Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000851763
Ethics application status
Approved
Date submitted
29/07/2013
Date registered
2/08/2013
Date last updated
5/04/2024
Date data sharing statement initially provided
5/04/2024
Date results information initially provided
5/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Modified SHoes for osteoARthritis of the Knee: the SHARK study
Scientific title
The effect of modified shoes on pain and function in people with osteoarthritis of the knee (SHARK study): a randomized controlled trial
Secondary ID [1] 282827 0
Nil
Universal Trial Number (UTN)
U1111-1145-8314
Trial acronym
SHARK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis 289610 0
Condition category
Condition code
Musculoskeletal 289949 289949 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: modified walking shoes (that are denser/more rigid on the outside (laterally) compared to the inside (medially)) designed to unload the knee joint of people with knee osteoarthritis- Gel Melbourne OA shoes (Asics). Participants will be instructed to wear their allocated shoes every day for six months, for at least 4 hours per day. Shoe wear will be monitored by use of log-books and pedometers.
Intervention code [1] 287514 0
Treatment: Devices
Intervention code [2] 287588 0
Rehabilitation
Comparator / control treatment
Control condition: non-modified walking shoes- Gel Odyssey shoes (Asics). Participants will be instructed to wear their allocated shoes every day for six months, for at least 4 hours per day. Shoe wear will be monitored by use of log-books and pedometers.
Control group
Active

Outcomes
Primary outcome [1] 290000 0
Pain assessed by 11-point numeric rating scale
Timepoint [1] 290000 0
Baseline and 6 months
Primary outcome [2] 290001 0
Self-reported physical function assessed by Western Ontario & McMaster Osteoarthritis Index (WOMAC) physical function sub-scale
Timepoint [2] 290001 0
Baseline and 6 months
Secondary outcome [1] 303757 0
Participant-perceived response to treatment (changes in pain and physical function) rated on a 7-point scale
Timepoint [1] 303757 0
3 months and 6 months
Secondary outcome [2] 303758 0
Health-related quality of life assessed using the Assessment of Quality of Life instrument (AQoL)
Timepoint [2] 303758 0
Baseline and 6 months
Secondary outcome [3] 303891 0
Self-reported pain assessed by Western Ontario & McMaster Osteoarthritis Index (WOMAC) pain sub-scale
Timepoint [3] 303891 0
Baseline, 3 months and 6 months
Secondary outcome [4] 303892 0
Self-reported knee stiffness assessed by Western Ontario & McMaster Osteoarthritis Index (WOMAC) stiffness sub-scale
Timepoint [4] 303892 0
Baseline, 3 months and and 6 months
Secondary outcome [5] 303893 0
Physical activity measured by the Physical Activity Scale for the Elderly (PASE)
Timepoint [5] 303893 0
Baseline and 6 months
Secondary outcome [6] 303894 0
Adverse events (such as foot pain, increased knee pain etc), co-interventions (such as analgesics, anti-inflammatories, physiotherapy etc) and shoe wear self-reported by participants in log books
Timepoint [6] 303894 0
Baseline, monthly and at 6 months.
Secondary outcome [7] 303895 0
Proportion of daily steps taken wearing allocated shoes as measured by waist and shoe pedometers (over a 7-day period).
Timepoint [7] 303895 0
Months 2 and 5.
Secondary outcome [8] 303896 0
Measures of foot posture, mobility and anthropometry (eg Foot Posture Index, navicular drift and drop)
Timepoint [8] 303896 0
Baseline
Secondary outcome [9] 303897 0
Lower limb joint kinetics and kinematics measured via 3-dimensional gait analysis.
Timepoint [9] 303897 0
Baseline and 6 months
Secondary outcome [10] 303898 0
Knee pain measured via the the Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP) tool
Timepoint [10] 303898 0
Baseline and 6 months
Secondary outcome [11] 303899 0
Prevalence of neuropathic pain using the painDETECT tool.
Timepoint [11] 303899 0
Baseline
Secondary outcome [12] 303958 0
Self-reported physical function assessed by Western Ontario & McMaster Osteoarthritis Index (WOMAC) physical function sub-scale
Timepoint [12] 303958 0
3 months

Eligibility
Key inclusion criteria
Aged>50;
Knee pain on most days of the last month;
Kellgren & Lawrence Grade 2 or above radiographic changes
Presence of medial osteoarthritis on x-ray (grade 1 medial osteophytes AND grade 1 medial joint space narrowing, as defined by a standard radiographic atlas);
Minimum average knee pain score of 4 on an 11-point numerical rating scale
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Predominant lateral tibiofemoral osteoarthritis on x-ray (lateral osteophytes (joint space narrowing) greater than medial);
Intra-articular corticosteroid injection or knee surgery to either knee within past 3 months;
Systemic arthritic conditions;
History of knee joint replacement or high tibial osteotomy or plan for surgery to either knee in next 6 months;
Other muscular, joint or neurological condition affecting lower limb function;
Current or previous 6 months use of shoe insert, knee or ankle brace or customised shoes prescribed by a health professional;
Unable to walk unaided;
Body mass index> 36 kg/m2 (due to difficulties in biomechanical gait analysis);
Ankle/foot pathology/pain on either side

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. Allocation will be concealed in sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be prepared by the study biostatistician using random permuted blocks, and stratified by Kellgren & Lawrence grading of radiographic severity.
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
Main comparative analyses between groups will be performed using intention-to-treat. For continuous outcomes, differences in mean change (baseline minus follow-up) will be compared between groups using linear regression modelling adjusted for baseline values of the outcome.

Sample size calculations have been based on minimum clinically important differences in pain (numerical rating scale) and physical function (WOMAC). The sample size of 164 people provides 90% power to detect minimum clinically important differences in pain and function between treatment groups and allows for a 20% attrition rate.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/08/2013
Actual
26/08/2013
Date of last participant enrolment
Anticipated
31/12/2015
Actual
14/05/2015
Date of last data collection
Anticipated
Actual
24/11/2015
Sample size
Target
164
Accrual to date
Final
164
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 7189 0
3010 - University Of Melbourne

Funding & Sponsors
Funding source category [1] 287611 0
Government body
Name [1] 287611 0
National Health and Medical Research Council
Country [1] 287611 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
The University of Melbourne
VIC 3010
Country
Australia
Secondary sponsor category [1] 286385 0
None
Name [1] 286385 0
Address [1] 286385 0
Country [1] 286385 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289582 0
University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 289582 0
Melbourne Research
The University of Melbourne
Level 5, Alan Gilbert Building
VIC 3010
Ethics committee country [1] 289582 0
Australia
Date submitted for ethics approval [1] 289582 0
Approval date [1] 289582 0
20/02/2013
Ethics approval number [1] 289582 0
1239045

Summary
Brief summary
Knee osteoarthritis (OA) affects many older people and is a major public health problem. Afflicted individuals suffer from knee pain and physical dysfunction that impacts dramatically on quality of life. Osteoarthritis has no cure and often gets worse over time. Non-toxic treatments that reduce symptoms and assist patient self-management over the long-term are needed. Increased joint loading (force across the knee) is central to pain development and increased risk of disease progression in people with knee OA. The type of shoes a person wears can increase or decrease their knee load depending on the shoe design features. This randomised controlled trial will test the efficacy of modified shoes (designed to unload the knee joint) for reducing symptoms and improving physical function in people with knee OA.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41430 0
A/Prof Rana Hinman
Address 41430 0
Physiotherapy, Melbourne School of Health Sciences
The University of Melbourne
Alan Gilbert Building, 161 Barry St
Carlton, Vic, 3053
Country 41430 0
Australia
Phone 41430 0
+61 3 8344 3223
Fax 41430 0
Email 41430 0
ranash@unimelb.edu.au
Contact person for public queries
Name 41431 0
Ms Penelope Campbell
Address 41431 0
Level 7, CHESM
The University of Melbourne
Alan Gilbert Building, 161 Barry St
Carlton, Vic, 3053
Country 41431 0
Australia
Phone 41431 0
+61 3 9035 5702
Fax 41431 0
Email 41431 0
penelope.campbell@unimelb.edu.au
Contact person for scientific queries
Name 41432 0
A/Prof Rana Hinman
Address 41432 0
Physiotherapy, Melbourne School of Health Sciences
The University of Melbourne
Alan Gilbert Building, 161 Barry St
Carlton, Vic, 3053
Country 41432 0
Australia
Phone 41432 0
+61 3 8344 3223
Fax 41432 0
Email 41432 0
ranash@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All data in the published results paper will be made available (Ann Intern Med. 2016;165:381-389. doi:10.7326/M16-0453).
When will data be available (start and end dates)?
12/06/2016 - 12/06/2031 (a period of 15 years from publication)
Available to whom?
Data will be made available to researchers as required for specific, approved analyses. Data will be provided from locked, cleaned, and de- identified study database. Requests will be reviewed by the Principal Investigator prior to approval.
Available for what types of analyses?
The investigators endorse the concept of data sharing to advance medical science. All requests for data sharing will be reviewed by the Principal Investigator to ensure no conflict with any planned sub analyses and to ensure that the data are shared in an ethical and protected manner.

Analyses aimed to improve treatment of knee osteoarthritis for non-commercial purposes are eligible.
How or where can data be obtained?
By emailing the Principal Investigator (ranash@unimelb.edu.au). Data will be made available after review and approval by the Principal Investigator. Before any analysis, a signed Confidentiality Agreement and/or Data Sharing Agreement is required.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22106Data dictionary    The Data Dictionary will be supplied with the de-i... [More Details]



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Ann Intern Med. 2016;165:381-389. doi:10.7326/M16-... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseUnloading shoes for self-management of knee osteoarthritis a randomized trial.2016https://dx.doi.org/10.7326/M16-0453
EmbaseAssociations between changes in knee pain location and clinical symptoms in people with medial knee osteoarthritis using footwear for self-management: an exploratory study.2017https://dx.doi.org/10.1016/j.joca.2017.03.003
N.B. These documents automatically identified may not have been verified by the study sponsor.