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Trial registered on ANZCTR


Registration number
ACTRN12615001252505
Ethics application status
Approved
Date submitted
6/11/2015
Date registered
16/11/2015
Date last updated
16/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The clinical and cost effectiveness of shoe inserts in people with established rheumatoid arthritis
Scientific title
The clinical and cost-effectiveness of foot orthoses in people with established rheumatoid arthritis: an exploratory trial
Secondary ID [1] 287801 0
None
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
rheumatoid arthritis 296685 0
Condition category
Condition code
Inflammatory and Immune System 296916 296916 0 0
Rheumatoid arthritis
Physical Medicine / Rehabilitation 296917 296917 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two foot orthoses were prescribed over 16 weeks and included: (1) Custom-made foot orthoses and (2) simple insoles. The custom-made foot orthoses were manufactured from high density ethyl vinyl acetate, with a thickness of 20mm and a shore density of 50, a contoured medial arch, high heel cup and external medial posting correction customised to each patient according to the amount of valgus rearfoot deformity present and maximum forefoot balancing technique, determined by the external manufacturer providing the interventions (Langer Biomechanics Group, Cheadle, UK). All foot orthoses were covered with 1.6mm cushioning material extending the length of the foot. The simple insoles were a simple 6mm cushioning insole made from a breathable foam core on a rubber-silicone-ethylene compound, cut to fit the exact shape of the participants’ footwear. Both interventions were the same top colour.

Each participant was asked to wear the foot orthoses or simple insole as frequently as possible. Each participant completed a diary with the number of hours worn during the week and any adverse events.
Intervention code [1] 293197 0
Treatment: Devices
Comparator / control treatment
Participants were randomly allocated to receive either custom-made foot orthoses in the intervention group, or SIs in the control group.
Control group
Active

Outcomes
Primary outcome [1] 296525 0
Foot Pain. Foot pain was measured using the Foot Function Index. The Foot function Index is a self-administered questionnaire consisting of 23-items grouped in three domains: foot pain (nine items), disability (nine items) and functional limitation (five items). Higher scores indicate greater pain, disability and limitation of activity and thus poorer foot health.
Timepoint [1] 296525 0
Baseline and 16 weeks
Primary outcome [2] 296526 0
We estimated the effects on health related quality of life (utilities) of the intervention and the control and undertook a cost-utility analysis using QALYs as the measure of effect. We estimated participant utilities by administering the EQ5D instrument at baseline and 16 weeks; combined them with the area under the curve method to calculate QALY gains over the 16 week study period; and corrected for baseline EQ5D. We estimated the cost per QALY gain by dividing differences in cost by differences in QALYs and compared by the thresholds recommended by NICE
Timepoint [2] 296526 0
Baseline and 16 weeks
Secondary outcome [1] 318676 0
Foot impairment. Foot impairment was used using the Foot Function Index.
Timepoint [1] 318676 0
Baseline and 16 weeks

Eligibility
Key inclusion criteria
Participants were eligible if they were over 18 years old, history of foot pain, ability to walk a required distance of 5 metres for measurement of foot function and had a diagnosis of RA according to the American Rheumatism Association revised criteria.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants with a history of previous foot surgery or ulceration, those with an unstable medical regime or in a state of flare, currently using foot orthoses or unwilling to change their footwear to accommodate an orthotic, or with poor language ability or inability to understand the research protocol were excluded

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)
Simple random allocation was used. A plan for allocating to either intervention or control groups was independently generated using randomisation software available from St George’s Hospital Medical School website, http://www.sgul.ac.uk/depts/chs/chs_research/stat_guide/guide.cfm.

Participants were recruited by the primary researcher and once baseline data had been collected the primary researcher contacted the independent investigator for group allocation. Participants were blinded to the intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A plan for allocating to either experimental or control groups was generated by one supervisor using randomisation software available from St George’s Hospital Medical School website, http://www.sgul.ac.uk/depts/chs/chs_research/stat_guide/guide.cfm (accessed January 2006). The software applied was ‘Randomisation.com’.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We analysed data in SPSS version 22.0 (SPSS Inc., Chicago II, USA) and MS Excel 2010 (Microsoft Corporation, Redmond, Washington DC, USA). Results were reported according to the CONSORT statement. All descriptive data and health status measurements were obtained at baseline and 16 weeks. All participant data was included in the final data analysis to ensure continuity of balance in both arms of the trial to reduce bias. All data was subjected to tests for accuracy and quality before analysis was undertaken. Normalcy tests were also undertaken to ensure the data was normally. No transformation of data was undertaken. Differences between the two groups were determined by analysis of covariance (ANCOVA), to assess the impact of the two different FOs interventions on participant’s scores across the time periods of the trial. Where appropriate, as when dealing with categorical data, non-parametric tests such as Mann Whitney U tests were used. R (R-Foundation for Statistical Computing, Vienna, Austria) and Statistical Analysis Software (SAS Institute Inc) using the sub-heading Proc Mixed for the ANCOVA. Differences between and within groups were presented as mean differences and 90% confidence intervals (CI). This has been recommended as an appropriate confidence level and also as a way of discouraging reinterpretation of the CI as significant or non-significant at the 5% level.

Because of the small numbers of participants in our trial we performed boot-strapped t-tests to estimate the differences between utilities at each of the three time points and report means and standard deviations of the boot-strapped samples. To estimate effects on quality-adjusted life years (QALYS), we performed a linear regression with QALY gain as the dependent variable with treatment group and baseline utility as independent variables. To quantify the uncertainty around the estimated incremental cost effectiveness ratio, we ran a simulation of 1000 non-parametric bootstrapped iterations using R to generate a cost-effectiveness plane and a cost utility acceptability curve. The cost effectiveness plane shows the joint distribution of incremental costs and effects. The cost effectiveness acceptability curve using a net benefit technique also shows the probability that an intervention is more cost-effective than the alternative across a range of threshold values of willingness to pay for a QALY. The level of statistical significance was set at 0.05.

Sample Size: For a large effect size (d) of 0.8, it was calculated that the trial would require 20 or 28 participants per group (40 or 56 in total) to detect group differences with 80% and 90% power respectively. For a smaller effect size (d) of 0.5, it was calculated that the trial would require 51 or 70 participants per group to have 80% and 90% power. Over the one year recruitment period a total of 41 patients were recruited to the trial. From the above calculations this was estimated to be sufficient to have 80% power to detect a large effect size.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/06/2006
Date of last participant enrolment
Anticipated
Actual
10/09/2007
Date of last data collection
Anticipated
Actual
Sample size
Target
52
Accrual to date
Final
41
Recruitment outside Australia
Country [1] 7295 0
United Kingdom
State/province [1] 7295 0

Funding & Sponsors
Funding source category [1] 292334 0
Charities/Societies/Foundations
Name [1] 292334 0
Arthritis Research UK
Country [1] 292334 0
United Kingdom
Primary sponsor type
University
Name
University of Teesside
Address
Health and Social Care Institute
School of Health and Social Care
Teesside University
Middlesbrough
TS1 3BA
UK
Country
United Kingdom
Secondary sponsor category [1] 291013 0
None
Name [1] 291013 0
Address [1] 291013 0
Country [1] 291013 0
Other collaborator category [1] 278693 0
Individual
Name [1] 278693 0
Professor John Dixon
Address [1] 278693 0
Health and Social Care Institute
School of Health and Social Care
Teesside University
Middlesbrough
TS1 3BA
UK
Country [1] 278693 0
United Kingdom
Other collaborator category [2] 278694 0
Individual
Name [2] 278694 0
Dr Joanna Gray
Address [2] 278694 0
Department of Healthcare,
Faculty of Health and Life Science,
Northumbria University,
Newcastle, NE7 7AX. UK
Country [2] 278694 0
United Kingdom
Other collaborator category [3] 278695 0
Individual
Name [3] 278695 0
Dr Heidi Clark
Address [3] 278695 0
South Tees Hospitals NHS Foundation Trust
Podiatry Department
Marton Road
Middlesbrough
TS1 3QY, UK
Country [3] 278695 0
United Kingdom
Other collaborator category [4] 278696 0
Individual
Name [4] 278696 0
Dr Peter McMeeken
Address [4] 278696 0
Department of Healthcare,
Faculty of Health and Life Science,
Northumbria University,
Newcastle, NE7 7AX. UK
Country [4] 278696 0
United Kingdom
Other collaborator category [5] 278697 0
Individual
Name [5] 278697 0
Dr Michael Plant
Address [5] 278697 0
South Tees Hospitals NHS Foundation Trust
James Cook University Hospital
Rheumatology Department
Marton Road
Middlesbrough
TS1 3QY, UK
Country [5] 278697 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293799 0
South Tees NHS Trust and School of Health Research Ethics Committee
Ethics committee address [1] 293799 0
Ethics committee country [1] 293799 0
United Kingdom
Date submitted for ethics approval [1] 293799 0
03/02/2003
Approval date [1] 293799 0
03/03/2003
Ethics approval number [1] 293799 0
02/03/61: A study to evaluate the cost-effectiveness, functional ability and quality of life of foot orthoses in rheumatoid arthritic patients

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61362 0
Prof Keith Rome
Address 61362 0
AUT University
90 Akoranga Drive,
AA Building,
Northcote 0627,
Auckland

Country 61362 0
New Zealand
Phone 61362 0
0064-9-921-9999 ext 7688
Fax 61362 0
Email 61362 0
krome@aut.ac.nz
Contact person for public queries
Name 61363 0
Keith Rome
Address 61363 0
AUT University
90 Akoranga Drive,
AA Building,
Northcote 0627,
Auckland
Country 61363 0
New Zealand
Phone 61363 0
0064-9-921-9999 ext 7688
Fax 61363 0
Email 61363 0
krome@aut.ac.nz
Contact person for scientific queries
Name 61364 0
Keith Rome
Address 61364 0
AUT University
90 Akoranga Drive,
AA Building,
Northcote 0627,
Auckland
Country 61364 0
New Zealand
Phone 61364 0
0064-9-921-9999 ext 7688
Fax 61364 0
Email 61364 0
krome@aut.ac.nz

No information has been provided regarding IPD availability


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
EmbaseClinical effectiveness and cost-effectiveness of foot orthoses for people with established rheumatoid arthritis: an exploratory clinical trial.2017https://dx.doi.org/10.1080/03009742.2016.1196500
N.B. These documents automatically identified may not have been verified by the study sponsor.