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Trial registered on ANZCTR


Registration number
ACTRN12616000168459
Ethics application status
Approved
Date submitted
9/12/2015
Date registered
10/02/2016
Date last updated
29/11/2018
Date data sharing statement initially provided
29/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Functional foot orthoses effectiveness in patients with Rheumatoid Arthritis
Scientific title
Functional foot orthoses vs placebo: Effectiveness in reducing pain and disability in patients with Rheumatoid Arthritis
Secondary ID [1] 288114 0
None
Universal Trial Number (UTN)
Trial acronym
FORA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid arthritis and related feet problems 296986 0
Condition category
Condition code
Musculoskeletal 297237 297237 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 297717 297717 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Investigator M (podiatrist) will manufactured a pair of customized foot orthoses per participant asigned to the experimental group. A weight-bearing phenolic foam cast will be obtained previously from these participants. Foot orthoses will consist of 2 mm-thick polypropylene from heel to inmediately proximal to the metatarsal heads, a 5 mm-thick, 35-40 shore A, ethylene-vinyl superior sheet, personalized subdigital crest and rearfoot posting. Participants in experimental group will be encouraged to wear these foot orthoses during 3 months, at least 8 hours a day, in a physiologic shoe (wide tip shoe and less than 4 cm heel). To monitor adherence to the intervention monthly reviews are scheduled.
Intervention code [1] 293423 0
Treatment: Devices
Comparator / control treatment
The placebo intervention will consist in using a 5 mm-thick, 35-40 shore A, ethylene-vinyl acetate flat sheet (without adaptation to the positive cast) during the same follow up period than the experimental group, and in similar conditions.
Control group
Placebo

Outcomes
Primary outcome [1] 296822 0
The Visual Analogue Scale pain (VAS) is a continuous quantitative variable.
This measure instrument has been traditionally used for measuring foot pain. It consists of a line of 10 centimeter divided into 10 sections where 0 means no pain and 10 means the maximum tolerable pain.
Timepoint [1] 296822 0
Baseline (inmediately before the intervention), 30, 60 and 90 days after the intervention commencement.
Primary outcome [2] 296823 0
The Manchester Foot Pain and Disability Index (MFPDI) is a self assessment questionnaire developed in the UK to measure foot pain and disability. It is based on 19 statements, two of which are related to the difficulty in performing work or leisure activities and are excluded from the questionnaire if the respondent is of a retirement age. The remaining 17 items constitute three constructs (subscales): functional limitation (10 items), pain intensity (5 items) and concern with personal appearance (2 items). Each of the 17 statements has a 3-category response structure: ‘none of the time’ = 0, ‘on some days’ = 1 and ‘on most/every day(s)’ = 2. The MFPDI has been validated in middle-aged and older populations and has been used as an outcome measure both in large population- based surveys and in clinical studies, including randomised controlled trials. The MFPDI has also been used in studies of various diseases with foot manifestations including systemic. sclerosis, Ehlers–Danlos syndrome and rheumatoid arthritis. It has been translated and cross-culturally adapted and validated into Spanish recently.
Timepoint [2] 296823 0
Baseline and 90 days after intervention commencement.
Primary outcome [3] 296824 0
The short form Health Survey (SF-12) is a general health questionnaire. It consists in 12 questions that measure eight dimensions (variables) of quality of life related to health and two abstract components, obtained by applying an algorithm that transforms scores typifies subjects and making them directly comparables 1) Physical Function (PF) 2) Physical role (PR) 3) bodily pain (BP) 4) General Health (GH) 5) Vitality (VT): 6) social functioning (SF): 7) Role emotional(RE) 8) Mental Health (MH)
Timepoint [3] 296824 0
Baseline and 90 days after the intervention commencement
Secondary outcome [1] 319472 0
Nil
Timepoint [1] 319472 0
Nil

Eligibility
Key inclusion criteria
Patients with rheumatoid arthritis which is stable, and related foot alterations
The participants are patients attending the Podiatric Clinical Area of the University of Sevilla.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy, patients with other inflamatory or neurologic diseases, patients with cognitive disorders who do not understand the questionnaries, patients with peripheral neuropathy or peripheral vascular disease, active rheumatoid arthritis, open skin wounds.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample was calculated with an effect size of 0.5, alpha error = 0.05 and power = 0.95, resulting in 40 patients per group. It is planned to compared MFPDI and SF-12 values between both the control and the experimental groups at the beginning and end of the follow up period, and the VAS scale results will be compared between groups at the beginning, and in the 30, 60 and 90-day revision. Statistical Package for Social Sciences (SPSS) will be used.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/11/2016
Actual
14/10/2016
Date of last participant enrolment
Anticipated
9/01/2018
Actual
17/10/2017
Date of last data collection
Anticipated
Actual
22/01/2018
Sample size
Target
80
Accrual to date
Final
68
Recruitment outside Australia
Country [1] 7404 0
Spain
State/province [1] 7404 0
Sevilla

Funding & Sponsors
Funding source category [1] 292531 0
University
Name [1] 292531 0
University of Seville
Country [1] 292531 0
Spain
Primary sponsor type
University
Name
University of Sevilla
Address
Calle Avicena s/n. 41009 Seville
Country
Spain
Secondary sponsor category [1] 291242 0
None
Name [1] 291242 0
Nil
Address [1] 291242 0
Nil
Country [1] 291242 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294326 0
Comite de Bioetica de la Junta de Andalucia
Ethics committee address [1] 294326 0
Ethics committee country [1] 294326 0
Spain
Date submitted for ethics approval [1] 294326 0
12/12/2015
Approval date [1] 294326 0
12/10/2016
Ethics approval number [1] 294326 0

Summary
Brief summary
This study is a randomized controlled trial in patients with rheumatoid arthritis with feet pain, which aims to determine the effectiveness of the rheumatoid arthritis custom made insoles. It is hoped that information gathered from this project will help to contribute to the body of knowledge to an optimal podiatry treatment rheumatoid arthritis patients
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61994 0
Dr Maria Reina-Bueno
Address 61994 0
University of Seville.Calle Avicena s/n CP 41009 Sevilla
Country 61994 0
Spain
Phone 61994 0
+34 954486544
Fax 61994 0
Email 61994 0
[email protected]
Contact person for public queries
Name 61995 0
Maria Reina-Bueno
Address 61995 0
University of Seville. Calle Avicena s/n CP 41009 Sevilla
Country 61995 0
Spain
Phone 61995 0
+34954486544
Fax 61995 0
Email 61995 0
[email protected]
Contact person for scientific queries
Name 61996 0
Maria Reina-Bueno
Address 61996 0
University of Seville. Calle Avicena s/n CP 41009 Sevilla
Country 61996 0
Spain
Phone 61996 0
+34954486544
Fax 61996 0
Email 61996 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.