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Trial registered on ANZCTR


Registration number
ACTRN12616001287426
Ethics application status
Approved
Date submitted
8/09/2016
Date registered
13/09/2016
Date last updated
18/08/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of shoe inserts on lower limb biomechanics in kneecap arthritis: a pilot study
Scientific title
The effects of foot orthoses on lower limb biomechanics in patellofemoral joint osteoarthritis: a pilot study
Secondary ID [1] 289218 0
None
Universal Trial Number (UTN)
Trial acronym
FOOTPATH
FOot OrThoses for Patellofemoral joint osteoArTHritis
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patellofemoral osteoarthritis 298777 0
Condition category
Condition code
Musculoskeletal 298831 298831 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 300113 300113 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Contoured inserts: Commercially-available, full-length prefabricated foot orthoses (Vasyli Custom Red, Vasyli International, Labrador, Australia) will be inserted into the participants’ shoes. These contoured inserts are made of high density (shore A 75 degrees) ethylene-vinyl acetate (EVA), have an inbuilt arch support, and a 6 degree varus wedge as specified by the manufacturer. A full length piece of Cambrelle [Registered Trademark] (Camtex Fabrics Ltd, United Kingdom) will be applied to the top of the insert to standardize the appearance of the intervention and control inserts.

Participants will attend a single 2.5hr testing appointment at La Trobe University, where a registered Podiatrist with 5 years experience will fit one pair of contoured inserts. Participants will be asked to wear the inserts as much as possible for the study duration (6 weeks), and can transfer the inserts to other footwear. This reflects current clinical practice, and will ensure maximal wear time and potential effects. Participants will be contacted by the Podiatrist 4-7 days after fitting, and offered a follow-up appointment (30min) at La Trobe University to amend any issues with the inserts (e.g. to improve comfort). They will be encouraged to contact the Podiatrist at any time during the follow-up period if they experience any issues with the inserts.

Adherence to the intervention will be assessed daily via a paper-based diary. Participants will provide information regarding the number of hours per day and number of days per week they have worn their shoe inserts during the 6 weeks.
Intervention code [1] 294756 0
Treatment: Devices
Comparator / control treatment
Flat inserts: Participants allocated to the control group will receive a single pair of flat shoe inserts. These are designed to have minimal mechanical effects on the patellofemoral joint, and will control for the contouring of the intervention insert. The flat inserts will also be made of high density EVA (shore A 75 degrees), but will be of uniform thickness along the length (3mm), and have no inbuilt arch or wedging. A full length piece of Cambrelle [Registered Trademark] (Camtex Fabrics Ltd, United Kingdom) will be applied to the top of the insert to standardize the appearance of the intervention and control inserts.

Participants will attend an individual testing appointment at La Trobe University, where a registered Podiatrist with 5 years experience will fit one pair of contoured inserts. Participants will be asked to wear the inserts as much as possible for the study duration (6 weeks), and can transfer the inserts to other footwear. This reflects current clinical practice, and will ensure maximal wear time and potential effects. Participants will be contacted by the Podiatrist 4-7 days after fitting, and offered a follow-up appointment at La Trobe University to amend any issues with the inserts (e.g. to improve comfort). They will be encouraged to contact the Podiatrist at any time during the follow-up period if they experience any issues with the inserts.

Adherence to the intervention will be assessed daily via a paper-based diary. Participants will provide information regarding the number of hours per day and number of days per week they have worn their shoe inserts during the 6 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 298299 0
Knee biomechanics:
Kinematic data will be acquired using skin-based markers and a three-dimensional motion capture system (Vicon), while ground-embedded force plates will capture ground reaction force data simultaneously. Participants will perform level overground walking and stair ascent/descent under three conditions (random order): (i) shoes alone; (ii) contoured inserts; and (iii) flat inserts. Knee kinematics and joint torques will be calculated using standard procedures.
Timepoint [1] 298299 0
Immediate effects (baseline)
Primary outcome [2] 298300 0
Feasibility:
Feasibility will be assessed by evaluating willingness of participants to enrol; number of eligible participants; recruitment rate; adherence with allocated shoe insert and log-book completion; adverse effects; and drop-out rate. The Podiatrist who fits the shoe inserts will record the number of additional appointments required, prescription notes and adverse effects during fitting and follow-up.
Timepoint [2] 298300 0
Baseline through to 6 weeks
Secondary outcome [1] 324833 0
Knee pain severity:
This will be evaluated during biomechanical testing (walking, stair ascent/descent) in both shoe insert conditions and the participants own shoe, using a 100mm visual analogue scales. For pain, terminal descriptors 0mm = no pain, 100mm = worst pain possible.
Timepoint [1] 324833 0
Immediate effects (baseline)
Secondary outcome [2] 324836 0
Knee confidence:
This will be evaluated during biomechanical testing (walking, stair ascent/descent) in both shoe insert conditions and the participants own shoe, using a 100mm visual analogue scales. For confidence, terminal descriptors 0mm = very confident, 100mm = not confident at all.
Timepoint [2] 324836 0
Immediate effects (baseline)
Secondary outcome [3] 324837 0
Credibility of treatment:
This will be evaluated using the Borkovec and Nau questionnaire which consists of 6 items related to the credibility and expectancy of treatment received.
Timepoint [3] 324837 0
Baseline and 6 weeks
Secondary outcome [4] 324838 0
Use of co-interventions:
Participants will use a daily log-book to record the use of any interventions outside those allocated in the study (e.g. rescue medication such as paracetamol; other treatments such as physiotherapy, osteopathy etc.)
Timepoint [4] 324838 0
Daily for 6 weeks
Secondary outcome [5] 326311 0
Knee injury and Osteoarthritis Outcome Score (KOOS):
KOOS is a disease-specific, patient-completed questionnaire consisting of 5 subscales: pain, symptoms, function in daily activities, function in sport/recreation, and knee-related quality of life.
Timepoint [5] 326311 0
Baseline and 6 weeks
Secondary outcome [6] 326312 0
Anterior Knee Pain Scale:
This consists of 13 items with discrete categories related to limp, weight bearing, walking, stairs, squatting, running, jumping, prolonged sitting with flexed knees, pain, swelling, painful patellar movements, thigh muscle atrophy, and flexion deficiency.
Timepoint [6] 326312 0
Baseline and 6 weeks
Secondary outcome [7] 326313 0
Global improvement:
This will be evaluated on a six-point Likert scale (completely recovered, much improved, improved, no change, worse, much worse).
Timepoint [7] 326313 0
6 weeks
Secondary outcome [8] 327646 0
Pain severity:
Pain severity will be evaluated using a series of 100mm visual analogue scales (VAS) (terminal descriptors 0mm = no pain, 100mm = worst pain imaginable). These will relate to usual and worst pain over the preceding week, as well as pain during functional activities (e.g. usual knee pain severity during a self-nominated aggravating activity in the previous week).
Timepoint [8] 327646 0
Baseline and 6 weeks

Eligibility
Key inclusion criteria
Volunteers will be included who have a clinical diagnosis of PF OA, based on NICE guidelines (https://www.nice.org.uk/guidance/cg177). This is to facilitate generalization of findings to clinical practice, without the need for imaging. Inclusion criteria will be based on those used in previous studies of kneecap osteoarthritis : (i) aged 50-75 years; (ii) anterior or retropatellar knee pain aggravated by PFJ-loading activities (e.g. stairs, squatting); (iii) pain during these activities on most days in the past month; and (iv) pain severity at least 30mm on a 100mm visual analogue scale (VAS) during aggravating activities.
Minimum age
50 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) Concomitant pain from other knee structures, hip or lumbar spine; (ii) recent treatment for knee pain (e.g. knee injections within the previous 3 months; shoe inserts within the previous 12 months); (iii) any foot condition precluding the use of shoe inserts; (iv) knee or hip arthroplasty/osteotomy; (v) neurological or systemic arthritis conditions; (vi) physical inability, too frail or ill to undertake testing procedures (ascertained via questioning, and if needed clinical examination); (vii) inability to understand written and spoken English.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation will be obtained by an on-line randomisation website (randomization.com).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Within-subject, repeated measures evaluation of the immediate effects of different shoe inserts on lower limb biomechanics.
Descriptive evaluation of feasibility measures, treatment credibility, and co-interventions.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 13404 0
3086 - La Trobe University

Funding & Sponsors
Funding source category [1] 293597 0
Government body
Name [1] 293597 0
National Health and Medical Research Council (NHMRC)
Address [1] 293597 0
GPO Box 1421
Canberra ACT 2601
Country [1] 293597 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University
Melbourne
VIC 3086
Country
Australia
Secondary sponsor category [1] 292412 0
None
Name [1] 292412 0
Address [1] 292412 0
Country [1] 292412 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295037 0
La Trobe Human Ethics Committee
Ethics committee address [1] 295037 0
La Trobe University
Plenty Road & Kingsbury Drive
Bundoora, VIC 3086
Ethics committee country [1] 295037 0
Australia
Date submitted for ethics approval [1] 295037 0
20/11/2015
Approval date [1] 295037 0
21/12/2015
Ethics approval number [1] 295037 0
UHEC S15/286

Summary
Brief summary
This study will investigate the immediate biomechanical effects of shoe inserts in those with kneecap arthritis, as well as the feasibility of conducting a larger scale clinical trial. Thirty-two participants will be recruited from the Melbourne community, and will remain blinded to the intervention and study hypotheses for the duration of the study.

To investigate the immediate biomechanical effects of shoe inserts in those with kneecap arthritis, a within subject, repeated measures study design will be used. The immediate effects of different shoe inserts on lower limb biomechanics will be obtained using a three-dimensional motion capture system during the baseline appointment. Participants will perform walking and stair-stepping tasks while wearing three different shoe insert conditions applied in a random order: (i) own footwear; (ii) own footwear with contoured shoe inserts; and (iii) own footwear with flat shoe inserts.

To determine the feasibility of conducting a larger scale clinical trial, a parallel group randomised trial with two groups and a 6 week follow up will be used. Following the study of the immediate biomechanical effects of the shoe inserts, participants will then be randomly assigned to one of two shoe insert conditions (contoured inserts, flat inserts), which they will take home and wear in their usual footwear for 6 weeks. The feasibility of conducting a larger clinical trial will be assessed via willingness of participants to enrol in the study, the number of participants who qualify for the study, adherence with use the allocated shoe inserts, shoe insert diary completion, frequency and types of adverse effects, participant attrition, and treatment credibility. The Podiatrist who fits the shoe inserts will record the number of additional appointments required, prescription notes, and adverse effects during fitting and follow-up appointments (if required). Measures of pain severity, function, quality of life, and overall improvement will inform calculation of sample sizes for future larger-scale clinical trials.
Trial website
http://semrc.blogs.latrobe.edu.au/kneecap-pain
Trial related presentations / publications
Public notes
We have now finished recruiting into this trial and are currently analysing the data

Contacts
Principal investigator
Name 65870 0
Prof Kay Crossley
Address 65870 0
La Trobe Sport and Exercise Medicine Research Centre
La Trobe University
Plenty Road & Kingsbury Drive
Bundoora, VIC 3086
Country 65870 0
Australia
Phone 65870 0
+61 3 9479 3902
Fax 65870 0
Email 65870 0
k.crossley@latrobe.edu.au
Contact person for public queries
Name 65871 0
Ms Jade Tan
Address 65871 0
La Trobe Sport and Exercise Medicine Research Centre
La Trobe University
Plenty Road & Kingsbury Drive
Bundoora, VIC 3086
Country 65871 0
Australia
Phone 65871 0
+61 3 9479 2768
Fax 65871 0
Email 65871 0
jade.tan@latrobe.edu.au
Contact person for scientific queries
Name 65872 0
Prof Kay Crossley
Address 65872 0
La Trobe Sport and Exercise Medicine Research Centre
La Trobe University
Plenty Road & Kingsbury Drive
Bundoora, VIC 3086
Country 65872 0
Australia
Phone 65872 0
+61 3 9479 3902
Fax 65872 0
Email 65872 0
k.crossley@latrobe.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary