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Trial registered on ANZCTR


Registration number
ACTRN12619000957190
Ethics application status
Approved
Date submitted
24/06/2019
Date registered
8/07/2019
Date last updated
15/11/2021
Date data sharing statement initially provided
8/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
HAPPi Kneecaps! A feasibility trial of shoe inserts for adolescents with patellofemoral pain
Scientific title
HAPPi Kneecaps! A feasibility trial of shoe inserts for adolescents with patellofemoral pain
Secondary ID [1] 298455 0
None
Universal Trial Number (UTN)
Trial acronym
HAPPi Kneecaps! (sHoe inserts for Adolescents with Patellofemoral PaIn)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patellofemoral pain 313198 0
Condition category
Condition code
Musculoskeletal 311658 311658 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 311659 311659 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Contoured inserts:
Participants will receive commercially available prefabricated foot orthoses (Vasyli Medical, Labrador, Australia). These are manufactured from ethylene-vinyl acetate (EVA) of high, medium and low density, and have an inbuilt arch support and varus wedging. A variety of lengths and shapes will be utilised to fit the shape of each participant’s footwear appropriately.

Each participant will attend a private physiotherapy clinic for fitting of the inserts. Study practitioners will be trained in fitting procedures, and will follow our published algorithm (Collins NJ et al, 2019, BMJ Open, 9(4):e025315). Practitioners will ensure that the inserts are comfortable, and can enhance this by adding wedges or gently heat molding the device. Participants will receive up to four pairs of inserts fit to their daily shoes (e.g. school shoes, sports shoes, casual shoes), which can be transferred to other footwear as required. Participants will attend up to three appointments with the physiotherapist to ensure adequate comfort of the inserts, and will receive written instructions for using and adapting to the inserts. Participants will be asked to wear their inserts as much as possible during their waking hours, and record their daily hours of wear in a logbook. Study practitioners will record the number of appointments attended.
Intervention code [1] 314702 0
Treatment: Devices
Comparator / control treatment
Flat inserts:
Participants will receive flat inserts made of high density EVA (shore A 75 degrees) with a uniform thickness (3mm) and no inbuilt arch or wedging. The flat inserts will have an identical covering fabric as the contoured inserts. Participants will receive up to four pairs of inserts fit to their daily shoes (e.g. school shoes, sports shoes, casual shoes), which can be transferred to other footwear as required. Participants will attend up to three appointments with the physiotherapist to ensure adequate comfort of the inserts, and will receive written instructions for using and adapting to the inserts. Participants will be asked to wear their inserts as much as possible during their waking hours, and record their daily hours of wear in a logbook. Study practitioners will record the number of appointments attended.
Control group
Placebo

Outcomes
Primary outcome [1] 320365 0
Feasibility is a composite outcome, and will be assessed by evaluating:
(i) willingness of participants to enrol (from recruitment database);
(ii) number of eligible participants (from recruitment database);
(iii) recruitment rate (from recruitment database);
(iv) adherence with allocated intervention and log book completion (from study practitioner notes and participant logbooks);
(v) adverse effects (from study practitioner notes and participant logbooks);
(vi) success of blinding (from study exit questionnaire); and
(vii) drop-out rate (from trial database).

Participants will be asked to complete daily log-books (electronic or paper), assisted by their parent/guardian as required and checked for completion. Participants will record their physical activity, footwear worn, insert wear time, and any adverse effects. Study practitioners will record attendance, prescription notes and adverse effects during fitting and follow-up.
Timepoint [1] 320365 0
Assessed at completion of data collection
Primary outcome [2] 320366 0
Credibility of treatment will be evaluated using the Credibility and Expectancy Questionnaire.
Timepoint [2] 320366 0
Baseline, 2 weeks
Secondary outcome [1] 371363 0
Pain severity will be measured using a series of 100mm visual analogue scales (where 0mm = no pain and 100mm = worst pain imaginable). Participants will be asked to rate their usual and worst pain in the preceding week, as well as pain with a self-nominated aggravating activity.
Timepoint [1] 371363 0
Baseline, 6 weeks, 3 months
Secondary outcome [2] 371364 0
Participants will complete the Child Version of the Knee injury and Osteoarthritis Outcome Score (KOOS-Child). This consists of five subscales: symptoms, pain, function in activities of daily living, function in sport/ recreation, and knee related quality of life.
Timepoint [2] 371364 0
Baseline, 6 weeks, 3 months
Secondary outcome [3] 371365 0
Participants will complete the KOOS patellofemoral subscale (KOOS-PF).
Timepoint [3] 371365 0
Baseline, 6 weeks, 3 months
Secondary outcome [4] 371820 0
Global rating of change (GROC) will be measured on an 7-point Likert scale (‘completely recovered’, ‘strongly recovered’, ‘slightly recovered’, ‘same’, ‘slightly worse’, ‘much worse’ and ‘worse than ever’).
Timepoint [4] 371820 0
Baseline, 6 weeks, 3 months
Secondary outcome [5] 371821 0
Patient Acceptable Symptom State
Timepoint [5] 371821 0
Baseline, 6 weeks, 3 months
Secondary outcome [6] 371822 0
The Anterior Knee Pain Scale will be used to measure symptoms and function.
Timepoint [6] 371822 0
Baseline, 6 weeks, 3 months
Secondary outcome [7] 371823 0
Quality of life will be measured using the Youth Quality of Life Instrument - Short Form (YQOL-SF).
Timepoint [7] 371823 0
Baseline, 6 weeks, 3 months
Secondary outcome [8] 371824 0
Health-related quality of life will be measured using EQ-5D-5L.
Timepoint [8] 371824 0
Baseline, 6 weeks, 3 months
Secondary outcome [9] 372240 0
Use of co-interventions: Participants will be asked to keep a daily record of any other interventions utilised throughout the study (outside of their allocated intervention) (e.g. pain medication, physiotherapy).
Timepoint [9] 372240 0
Daily for 3 months

Eligibility
Key inclusion criteria
(i) Aged 12-18 years; (ii) anterior knee pain of non-traumatic origin that is rated at least 3 on an 11-point numerical rating scale (0=no pain, 10=maximal pain); (iii) knee pain aggravated by activities that load the patellofemoral joint (e.g. squatting, stair climbing); (iv) knee pain present at some time during most weeks; and (v) knee pain of at least 2 months duration.
Minimum age
12 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) Concomitant pain at sites other than the anterior knee; (ii) history of knee, hip or spine surgery, or other suspected knee joint pathology (e.g. Osgood Schlatter’s Disease); (iii) planned lower limb surgery (e.g. arthroscopy); (iv) recent treatment for PFP (knee injections or physiotherapy within the previous 3 months; foot orthoses within the previous 12 months); and (v) any foot condition precluding the use of foot orthoses.

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)
Allocation will be concealed. The assessor who determines eligibility will be unaware of which group the participant will be allocated to, and will remain blinded to group allocation throughout the study period. Allocation will be determined by an independent investigator, who will hold the allocation sequence and communicate each participant's group allocation to an unblinded assessor.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This study will use simple randomisation, with the sequence generated by computer software.
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
Safety/efficacy
Statistical methods / analysis
Formal sample size calculations are not applicable for feasibility studies. A sample of 40 participants ensures feasibility of recruitment and follow-up, while allowing for observation of sample variability, potential adverse effects of the intervention, and dropouts.

Descriptive statistics will be used for the primary outcomes of feasibility. Between-group effect sizes (with 95% confidence intervals) will be calculated for change in secondary outcome measures, and used to calculate sample size estimates. Analyses will be conducted by an investigator who is blinded to group allocation.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Recruitment was ceased in March 2020 (at n=36) due to COVID-19 restrictions.
Date of first participant enrolment
Anticipated
8/07/2019
Actual
30/08/2019
Date of last participant enrolment
Anticipated
Actual
24/02/2020
Date of last data collection
Anticipated
Actual
9/06/2020
Sample size
Target
40
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 26742 0
4072 - University Of Queensland

Funding & Sponsors
Funding source category [1] 303001 0
Charities/Societies/Foundations
Name [1] 303001 0
Arthritis Australia
Country [1] 303001 0
Australia
Primary sponsor type
Individual
Name
Dr Natalie Collins
Address
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 302973 0
Individual
Name [1] 302973 0
Professor Kay Crossley
Address [1] 302973 0
School of Allied Health
College of Science, Health and Engineering
La Trobe University
Bundoora VIC 3086
Country [1] 302973 0
Australia
Secondary sponsor category [2] 302974 0
Individual
Name [2] 302974 0
Assoc Prof Steve Kamper
Address [2] 302974 0
School of Public Health
The University of Sydney
NSW 2006
Country [2] 302974 0
Australia
Secondary sponsor category [3] 302975 0
Individual
Name [3] 302975 0
Assoc Prof Marienke van Middelkoop
Address [3] 302975 0
Department of General Practice
Erasmus MC
Rotterdam, 3000CA, The Netherlands
Country [3] 302975 0
Netherlands

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303550 0
University of Queensland Human Research Ethics Committee
Ethics committee address [1] 303550 0
The University of Queensland
St Lucia, QLD, 4072
Ethics committee country [1] 303550 0
Australia
Date submitted for ethics approval [1] 303550 0
Approval date [1] 303550 0
06/04/2018
Ethics approval number [1] 303550 0
2018000159

Summary
Brief summary
One-quarter of adolescents live with regular, debilitating kneecap pain. This causes substantial pain and disability, and reduces quality of life. Kneecap pain in adolescents is not a self-limiting condition – up to 95% continue to have pain after two to eight years. This can set the scene for a lifetime of knee pain and associated health implications, with many adolescents reducing or withdrawing from sport and physical activity. The problem is the lack of evidence and clinical guidelines for effective treatments for adolescents with kneecap pain. Best-evidence treatments for adults with kneecap pain, such as exercise, are not as effective for adolescents. This may be because adolescents simply do not do their prescribed exercises. 'Off-the-shelf' shoe inserts may be the solution. These are simple, accessible, low-cost devices that are easy for adolescents to wear in their regular footwear, such as school and sports shoes. The HAPPi Kneecaps! Trial will determine the feasibility of conducting a full-scale randomised clinical trial investigating shoe inserts for adolescents with kneecap pain. Secondary outcomes will explore whether shoe inserts can improve pain, function and quality of life in this population. Findings will inform future large-scale clinical trials, with the potential to advise clinical practice guidelines providing adolescents with effective, evidence-based options for managing their kneecap pain. This study is an essential first step in identifying effective interventions for adolescents with kneecap pain, with the potential to change the persistent, chronic nature of kneecap pain at its earliest onset.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94054 0
Dr Natalie Collins
Address 94054 0
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia, QLD, 4072
Country 94054 0
Australia
Phone 94054 0
+61 7 3365 2124
Fax 94054 0
Email 94054 0
[email protected]
Contact person for public queries
Name 94055 0
Isobel O'Sullivan
Address 94055 0
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia, QLD, 4072
Country 94055 0
Australia
Phone 94055 0
+61 7 3365 2124
Fax 94055 0
Email 94055 0
[email protected]
Contact person for scientific queries
Name 94056 0
Natalie Collins
Address 94056 0
School of Health and Rehabilitation Sciences
The University of Queensland
St Lucia, QLD, 4072
Country 94056 0
Australia
Phone 94056 0
+61 7 3365 2124
Fax 94056 0
Email 94056 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?
De-identified individual participant data collected during the trial
When will data be available (start and end dates)?
After publication, no end date determined
Available to whom?
Access to this data will be determined on a case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access to the data will be subject to approvals by Principal Investigator (email: [email protected]), with a requirement to sign a data access agreement.


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
EmbaseHAPPi Kneecaps! A double-blind, randomised, parallel group superiority trial investigating the effects of sHoe inserts for adolescents with patellofemoral PaIn: phase II feasibility study.2021https://dx.doi.org/10.1186/s13047-021-00498-0
EmbaseAdolescent perspectives on participating in a feasibility trial investigating shoe inserts for patellofemoral pain.2022https://dx.doi.org/10.1186/s13047-022-00537-4
N.B. These documents automatically identified may not have been verified by the study sponsor.