Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000042640
Ethics application status
Approved
Date submitted
14/12/2022
Date registered
16/01/2023
Date last updated
21/01/2024
Date data sharing statement initially provided
16/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Shoes for adolescent kneecap pain: the SHAPE randomised clinical trial
Scientific title
Effects of minimalist versus motion control shoes in adolescents with patellofemoral pain: a randomised clinical trial
Secondary ID [1] 308252 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SHAPE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patellofemoral pain 328037 0
Condition category
Condition code
Musculoskeletal 325094 325094 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This comparative effectiveness trial will compare two different classes of footwear.

The intervention treatment category is minimalist shoes. The minimalist shoes were selected from commercially available footwear, that fulfill previously published criteria for minimalist shoes (Paterson et al, 2017, Osteoarthritis & Cartilage). These criteria are: 1) heel height of less than 15mm; 2) shoe pitch of less than 10mm; 3) absence of arch support or motion control; 4) have "minimal" sole rigidity (Barton et al. 2009, J Foot Ankle Res); and 5) weigh 200g or less (+/-10%). Measurements are based on a size 9 US Men's and size 9 US Women's.

Participants will choose a pair of shoes from a selection of available colours. The shoes will fulfil the above criteria for minimalist shoes. As footwear manufacturers frequently change shoe models from season to season and year to year, we expect that shoes readily available at trial commencement may cease to be available during the course of the trial, or may be relaunched/rebranded with a different shoe name. In such instances, shoes will be replaced by a similar pair of commercially available shoes that fulfil the listed criteria.

The shoes will be provided at the University of Melbourne Human Movement Laboratory by one of the researchers experienced in the fitting shoes for participants in a randomized controlled trial. The laboratory session, which includes shoe fitting and biomechanical testing, will last approximately 90 minutes. Participants will be asked to wear their study shoes for all planned sport and exercise-based activities for the study duration of 3 months.

Participants will be provided with an information sheet regarding how to get used to wearing the shoes and will also complete a logbook for one week per month (the fourth week of the month). Both documents have been specifically designed for this study. The information sheet advises that participants should begin wearing their shoes for 1-2 hours on the first day during non-sporting activities, then gradually increase their wear time over subsequent days until the shoes are comfortable. At this point the participants can begin wearing their shoes during all planned sport and exercise-based activities. In the logbooks, participants will report how much they wore their shoes during all planned sport and exercise based activities for each day of that week. Additionally, a temperature microsensor will be embedded within the shoe to determine wear time. The data from the shoe temperature sensor will be collected at the end of the 3 month intervention period and provide accurate data on shoe wear time for each day
Intervention code [1] 324713 0
Treatment: Devices
Comparator / control treatment
The control treatment category is motion control shoes. The motion control shoes were selected from commercially available footwear, that fulfil previously published criteria for motion control shoes (Paterson et al, 2017,Osteoarthritis & Cartilage). These criteria are: 1) heel height of greater than 30mm; 2) shoe pitch of greater than 10mm; 3) presence of arch support or motion control; 4) have "rigid" sole rigidity (Barton et al. 2009, J Foot Ankle Res); and 5) weigh more than 300g (+/-10%).


Participants will choose a pair of shoes from a selection of available colours. The shoes will fulfil the above criteria for motion control shoes. As footwear manufacturers frequently change shoe models from season to season and year to year, we expect that shoes readily available at trial commencement may cease to be available during the course of the trial, or may be relaunched/rebranded with a different shoe name. In such instances, shoes will be replaced by a similar pair of commercially available shoes that fulfil the listed criteria.

The shoes will be provided at the University of Melbourne Human Movement Laboratory by one of the researchers experienced in the fitting shoes for participants in a randomized controlled trial. The laboratory session, which includes shoe fitting and biomechanical testing, will last approximately 90 minutes. Participants will be asked to wear their study shoes for all planned sport and exercise-based activities for the study duration of 3 months.

Participants will be provided with an information sheet regarding how to get used to wearing the shoes and will also complete a logbook for one week per month (the fourth week of the month). Both documents have been specifically designed for this study. The information sheet advises that participants should begin wearing their shoes for 1-2 hours on the first day during non-sporting activities, then gradually increase their wear time over subsequent days until the shoes are comfortable. At this point the participants can begin wearing their shoes during all planned sport and exercise-based activities. In the logbooks, participants will report how much they wore their shoes during planned sport and exercise based activities for each day of that week. Additionally, a temperature microsensor will be embedded within the shoe to determine wear time. The data from the shoe temperature sensor will be collected at the end of the 3 month intervention period and provide accurate data on shoe wear time for each day
Control group
Active

Outcomes
Primary outcome [1] 332904 0
Severity of worst knee pain

Participants will rate the severity of the worst knee pain experienced over the past week using an 11-point numerical rating scale (NRS). Ranges from 0 to 10; where 0=no pain and 10=worst pain possible.
Timepoint [1] 332904 0
Baseline, 3 months post-intervention commencement (primary timepoint)
Primary outcome [2] 332905 0
Self-reported physical function assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS)-child function in sport and play sub-scale.

Scored using 7 questions about function with sport and play activities in the last week, with 5 Likert response options ranging from "None" to "Extreme". Total score ranges from 0 to 100; lower scores indicate worse function in sport and play.
Timepoint [2] 332905 0
Baseline, 3 months post-intervention commencement (primary timepoint)
Secondary outcome [1] 415067 0
Global rating of change in pain.

Scored using a 7-point global rating of change in knee pain since baseline via a Likert scale with response options ranging from “much worse” to “much better” when compared to baseline. Participants that indicate they are “moderately better” or “much better” will be classified as improved. All other respondents will be classified as not improved. Number and proportion of participants classified as improved or not improved will be reported
Timepoint [1] 415067 0
3 months post-intervention commencement
Secondary outcome [2] 415068 0
KOOS-child pain sub-scale.

Scored using 8 questions about knee pain experienced in the last week, with Likert response options ranging from "None" to "Extreme". Total score ranges from 0 to 100; lower scores indicate worse knee pain.
Timepoint [2] 415068 0
Baseline, 3 months post-intervention commencement
Secondary outcome [3] 415069 0
KOOS-child symptoms sub-scale.

Scored using 7 questions about knee symptoms in the last week, with 5 Likert response options ranging from "Never/None" to "Always/Extreme". Total score ranges from 0 to 100; lower scores indicate worse knee symptoms.
Timepoint [3] 415069 0
Baseline, 3 months post-intervention commencement
Secondary outcome [4] 415070 0
KOOS-child difficulty with daily activities sub-scale.

Scored using 11 questions regarding difficulty with daily activities in the last week, with 5 Likert response options ranging from "None" to "Extreme". Total score ranges from 0 to 100; lower scores indicate greater difficulty with daily activities.
Timepoint [4] 415070 0
Baseline, 3 months post-intervention commencement
Secondary outcome [5] 415071 0
KOOS-child knee-related quality of life sub-scale.

Scored using 6 questions about knee-related quality of life experienced in the last week, with 5 Likert response options for each question ranging from "Never/None" to "Always/Extreme". Total score ranges from 0 to 100; lower scores indicate worse quality of life.
Timepoint [5] 415071 0
Baseline, 3 months post-intervention commencement
Secondary outcome [6] 415072 0
Kinesiophobia using the Tampa Scale of Kinesiophobia.

Scored using 17 questions assessing fear of movement, fear of physical activity and fear avoidance, with 4 Likert responses range from "Strongly Disagree" to "Strongly Agree". Total score ranges from 17 (no kinesiophobia) to 68 (severe kinesiophobia).
Timepoint [6] 415072 0
Baseline, 3 months post-intervention commencement
Secondary outcome [7] 415073 0
Proportion of participants achieving a clinically-relevant improvement in knee pain and function.

Classified based on individual change in (i) knee pain and (ii) function (primary outcomes), where anyone achieving a pain reduction greater than or equal to the minimal clinically important difference (MCID) of 1.5 NRS units, or 10 out of 100 on the KOOS-child function in sport and play sub-scale, is classified as achieving a clinically-relevant pain or function reduction. Number and proportion of participants achieving, and not achieving, a clinically-relevant reduction in knee pain and function will be reported.
Timepoint [7] 415073 0
Baseline, 3 months post-intervention commencement
Secondary outcome [8] 415401 0
Physical Activity Questionnaire for Adolescents.

Contains 8 questions about how many days and hours per week adolescents have performed physical activities over the prior 7 days, scored using different 5-point scales. Final score is the mean of each score from the 8 items. Score ranges from 1 to 5, with higher scores indicating a higher level of activity.
Timepoint [8] 415401 0
Baseline and 3 months post-intervention commencement
Secondary outcome [9] 415402 0
Shoe wear time.

An Orthotimer temperature microsensor will be positioned within the shoe to detect when the shoe is being worn. The average daily shoe wear will be reported for months 1, 2 and 3, as well as for the entire 3-month intervention period.
Timepoint [9] 415402 0
Months 1, 2, and 3 post-intervention commencement
Secondary outcome [10] 415403 0
Adherence: self-rated adherence with footwear.

Participants will self-report how much of the time they wore their study shoes during planned sport and exercise-based activities during the last week of each month following the intervention commencement. They will do so using a 5-point Likert scale, with response options ranging from “Not at all” to “All of the time”. Participants that indicate they wore the study shoes “All of the time” or “Most of the time” during planned sport and exercise-based activities will be classified as adherent. All other respondents will be classified as not adherent. Number and proportion of participants classified as adherent or not adherent will be reported
Timepoint [10] 415403 0
Months 1, 2, and 3 post-intervention commencement
Secondary outcome [11] 415404 0
Co-intervention use.

Participants will complete a custom-developed table to indicate the use of a range of medications and other co-interventions over the prior 3 months. Participants who indicate they have used a medication/supplement at least once per week over the past 3 months will be reported as a user of the relevant medication. Participants who have used a co-intervention at least once in the past 3 months will be reported as a co-intervention user. Number and proportion of participants using the medication and/or cointervention will be reported.
Timepoint [11] 415404 0
Baseline and 3 months post-intervention commencement
Secondary outcome [12] 415405 0
Adverse events.

Adverse events will be defined as any problem experienced in the study knee or elsewhere in the body deemed by the participant to be a result of participating in the trial AND at least one of i) caused increased pain and/or disability for two days or more ii) resulted in the participant seeking treatment from a health professional, and/or iii) caused the participant to miss one or more planned sports or activity session. These will be self-reported by participants or parents/guardians using a custom-developed table. Nature, number, and proportions of participants experiencing adverse events will be reported.
Timepoint [12] 415405 0
Self-reported by participants during the 3-month intervention at the time of the event. Adverse events are also participant reported at 3 months.
Secondary outcome [13] 415406 0
Number of participants who stopped wearing the study shoes.

Participants will indicate whether they stopped wearing the study shoes during the 3 months on a categorical scale (Yes or No). Participants who score Yes will describe when and why they ceased wearing their allocated shoes, and this will be reported descriptively.
Timepoint [13] 415406 0
3 months post-intervention commencement
Secondary outcome [14] 415407 0
Comfort.

Participants will rate their level of comfort with wearing the shoe during sport/exercise using an 11-point NRS (where 0=extremely uncomfortable and 10=extremely comfortable). Ranges from 0 to 10; higher scores indicate greater shoe comfort.
Timepoint [14] 415407 0
3 months post-intervention commencement
Secondary outcome [15] 415408 0
Current planned sport and exercise-based activity participation.

Participants will report what sport and exercise-based activities they participate in, and how long (in hours) they participate in each activity on average per week over the last month, by selecting from a list of predetermined sports. The list will include an “other (please specify)” option. The number of participants and average weekly duration of participation for each sport will be reported.
Timepoint [15] 415408 0
Baseline, 1, 2, and 3-months post-intervention commencement

Eligibility
Key inclusion criteria
i) adolescents aged 12 to 19 years,
ii) participate in planned sport and exercise-based activities that load the patellofemoral joint for at least 60 minutes per week,
iii) participate in planned sport and exercise-based activities that load the patellofemoral joint and that cause knee pain either during or after that is greater than or equal to 3 on an 11-point numerical rating scale (0 no pain; 10 = worst pain imaginable),
iv) report pain in or around the front of the knee that is aggravated by at least one activity that loads the patellofemoral joint during weightbearing, including squatting, stair climbing, running, hopping, jumping,
v) have a history of knee pain for greater than or equal to 2 months.
Minimum age
12 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) attending primary school,
ii) a history of patellar dislocation,
iii) traumatic onset of knee symptoms,
iv) recent knee surgery in the past 6 months or planned surgery in next 3 months,
v) unable to wear study footwear during sport and exercise activities,
vi) current use of shoe orthoses,
vii) diagnosed in the past 12 months by a health professional as having a knee condition other than patellofemoral pain,
viii) self-report other muscle or joint condition anywhere in the body which is worse than study knee pain,
ix) self-report any systemic or inflammatory joint disease (e.g., juvenile idiopathic arthritis),
x) any neurological condition affecting the spine or either lower limb, and
xi) inability to understand written/spoken English.
xii) unable to commit to study requirements (eg wearing shoes, attending appointments, completing outcomes, do not have foot size in the range of 7 to 13 US for men, and 6 to 11US for women).

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)
The person who will determine if a potential participant is eligible for inclusion in the trial will be unaware, when this decision is made, to which group the participant will be allocated. The randomisation schedule will be concealed in a password protected computer database. A member of the research team will maintain and access the schedule and reveal allocation to the Trial Coordinator as each participant requires randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be prepared by the biostatistician (permuted random block sizes). The schedule will be stored on a password-protected website (REDCap) maintained by a researcher not involved in either participant recruitment or administration of primary/secondary outcome measures. Group allocation will be revealed by this same researcher after baseline primary/secondary outcomes have been completed.
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
Total sample sizes of 126 (63 per arm) and 48 (24 per arm) are required to detect clinically meaningful between-group differences of 1.5 units (out of 10) for the NRS pain and 10 (out of 100) for function using the KOOS-child function in sport and play sub-scale respectively at 3-months, with 90% power and alpha=0.05 (split between the two primary outcomes). This assumes equal standard deviations of 23.8 and 15 for each outcome at 3-months respectively for each group, and no correlation (intraclass correlation coefficient=0) between baseline and 3-months given the lack of footwear RCT data upon which to base assumptions. Allowing for a conservative 20% attrition, we will recruit 79 people per arm (n=158).

Data will be managed via REDCap®. All analyses will be performed by CI Ling under CI Lamb’s supervision and will be described a priori in a Statistical Analysis Plan that will be developed while blinded to group allocation and published on our website before analyses commence. Main comparative analyses between groups will be performed using intention-to-treat including all randomised participants according to their allocated study arm. For the primary hypothesis, differences in mean change in pain and function (baseline minus follow-up) will be compared between groups using linear regression modelling adjusted for baseline values. Multiple imputation will be used to account for missing data if required (i.e., if >5% missing values for either outcome). We will consider minimalist shoes to be more effective if either of the primary outcomes shows benefits. Similar analyses will be conducted for continuous secondary outcomes. The proportion of participants in each group that show an improvement that reaches or exceeds the MCID in change in NRS knee pain (1.5 units) and the KOOS-child function in sport and play sub-scale (10 out of 100) will be calculated. For these and other binary outcomes, groups will be compared using risk ratios and risk differences, using logistic regression models. The number of participants who experience an adverse event will be compared between groups using Poisson regression. A sensitivity analysis will estimate treatment effects assuming full adherence, using an instrumental variables approach. Standard diagnostic plots will be used to check model assumptions.

To assess whether the effect of the intervention on the primary outcome of NRS pain is moderated by the pre-specified moderator of foot posture, an interaction term between randomised group and this variable will be included in regression models for the primary outcome at 3 months. The rationale for the a priori choice of treatment effect modifiers is as follows:

• Foot posture- we hypothesise that decreases in knee pain with minimalist shoes (relative to motion control) will be lesser in people with a more pronated foot posture, given shoes with arch supporting insoles have been found to significantly reduce peak patellofemoral joint contact forces in people with a pronated foot.
• Participation in jumping based sports- we hypothesise that decreases in knee pain with minimalist shoes (relative to motion control) will be greater in adolescents who participate in jumping-based sports because there are higher patellofemoral joint loads in these activities, hence there is greater scope for improvement with minimalist shoes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2023
Actual
22/03/2023
Date of last participant enrolment
Anticipated
1/06/2026
Actual
Date of last data collection
Anticipated
1/09/2026
Actual
Sample size
Target
158
Accrual to date
41
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 312508 0
Government body
Name [1] 312508 0
Australian Government Department of Health: Medical Research Future Fund
Country [1] 312508 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Office of Research, Ethics and Integrity
Research, Innovation & Commercialisation
Level 5, Alan Gilbert Building, 161 Barry Street, Carlton
University of Melbourne VIC 3010
Country
Australia
Secondary sponsor category [1] 314103 0
None
Name [1] 314103 0
Address [1] 314103 0
Country [1] 314103 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311844 0
University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 311844 0
Ethics committee country [1] 311844 0
Australia
Date submitted for ethics approval [1] 311844 0
07/11/2022
Approval date [1] 311844 0
14/12/2022
Ethics approval number [1] 311844 0

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

Contacts
Principal investigator
Name 122570 0
A/Prof Kade Paterson
Address 122570 0
Centre for Health Exercise and Sports Medicine
Department of Physiotherapy
Level 7, Alan Gilbert Building, 161 Barry Street, Carlton
The University of Melbourne, VIC, 3010
Country 122570 0
Australia
Phone 122570 0
+61 3 8344 0425
Fax 122570 0
Email 122570 0
[email protected]
Contact person for public queries
Name 122571 0
Sam Shearer
Address 122571 0
Centre for Health Exercise and Sports Medicine
Department of Physiotherapy
Level 7, Alan Gilbert Building, 161 Barry Street, Carlton
The University of Melbourne VIC 3010
Country 122571 0
Australia
Phone 122571 0
+61 3 8344 1294
Fax 122571 0
Email 122571 0
[email protected]
Contact person for scientific queries
Name 122572 0
Kade Paterson
Address 122572 0
Centre for Health Exercise and Sports Medicine
Department of Physiotherapy
Level 7, Alan Gilbert Building, 161 Barry Street, Carlton
The University of Melbourne VIC 3010
Country 122572 0
Australia
Phone 122572 0
+61 3 8344 0425
Fax 122572 0
Email 122572 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified individual participant data of published results only.
When will data be available (start and end dates)?
Immediately following publication to 15 years following publication.
Available to whom?
Available to researchers by request on a case-by-case basis at the discretion of the principal researcher.
Available for what types of analyses?
Meta analyses.
How or where can data be obtained?
From the principal researcher (email: [email protected]), with the appropriate Data Sharing Agreements as approved by the sponsor (the University of Melbourne).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17449Study protocol  [email protected] Upon direct request to the principal researcher
17450Statistical analysis plan  [email protected] Upon direct request to the principal researcher



Results publications and other study-related documents

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