
Timepoint [1] 301447 0
Baseline, 6 weeks, 3 months (primary timepoint), 12 months
Secondary outcome [1] 332684 0
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’).
Timepoint [1] 332684 0
6 weeks, 3 months, 12 months
Secondary outcome [2] 332685 0
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.
Timepoint [2] 332685 0
Baseline, 6 weeks, 3 months, 12 months
Secondary outcome [3] 332686 0
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.
Timepoint [3] 332686 0
Baseline, 3 months, 12 months
Secondary outcome [4] 332687 0
Anterior Knee Pain Scale (Kujala Patellofemoral Score)
Timepoint [4] 332687 0
Baseline, 3 months, 12 months
Secondary outcome [5] 332688 0
Arthritis Self-Efficacy Scale
Timepoint [5] 332688 0
Baseline, 3 months, 12 months
Secondary outcome [6] 332689 0
Tampa Scale for Kinesiophobia
Timepoint [6] 332689 0
Baseline, 3 months, 12 months
Secondary outcome [7] 332690 0
Health-related quality of life will be measured using the Short-Form 12 version 2
Timepoint [7] 332690 0
Baseline, 3 months, 12 months
Secondary outcome [8] 332691 0
Health-related quality of life will be evaluated with Euroqol-5D-5L
Timepoint [8] 332691 0
Baseline, 3 months, 6 months, 9 months, 12 months
Secondary outcome [9] 332692 0
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)
Timepoint [9] 332692 0
3 months, 12 months
Secondary outcome [10] 332693 0
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)
Timepoint [10] 332693 0
3 months, 6 months, 9 months, 12 months
Secondary outcome [11] 332694 0
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.
Timepoint [11] 332694 0
Over 12-month follow-up period
Secondary outcome [12] 332695 0
The Institute for Medical Technology Assessment (iMTA) Productivity Cost Questionnaire will be used to capture indirect / productivity costs
Timepoint [12] 332695 0
3 months, 6 months, 9 months, 12 months
Secondary outcome [13] 332696 0
Borkovec and Nau questionnaire. This consists of 6 items related to the credibility and expectancy of treatment received
Timepoint [13] 332696 0
Baseline, 3 months, 12 months
Secondary outcome [14] 344580 0
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.
Timepoint [14] 344580 0
3 months
Secondary outcome [15] 344581 0
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.
Timepoint [15] 344581 0
Weekly over 3 months

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.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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).

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)
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).
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).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving 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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/04/2017
Actual
13/04/2017
Date of last participant enrolment
Anticipated
31/12/2018
Actual
15/08/2019
Date of last data collection
Anticipated
Actual
24/08/2020
Sample size
Target
160
Accrual to date
Final
159
Recruitment in Australia
Recruitment state(s)
QLD,TAS,VIC
Recruitment postcode(s) [1] 15574 0
3086 - La Trobe University
Recruitment postcode(s) [2] 15575 0
4072 - University Of Queensland
Recruitment postcode(s) [3] 22102 0
7000 - Hobart

Funding & Sponsors
Funding source category [1] 295902 0
Government body
Name [1] 295902 0
National Health and Medical Research Council
Country [1] 295902 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University
Plenty Road & Kingsbury Drive
Melbourne, VIC 3086
Country
Australia
Secondary sponsor category [1] 294775 0
Individual
Name [1] 294775 0
Kay Crossley
Address [1] 294775 0
La Trobe University
Plenty Road & Kingsbury Drive
Melbourne, VIC 3086
Country [1] 294775 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297183 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 297183 0
Ethics committee country [1] 297183 0
Australia
Date submitted for ethics approval [1] 297183 0
11/10/2016
Approval date [1] 297183 0
25/11/2016
Ethics approval number [1] 297183 0
HEC16-113
Ethics committee name [2] 299956 0
Human Research Ethics Committee
Ethics committee address [2] 299956 0
Ethics committee country [2] 299956 0
Australia
Date submitted for ethics approval [2] 299956 0
02/03/2017
Approval date [2] 299956 0
05/04/2017
Ethics approval number [2] 299956 0
2017000284

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

Contacts
Principal investigator
Name 70906 0
Prof Kay Crossley
Address 70906 0
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
Country 70906 0
Australia
Phone 70906 0
+61 3 9479 3902
Fax 70906 0
Email 70906 0
k.crossley@latrobe.edu.au
Contact person for public queries
Name 70907 0
Jade Tan
Address 70907 0
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
Country 70907 0
Australia
Phone 70907 0
+61 3 9479 2768
Fax 70907 0
Email 70907 0
jade.tan@latrobe.edu.au
Contact person for scientific queries
Name 70908 0
Kay Crossley
Address 70908 0
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
Country 70908 0
Australia
Phone 70908 0
+61 3 9479 3902
Fax 70908 0
Email 70908 0
k.crossley@latrobe.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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
EmbaseThe FOOTPATH study: Protocol for a multicentre, participant- and assessor-blind, parallel group randomised clinical trial of foot orthoses for patellofemoral osteoarthritis.2019https://dx.doi.org/10.1136/bmjopen-2018-025315
N.B. These documents automatically identified may not have been verified by the study sponsor.