ANZCTR - Registration

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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 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]

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

Condition category

Condition code

Musculoskeletal

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]

Treatment: Devices

Intervention code [2]

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]

Pain assessed by 11-point numeric rating scale

Timepoint [1]

Baseline and 6 months

Primary outcome [2]

Self-reported physical function assessed by Western Ontario & McMaster Osteoarthritis Index (WOMAC) physical function sub-scale

Timepoint [2]

Baseline and 6 months

Secondary outcome [1]

Participant-perceived response to treatment (changes in pain and physical function) rated on a 7-point scale

Timepoint [1]

3 months and 6 months

Secondary outcome [2]

Health-related quality of life assessed using the Assessment of Quality of Life instrument (AQoL)

Timepoint [2]

Baseline and 6 months

Secondary outcome [3]

Self-reported pain assessed by Western Ontario & McMaster Osteoarthritis Index (WOMAC) pain sub-scale

Timepoint [3]

Baseline, 3 months and 6 months

Secondary outcome [4]

Self-reported knee stiffness assessed by Western Ontario & McMaster Osteoarthritis Index (WOMAC) stiffness sub-scale

Timepoint [4]

Baseline, 3 months and and 6 months

Secondary outcome [5]

Physical activity measured by the Physical Activity Scale for the Elderly (PASE)

Timepoint [5]

Baseline and 6 months

Secondary outcome [6]

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]

Baseline, monthly and at 6 months.

Secondary outcome [7]

Proportion of daily steps taken wearing allocated shoes as measured by waist and shoe pedometers (over a 7-day period).

Timepoint [7]

Months 2 and 5.

Secondary outcome [8]

Measures of foot posture, mobility and anthropometry (eg Foot Posture Index, navicular drift and drop)

Timepoint [8]

Baseline

Secondary outcome [9]

Lower limb joint kinetics and kinematics measured via 3-dimensional gait analysis.

Timepoint [9]

Baseline and 6 months

Secondary outcome [10]

Knee pain measured via the the Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP) tool

Timepoint [10]

Baseline and 6 months

Secondary outcome [11]

Prevalence of neuropathic pain using the painDETECT tool.

Timepoint [11]

Baseline

Secondary outcome [12]

Self-reported physical function assessed by Western Ontario & McMaster Osteoarthritis Index (WOMAC) physical function sub-scale

Timepoint [12]

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?

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]

3010 - University Of Melbourne

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

National Health and Medical Research Council GPO Box 1421 Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

The University of Melbourne

Address

The University of Melbourne
VIC 3010

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Melbourne Human Research Ethics Committee

Ethics committee address [1]

Melbourne Research
The University of Melbourne
Level 5, Alan Gilbert Building
VIC 3010

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

20/02/2013

Ethics approval number [1]

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

A/Prof Rana Hinman

Address

Physiotherapy, Melbourne School of Health Sciences The University of Melbourne Alan Gilbert Building, 161 Barry St Carlton, Vic, 3053

Country

Australia

Phone

+61 3 8344 3223

Fax

[email protected]

Contact person for public queries

Name

Penelope Campbell

Address

Level 7, CHESM The University of Melbourne Alan Gilbert Building, 161 Barry St Carlton, Vic, 3053

Country

Australia

Phone

+61 3 9035 5702

Fax

[email protected]

Contact person for scientific queries

Name

Rana Hinman

Address

Physiotherapy, Melbourne School of Health Sciences The University of Melbourne Alan Gilbert Building, 161 Barry St Carlton, Vic, 3053

Country

Australia

Phone

+61 3 8344 3223

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• 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.

Conditions for requesting access:
• -

What individual participant data might 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).

What types of analyses could be done with individual participant data?

• 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.

When can requests for individual participant data be made (start and end dates)?

From:
12/06/2016

To:
12/06/2031 (a period of 15 years from publication)

Where can requests to access individual participant data be made, or data be obtained directly?

• By emailing the Principal Investigator ([email protected]). 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.

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Type	Citation	Link	Email	Other Details	Attachment
Data dictionary				The Data Dictionary will be supplied with the de-i... [More Details]

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		Ann Intern Med. 2016;165:381-389. doi:10.7326/M16-... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Unloading shoes for self-management of knee osteoarthritis a randomized trial.	2016	https://dx.doi.org/10.7326/M16-0453
Embase	Associations between changes in knee pain location and clinical symptoms in people with medial knee osteoarthritis using footwear for self-management: an exploratory study.	2017	https://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.

Trial Review

Documents added manually

Documents added automatically