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Trial registered on ANZCTR


Registration number
ACTRN12619000926134
Ethics application status
Approved
Date submitted
18/06/2019
Date registered
3/07/2019
Date last updated
3/07/2019
Date data sharing statement initially provided
3/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Foot ORthoses for big Toe joint osteoarthritis: the FORT randomised controlled trial
Scientific title
Effect of Foot ORthoses on pain severity in big Toe joint osteoarthritis: the FORT randomised controlled trial.
Secondary ID [1] 298491 0
Nil known
Universal Trial Number (UTN)
U1111-1235-2710
Trial acronym
FORT (Foot ORthoses for big Toe joint osteoarthritis)
Linked study record
none

Health condition
Health condition(s) or problem(s) studied:
First metatarsophalangeal (big toe) joint osteoarthritis 313273 0
Condition category
Condition code
Musculoskeletal 311717 311717 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This randomised controlled trial (RCT) involves an intervention group and a control group. Participants in both groups will have two visits with a study podiatrist in weeks 1 and 3, booked following completion of the baseline questionnaire by a study researcher. The initial consultation will be 30 minutes and the follow-up visit will be 15-minute 2 weeks later.

The intervention group will receive foot orthoses, for both feet, protocolised (whilst allowing some individual variation) to ensure consistency based on findings from our international survey (Paterson et al 2018, Osteoarthritis & Cartilage). Specifically, a blue (medium-density) FormthoticTM prefabricated foot orthotic, moulded from 140kg/m3 single-density, closed-cell polyethylene foam, (Foot Science International, Christchurch, New Zealand) will be prescribed, and modified using a first MTP joint cut out for joint rotation. If the participant does not have available first MTP joint range of motion (i.e. zero degrees), or if the cut out elicits immediate pain on walking, then a first ray extension will be used instead. Participants with a Foot Posture Index (FPI) score >7 will also have a full length 4° varus wedge (Formthotics, Foot Science International, Christchurch, New Zealand) adhered to the plantar surface of the orthoses. Orthoses will be trimmed (if needed) and fitted into participant’s footwear at the initial visit. At this time, participants will be advised to initially commence wearing the orthoses for 1 hour on the first day and to increase use by an additional hour each day, until they are wearing them at all times when shod for 12 weeks. The orthoses will be reviewed at the follow up visit, and additional orthoses modifications to address comfort or adverse events may be provided (and documented), if necessary.

Adherence to the intervention will be monitored via self-report of insole and shoe wear in a log book once per month for a one-week period, and by using an 11-point NRS for overall adherence at the 12-week follow-up time point.

The control group conditions are described below under 'Comparator / control treatment'

The alternate insole type will be concealed from participants for the duration of the trial.

Intervention code [1] 314742 0
Treatment: Devices
Comparator / control treatment
Participants in the control group will be provided with a sham flat 3mm prefabricated insole for each foot that is the same colour, density and has the same branding as the contoured foot orthoses used in the intervention group, but without the heel and arch support. The flat insole will be trimmed (if needed) and fitted to the participant’s footwear at the initial visit. At this time, participants will be advised to initially commence wearing the flat insole for 1 hour on the first day, and to increase use by an additional hour each day, until they are wearing them at all times when shod for the 12 weeks. Control group participants will be reviewed at a follow up visit two weeks later, and additional modifications (such as trimming to improve shoe fit) to address comfort or adverse events may be made (and documented) if necessary.
Control group
Placebo

Outcomes
Primary outcome [1] 320412 0
Severity of first metatarsophalangeal (MTP) joint pain during walking.

Scored on an 11-point numerical rating scale (NRS) for average overall pain on walking in the last week. The scale ranges from 0 to 10; where 0=no pain and 10=worst pain possible.
Timepoint [1] 320412 0
Baseline and 12 weeks post commencement of treatment
Secondary outcome [1] 371496 0
Foot Health Status Questionnaire (FHSQ) pain subscale.

Scored using 4 questions related to foot pain, each rated on a 5-point Likert scale from 0 (not at all) to 4 (extremely). Responses are recoded to provide a score between 0 (worst foot health) to 100 (best foot health)
Timepoint [1] 371496 0
Baseline and 12 weeks post commencement of treatment
Secondary outcome [2] 371497 0
Foot Health Status Questionnaire (FHSQ) physical function subscale.

Scored using 4 questions related to how much foot pain interferes with specific activities, each rated on a 5-point Likert scale from 0 (not at all) to 4 (extremely). Responses are recoded to provide a score between 0 (worst foot health) to 100 (best foot health)
Timepoint [2] 371497 0
Baseline and 12 weeks post commencement of treatment
Secondary outcome [3] 371498 0
Severity of first MTP joint pain overall.

Scored on an 11-point numerical rating scale (NRS) for average overall pain in the last week. Ranges from 0 to 10; where 0=no pain and 10=worst pain possible.
Timepoint [3] 371498 0
Baseline and 12 weeks post commencement of treatment
Secondary outcome [4] 371499 0
Global improvement in pain

Scored using a 7-point global rating of change Likert scale from with response options ranging from “much worse” to “much better” when compared to baseline. Participants indicating they are “moderately better” or “much better” will be classified as improved. All other respondents will be classified as not improved.
Timepoint [4] 371499 0
12 weeks post commencement of treatment
Secondary outcome [5] 371500 0
Quality of life.

Scored using the 20-item Assessment of Quality of Life II Instrument (6D version), which covers the topics of Independent Living, Relationships, Mental Health, Coping, Pain and Senses to come up with one overall value representing quality of life. Total score ranges from -0.04 to 1.00; higher scores indicate better quality of life.
Timepoint [5] 371500 0
Baseline and 12 weeks post commencement of treatment
Secondary outcome [6] 371501 0
Physical Activity Scale for the Elderly (PASE) score.

A self-reported assessment of physical activity, covering occupational, household and leisure items over the past week with one overall value representing physical activity level. Total score ranges from 0 to 400+; higher scores indicate greater activity.
Timepoint [6] 371501 0
Baseline and 12 weeks post commencement of treatment
Secondary outcome [7] 371502 0
Co-intervention use

Participants will complete a custom-developed table to indicate the frequency of use (over the past 12 weeks) of a range of pain and arthritis medications and co-interventions. Participants who indicate they have used a drug/supplement at least once a week in the past month will be reported as a current user of the relevant medication. Participants who have used a co-intervention once in the past 12 weeks will be reported as a current user of the co-intervention.
Timepoint [7] 371502 0
Baseline and 12 weeks post commencement of treatment
Secondary outcome [8] 371503 0
Adverse events

Adverse events will be defined as any new problem experienced in the study foot or elsewhere in the body (e.g. the development of new lower extremity pain). These will be self-reported by participants using a custom-developed table. Proportions of participants experiencing adverse events will be reported.
Timepoint [8] 371503 0
12 weeks post commencement of treatment
Secondary outcome [9] 371504 0
Pain at other sites

Scored as (1) number of pain sites, and (2) using an 11-point NRS for average overall pain in the last week for each site. (1) Number, and (2) ranges from 0 to 10; where 0=no pain and 10=worst pain possible.
Timepoint [9] 371504 0
Baseline and 12 weeks post commencement of treatment
Secondary outcome [10] 371505 0
Self-rated adherence with insoles over 12 weeks

Rated by participants using an 11-point NRS for overall adherence over the 12 weeks where 0=insoles not worn at all when shod and 10=insoles worn when shod completely as instructed. Ranges from 0 to 10; higher scores indicate better adherence.
Timepoint [10] 371505 0
12 weeks post commencement of treatment
Secondary outcome [11] 371507 0
Percentage of time wearing the study insoles when shod per day

Insole and shoe wear will be recorded in a log book once per month for a one-week period, and percentage of time wearing insoles when shod will be calculated. Percentage of shod hours wearing study insoles will be reported.
Timepoint [11] 371507 0
Weeks 4, 8 and 12 post commencement of treatment
Secondary outcome [12] 371509 0
Number of participants who stopped wearing the study insoles

Participants will indicate whether they stopped wearing the study insoles for the remainder of the study during the 12 weeks on a categorical scale (Yes or No). Participants who score Yes will describe when and why they ceased wearing the insoles, and this will be reported descriptively.
Timepoint [12] 371509 0
12 weeks post commencement of treatment
Secondary outcome [13] 372047 0
Global improvement in physical function

Scored using a 7-point global rating of change Likert scale from with response options ranging from “much worse” to “much better” when compared to baseline. Participants indicating they are “moderately better” or “much better” will be classified as improved. All other respondents will be classified as not improved.
Timepoint [13] 372047 0
12 weeks post commencement of treatment
Secondary outcome [14] 372048 0
Global improvement overall

Scored using a 7-point global rating of change Likert scale from with response options ranging from “much worse” to “much better” when compared to baseline. Participants indicating they are “moderately better” or “much better” will be classified as improved. All other respondents will be classified as not improved.
Timepoint [14] 372048 0
12 weeks post commencement of treatment

Eligibility
Key inclusion criteria
i) aged 45 years or older,
ii) report first MTP joint pain on most days of the month for at least 12 weeks,
iii) report a minimum pain score of 3 on an 11-point numerical rating scale during walking over the previous week,
iv) evidence of radiographic osteoarthritis (OA) (a score of 2 or more for osteophytes or joint space narrowing according to a radiographic atlas), due to a lack of accepted clinical diagnostic criteria for first MTP joint OA, and
v) report either no morning joint-related stiffness in the 1st MTP joint, or morning stiffness that lasts no longer than 30 minutes.
Minimum age
45 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) previous foot surgery or planned surgery on the affected side in the next 12 weeks;
ii) current use of foot orthoses or ankle braces,
iii) current primary use of high heels, thongs or other shoes that would restrict ability to wear orthoses,
iv) had any foot injections on the affected side in the past 6 months or planned injections in next 12 weeks,
v) self-report any other current muscular, joint or neurological condition affecting lower limb function,
vi) self-report any systemic or inflammatory joint disease (eg rheumatoid arthritis),
vii) grade 3 or 4 hallux valgus on the affected side,
viii) current or planned use of a gait aid in the next 12 weeks,
ix) inability to understand written/spoken English,
x) unable to commit to study requirements (eg wearing insoles, attending appointments, completing outcomes).

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 contoured foot orthoses group or the sham flat insoles group.
Participants will not be informed about the insole characteristics provided to the comparison group. Participants will not be informed about the study hypotheses, or which group they are allocated to, until the study is completed, at which time they will be provided with a lay summary of the study purpose, hypotheses and findings.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated to the contoured foot orthoses group or the sham flat insoles group using a randomization schedule prepared by the study biostatistician. Randomization will occur according to a 1: 1 allocation (permuted block sizes 6 to 12) with varying sizes of 6 to 12, stratified by podiatrist. 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
We aim to detect the minimum clinically important difference (MCID) on the primary outcome between groups (1.8 out of 10 units on NRS for walking pain). We conservatively assume a between-participant SD of 2.5 and a baseline to 12-week correlation of 0.3 based on our pilot RCT data. Using ANCOVA adjusted for baseline score, we need 37 per arm to achieve 90% power to detect the MCID in pain. Allowing for 15% attrition, we will recruit 44 people per arm in total (n=88).

A biostatistician will analyse blinded data. Main comparative analyses between groups will be performed using intention-to-treat. If more than 5% of primary outcomes are missing multiple imputation will be applied. For the primary hypothesis, differences in mean change in pain (baseline minus follow-up) will be compared between groups using linear regression models adjusted for baseline value of the primary outcome and stratified by podiatrist. Similar analyses will be conducted for continuous secondary outcomes. Improvement based on global change will be compared across groups using risk differences, calculated from fitted logistic regression models. A sensitivity analysis will estimate treatment effects assuming full adherence (at all times when shod) to wear of the shoes, using an instrumental variables approach. Standard diagnostic plots will be used to check model assumptions.

To assess whether the effect of insole group on the primary outcome of pain is moderated by any of the variables of BMI, a composite score for osteophyte or joint space narrowing, or first MTP joint range of motion, appropriate interaction terms between randomised group and each of these variables will be included in regression models for the primary outcome, for each potential effect modifier separately.

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)
NSW,QLD,VIC
Recruitment postcode(s) [1] 26791 0
3010 - University Of Melbourne

Funding & Sponsors
Funding source category [1] 303036 0
Government body
Name [1] 303036 0
National Health and Medical Research Council (NHMRC)
Address [1] 303036 0
GPO Box 1421
Canberra ACT 2601
Country [1] 303036 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Centre for Health Exercise and Sports Medicine
Department of Physiotherapy
School of Health Sciences
Level 7, Alan Gilbert Building
University of Melbourne VIC 3010
Country
Australia
Secondary sponsor category [1] 303018 0
None
Name [1] 303018 0
Address [1] 303018 0
Country [1] 303018 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303589 0
University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 303589 0
Office of Research Ethics & Integrity
Level 4, 161 Barry Street
The University of Melbourne
VIC 3010
Ethics committee country [1] 303589 0
Australia
Date submitted for ethics approval [1] 303589 0
30/04/2019
Approval date [1] 303589 0
07/06/2019
Ethics approval number [1] 303589 0
1954551

Summary
Brief summary
The overall aim of this research is to compare the effects of using special contoured insoles compared to flat insoles in people who suffer painful osteoarthritis (OA) in their big toe joint. To test this, participants who have big toe OA and are eligible to take part in the study, will be allocated into two different insole groups via a random process. All participants will see a podiatrist who will provide one pair of insoles (either flat or contoured depending on which group they are in), which they will be instructed to wear at all times when wearing shoes for the following 12 weeks.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94174 0
Dr Kade Paterson
Address 94174 0
Centre for Health Exercise and Sports Medicine
Department of Physiotherapy
School of Health Sciences
Level 7, Alan Gilbert Building
University of Melbourne VIC 3010
Country 94174 0
Australia
Phone 94174 0
+61 3 8344 0425
Fax 94174 0
Email 94174 0
kade.paterson@unimelb.edu.au
Contact person for public queries
Name 94175 0
Dr Sarah Jones
Address 94175 0
Centre for Health Exercise and Sports Medicine
Department of Physiotherapy
School of Health Sciences
Level 7, Alan Gilbert Building
University of Melbourne VIC 3010
Country 94175 0
Australia
Phone 94175 0
+61 3 9035 6517
Fax 94175 0
Email 94175 0
jones.s@unimelb.edu.au
Contact person for scientific queries
Name 94176 0
Dr Kade Paterson
Address 94176 0
Centre for Health Exercise and Sports Medicine
Department of Physiotherapy
School of Health Sciences
Level 7, Alan Gilbert Building
University of Melbourne VIC 3010
Country 94176 0
Australia
Phone 94176 0
+61 3 8344 0425
Fax 94176 0
Email 94176 0
kade.paterson@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data sharing may be negotiated on an individual basis
What supporting documents are/will be available?
No other documents available
Summary results
No Results