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Trial registered on ANZCTR


Registration number
ACTRN12613000051741
Ethics application status
Approved
Date submitted
15/01/2013
Date registered
15/01/2013
Date last updated
12/12/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A case-series study to explore the efficacy and tolerability of full-length shoe stiffening inserts in treating first metatarsophalangeal joint osteoarthritis
Scientific title
In people with first metatarsophalangeal joint osteoarthritis, are full-length shoe stiffening inserts an effective and safe treatment?
Secondary ID [1] 281777 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis of the first metatarsophalangeal joint of the foot 288097 0
Condition category
Condition code
Musculoskeletal 288468 288468 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be given a single (or pair depending if symptoms are bilateral) full-length shoe stiffening insert. The shoe insert will be fabricated from ~1 mm semi-rigid carbon graphite (Otto Bock Springlite Carbon Foot Plates [Registered Trademark]) and will have the following design characteristics: (i) full length, in that the insert extends from the heel to the tip of the toes, (ii) no arch build-up or contour at the heel.

Participants will be advised to wear the shoe insert(s) in the shoe(s) they most frequently wear, and this will differ on a case by case basis.

The intervention will be used for the entire duration of the trial (3 months).

Intervention code [1] 286319 0
Treatment: Devices
Comparator / control treatment
Not applicable (the study is uncontrolled)
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288628 0
Foot Health Status Questionnaire (Foot pain subscale)
Timepoint [1] 288628 0
One month and three months (primary outcome)
Secondary outcome [1] 300652 0
Foot Health Status Questionnaire (foot function subscale)
Timepoint [1] 300652 0
One and three months
Secondary outcome [2] 300654 0
Self-reported magnitude of symptom change (15-point Likert scale)
Timepoint [2] 300654 0
One and three months
Secondary outcome [3] 300656 0
Physical activity (in previous week) (7-day recall questionnaire: Sallis et al., 1985)
Timepoint [3] 300656 0
One and three months
Secondary outcome [4] 300657 0
Use of co-interventions (self-report at one and three month assessments and via a diary)
Timepoint [4] 300657 0
One and three months
Secondary outcome [5] 300658 0
Comfort of shoe inserts (5-point Likert scale)
Timepoint [5] 300658 0
Baseline, one and three months
Secondary outcome [6] 300659 0
Adverse events (self-report at one and three month assessments). Adverse events expected typically include the development of musculoskeletal pain within the lower limb such as Achilles tendon pain, or dermatological lesions such as hyperkeratosis or blistering of the feet.
Timepoint [6] 300659 0
One and three months
Secondary outcome [7] 300660 0
Compliance with shoe inserts (self-report)
Timepoint [7] 300660 0
One and three months
Secondary outcome [8] 300661 0
Dynamic plantar pressures (during walking) with and without shoe inserts
Timepoint [8] 300661 0
Baseline and three months

Eligibility
Key inclusion criteria
(i) aged at least 18 years; (ii) report first metatarsophalangeal (MTPJ) pain for at least 3 months; (iii) report current pain severity of at least 20 mm on a 100 mm visual analogue pain scale at the first MTPJ; (iv) have radiographic evidence of first MTPJ osteoarthritis; (v) willing to discontinue taking all pain-relieving medications for the first MTPJ (except paracetamol) for two weeks prior to the baseline appointment then during the duration of the study; (vii) willing to attempt to refrain from using alternate treatment (such as physical therapy) for the pain at their first MTPJ during the study period; (viii) wear shoes that can accommodate the full-length shoe-stiffening inserts; (ix) able to ambulate without the need for assistive devices such as crutches or cane.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) previous first MTPJ surgery; (ii) intra-articular injection at the first MTPJ in the previous 3 months; (iii) significant deformity of the first MTPJ including bunions; (iv) confounding conditions such as other musculoskeletal pathology of the lower limb(s); (v) inflammatory arthritis (including rheumatoid arthritis, gout, psoriatic arthritis); (vi) presence of diabetes or connective tissue disease (vii) currently wearing full-length shoe stiffening inserts or footwear that is unlikely to accommodate this intervention.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All eligible participants will receive the intervention (case-series study design).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Multiple imputation will be used to replace missing data. Participants treated for bilateral first metatarsophalangeal joint osteoarthritis will be asked to describe symptoms without specific reference to an individual foot (i.e. bilateral pain will be evaluated as one independent sample). Descriptive data will be determined. One-way repeated measures analysis of variance with Bonferroni-adjusted post-hoc tests will be used for comparisons of the outcome measurements of foot pain, foot-related disability (function), and level of physical disability between the initial (baseline) and the one month and three month (primary end-point) time-points (for normally distributed data). Differences in plantar pressures between the shoe only versus shoe plus shoe-stiffening insert at baseline and at 3 months will be assessed using paired samples t-tests (for normally distributed data). Non-normally distributed data will be analysed using non-parametric tests. P-values < 0.05 will be considered statistically significant.

Recruitment
Recruitment status
Completed
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)
VIC
Recruitment postcode(s) [1] 6176 0
3086 - La Trobe University

Funding & Sponsors
Funding source category [1] 286559 0
Self funded/Unfunded
Name [1] 286559 0
Address [1] 286559 0
Country [1] 286559 0
Primary sponsor type
Individual
Name
Shannon Munteanu
Address
Department of Podiatry, La Trobe University VIC 3086
Country
Australia
Secondary sponsor category [1] 285343 0
None
Name [1] 285343 0
Address [1] 285343 0
Country [1] 285343 0
Other collaborator category [1] 277245 0
Individual
Name [1] 277245 0
Hylton Menz
Address [1] 277245 0
Faculty of Health Sciences, La Trobe University VIC 3086
Country [1] 277245 0
Australia
Other collaborator category [2] 277246 0
Individual
Name [2] 277246 0
George Murley
Address [2] 277246 0
Department of Podiatry, La Trobe University VIC 3086
Country [2] 277246 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288627 0
La Trobe University, Faculty of Health Sciences Human Ethics Committee
Ethics committee address [1] 288627 0
Faculty of Health Sciences
La Trobe University
Melbourne VIC 3086
Ethics committee country [1] 288627 0
Australia
Date submitted for ethics approval [1] 288627 0
31/10/2012
Approval date [1] 288627 0
03/12/2012
Ethics approval number [1] 288627 0
FHEC12/188

Summary
Brief summary
Project aim:
The aim of this project is to determine the effectiveness and tolerability of full-length shoe-stiffening inserts for the treatment of osteoarthritis of the big-toe joint of the foot.

Rationale:
Osteoarthritis of the big-toe joint is common and painful. Although full-length shoe-stiffening inserts are a recommended treatment for this condition, the evidence supporting their use is lacking.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37062 0
Dr Shannon Munteanu
Address 37062 0
Department of Podiatry
La Trobe University VIC 3086
Country 37062 0
Australia
Phone 37062 0
+61 03 9479 5866
Fax 37062 0
Email 37062 0
s.munteanu@latrobe.edu.au
Contact person for public queries
Name 37063 0
Dr Shannon Munteanu
Address 37063 0
Department of Podiatry
La Trobe University VIC 3086
Country 37063 0
Australia
Phone 37063 0
+61 03 9479 5866
Fax 37063 0
Email 37063 0
s.munteanu@latrobe.edu.au
Contact person for scientific queries
Name 37064 0
Dr Shannon Munteanu
Address 37064 0
Department of Podiatry
La Trobe University VIC 3086
Country 37064 0
Australia
Phone 37064 0
+61 03 9479 5866
Fax 37064 0
Email 37064 0
s.munteanu@latrobe.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary