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Trial registered on ANZCTR


Registration number
ACTRN12620000276954p
Ethics application status
Not yet submitted
Date submitted
19/02/2020
Date registered
3/03/2020
Date last updated
3/03/2020
Date data sharing statement initially provided
3/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Rocker sole footwear for the treatment of painful midfoot osteoarthritis: a pilot randomised controlled trial
Scientific title
Rocker sole footwear for the treatment of painful midfoot osteoarthritis: a pilot randomised controlled trial
Secondary ID [1] 300584 0
None
Universal Trial Number (UTN)
Trial acronym
ROCKER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 316318 0
Condition category
Condition code
Musculoskeletal 314586 314586 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention : Pair of appropriately sized, commercially available rocker sole shoes (MBT GT Series, Massai International, Switzerland). Participants will be instructed to wear their allocated shoes as much as possible every day during the 3 month trial period, in place of their usual shoes. Adherence will be documented at 4 and 12 weeks by review of self-complete questionnaire.
Intervention code [1] 316890 0
Treatment: Other
Comparator / control treatment
Control group: Pair of appropriately sized, commercially available running shoes without a rocker sole (Brooks Ghost 12, Brooks Sports, USA). Participants will be instructed to wear their allocated shoes as much as possible every day during the 3 month trial period, in place of their usual shoes. Adherence will be documented at 4 and 12 weeks.
Control group
Active

Outcomes
Primary outcome [1] 322921 0
Participant recruitment (proportion of participants enrolled in the trial from total screened)
Timepoint [1] 322921 0
12 weeks
Primary outcome [2] 322922 0
Outcome measures completed (number of appointments attended [baseline and 12 week] and paper-based outcomes returned [4 weeks], reported as a proportion of total visits/time-points)

Recorded at baseline, 4 and 12 weeks
Timepoint [2] 322922 0
Recorded at baseline, 4 and 12 weeks [primary time-point]
Primary outcome [3] 322923 0
Footwear use/compliance (number of hours participants wore their allocated footwear in the past week)

Recorded at 4 and 12 weeks
Timepoint [3] 322923 0
Recorded at baseline, 4 and 12 weeks [primary time-point]
Secondary outcome [1] 380247 0
Pain domain of the Foot Health Status Questionnaire

Recorded at baseline, 4 and 12 weeks
Timepoint [1] 380247 0
Recorded at baseline, 4 and 12 weeks [primary time-point]
Secondary outcome [2] 380249 0
Function domain of the Foot Health Status Questionnaire

Recorded at baseline, 4 and 12 weeks
Timepoint [2] 380249 0
Recorded at baseline, 4 and 12 weeks [primary time-point]
Secondary outcome [3] 380250 0
Foot pain intensity (average and worst in past 24 hours) and during walking in the last week, measured using an 11-point numerical rating scale (0 to 10)

Recorded at baseline, 4 and 12 weeks
Timepoint [3] 380250 0
Recorded at baseline, 4 and 12 weeks [primary time-point]
Secondary outcome [4] 380251 0
Global change in foot symptoms, measured using a seven-point scale ranging from 1 (very much worse) to 7 (very much improved)

Recorded at 4 and 12 weeks
Timepoint [4] 380251 0
Recorded at 4 and 12 weeks [primary time-point]
Secondary outcome [5] 380252 0
Health-related quality of life (physical and mental component sub-scales), measured using the Short-Form 12 (v2)

Recorded at baseline, 4 and 12 weeks
Timepoint [5] 380252 0
Recorded at baseline, 4 and 12 weeks [primary time-point]
Secondary outcome [6] 380253 0
Physical activity, measured using the International Physical Activity Questionnaire (IPAQ) short form, a 7 item self-report questionnaire that covers the frequency and duration of vigorous and moderate physical activity, walking and sitting over the past 7 days

Recorded at baseline, 4 and 12 weeks
Timepoint [6] 380253 0
Recorded at baseline, 4 and 12 weeks [primary time-point]
Secondary outcome [7] 380254 0
Credibility and expectancy relating to the intervention, measured using the credibility and expectancy questionnaire (CEQ)

Recorded at baseline
Timepoint [7] 380254 0
Recorded at baseline
Secondary outcome [8] 380255 0
Footwear comfort (overall, shoe cushioning, flexibility & stability), measured in the past week using the Running Shoe Comfort Assessment Tool (RUN-CAT)

Recorded at 4 and 12 weeks
Timepoint [8] 380255 0
Recorded at baseline, 4 and 12 weeks [primary time-point]
Secondary outcome [9] 380256 0
Adverse events, defined as any unwanted event that may or may not be related to the intervention. Self-reported by participants using a custom designed questionnaire.

Recorded at 4 and 12 weeks
Timepoint [9] 380256 0
Recorded at 4 and 12 weeks [primary time-point]
Secondary outcome [10] 380257 0
Overall satisfaction with intervention during the study period, measured using the overall item of the Treatment Helpfulness Questionnaire (11-point rating scale ranging from 'extremely harmful' to 'extremely helpful')

Recorded at 12 weeks
Timepoint [10] 380257 0
Recorded at 12 weeks [primary time-point]
Secondary outcome [11] 380258 0
Presence and severity of bone marrow lesions (BMLs) in the midfoot, measured using 1.5T MRI and the Foot Osteoarthritis Magnetic Resonance Imaging Score (FOAMRIS, Halstead et al 2017)

Measured at baseline and 12 weeks
Timepoint [11] 380258 0
Measured at baseline and 12 weeks [primary time-point]

Eligibility
Key inclusion criteria
(i) Aged equal or greater than 18 years
(ii) Midfoot pain (in at least one foot) for equal or greater than 3 months of average severity >2/10 on a 0-10 rating scale in the past week
(iii) Midfoot osteoarthritis on x-ray, defined as a score of >1 for osteophytes or joint space narrowing for the talonavicular, navicular-cuneiform, 1st or 2nd cuneiform-metatarsal joints. Scored using the LaTrobe Radiographic Foot OA Atlas (Menz et al 2007)
(iv) Willing and able to attend clinics on 2 occasions
(v) Willing and able to attend 2 times for MRI scans and once for footwear fitting
(vi) Willing to not receive additional interventions for their midfoot pain during the study
(vii) Willing to discontinue pain medications for their midfoot pain for 7 days prior to baseline assessments and for the duration of the study (except paracetamol up to 4g/day).
(viii) Able to commit to the study for 3 months
(ix) Able to walk household distances unaided
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) Previous foot bone or joint surgery on the foot of interest, or corticosteroid injection to the midfoot in past 3 months
(ii) Currently wearing custom-made footwear or foot orthoses prescribed by a health care professional
(iii) Significant foot deformity precluding footwear fitting
(iv) History of inflammatory condition, fibromyalgia or peripheral neuropathy
(v) Other medical condition likely to impact on participant follow-up during study period (i.e. malignancy)
(vi) Other clinically significant joint pain (e.g. back, hip, knee) that is of greater intensity than midfoot pain at the time of the study, which may confound pain assessments
(vii) Currently pregnant
(viii) Body mass index (BMI) equal or greater than 40kg/m2
(ix) Cognitive impairment
(x) History of falls (2 or more in the past year)
(xi) Have contraindications to MRI

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)
Participants will be randomly allocated to the intervention and control groups (1:1). The schedule will be computer generated and hosted in a password protected web-based service
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Follow-up assessment of clinical outcome measures will be via self-complete questionnaires
Assessment of imaging outcomes will be conducted blinded to group allocation
Statistical analysis will be conducted blinded to group allocation
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
This pilot trial will assess key outcomes relating to trial feasibility (recruitment, intervention use and adverse events), and clinical effects of the footwear (foot pain, function and midfoot joint structure on MRI). This information is necessary to inform and plan a future, fully-powered randomised controlled trial.

The sample size for this pilot trial will be 30 participants (15 per arm), based on published guidelines for pilot studies (Bell et al 2018, Clin Epi; 10:153-157).

Feasibility/methodological outcomes will be reported descriptively.
Within-group changes in clinical outcomes will be reported descriptively, and between group differences in continuous outcomes will be analysed using an analysis of covariance (ANCOVA), adjusting for baseline values. Ordinal or dichotomous data will be analysed using non-parametric tests, as appropriate. Effect sizes for between group differences will also be computed. The level of significance will be set at 0.05. Statistical analysis will be undertaken using SPSS (v26, IBM, USA).

Recruitment
Recruitment status
Not yet recruiting
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)
SA
Recruitment hospital [1] 15918 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [2] 15919 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment postcode(s) [1] 29383 0
5011 - Woodville
Recruitment postcode(s) [2] 29384 0
5112 - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 305006 0
Charities/Societies/Foundations
Name [1] 305006 0
The Hospital Research Foundation
Address [1] 305006 0
60 Woodville Road
Woodville, SA 5011
Country [1] 305006 0
Australia
Funding source category [2] 305016 0
Government body
Name [2] 305016 0
SA Health
Address [2] 305016 0
11 Hindmarsh Square
Adelaide, SA 5000
Country [2] 305016 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
GPO Box 2471
Adelaide, SA 5001
Country
Australia
Secondary sponsor category [1] 305373 0
None
Name [1] 305373 0
Address [1] 305373 0
Country [1] 305373 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 305403 0
Central Adelaide Local Health Network (CALHN) Human Research Ethics Committee
Ethics committee address [1] 305403 0
Level 3, Roma Mitchell House
136 North Terrace, ADELAIDE SA 5000
Ethics committee country [1] 305403 0
Australia
Date submitted for ethics approval [1] 305403 0
01/03/2020
Approval date [1] 305403 0
Ethics approval number [1] 305403 0

Summary
Brief summary
Osteoarthritis (OA) of the midfoot is a painful and disabling condition affecting 1 in 8 people aged over 50 years. Despite the high prevalence and burden of midfoot OA, there is very little evidence to guide the non-surgical management of this condition. Rocker sole shoes are a type of footwear designed to ‘offload’ the painful midfoot and despite anecdotal evidence to support their use in clinical practice, their efficacy has not been thoroughly investigated. Our multidisciplinary team will conduct a pilot randomised controlled trial (RCT) to gather information on feasibility and investigate the potential benefits of rocker sole footwear for painful midfoot OA, which is necessary to plan a rigorous RCT. Adults with painful midfoot OA (n=30) will be randomly allocated to receive either a pair of rocker sole footwear or standard footwear for 12 weeks. This study will assess key outcomes relating to trial feasibility (primary outcomes: recruitment, intervention use and adverse events) and if the footwear affects pain levels, foot-related disability and midfoot joint structure on MRI.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100258 0
Dr John Arnold
Address 100258 0
Allied Health & Human Performance
University of South Australia
Adelaide, South Australia, 5001
Country 100258 0
Australia
Phone 100258 0
+61 8 8302 1329
Fax 100258 0
+61 8 8302 2766
Email 100258 0
john.arnold@unisa.edu.au
Contact person for public queries
Name 100259 0
Dr John Arnold
Address 100259 0
Allied Health & Human Performance
University of South Australia
Adelaide, South Australia, 5001
Country 100259 0
Australia
Phone 100259 0
+61 8 8302 1329
Fax 100259 0
+61 8 8302 2766
Email 100259 0
john.arnold@unisa.edu.au
Contact person for scientific queries
Name 100260 0
Dr John Arnold
Address 100260 0
Allied Health & Human Performance
University of South Australia
Adelaide, South Australia, 5001
Country 100260 0
Australia
Phone 100260 0
+61 8 8302 1329
Fax 100260 0
+61 8 8302 2766
Email 100260 0
john.arnold@unisa.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?
Individual participant data underlying published results
When will data be available (start and end dates)?
After trial completion. No end date determined.
Available to whom?
Researchers upon reasonable request
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approvals by Principal Investigator by emailing john.arnold@unisa.edu.au
What supporting documents are/will be available?
No other documents available
Summary results
No Results