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Trial registered on ANZCTR


Registration number
ACTRN12613001245785
Ethics application status
Approved
Date submitted
8/11/2013
Date registered
13/11/2013
Date last updated
17/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Rocker-sole footwear versus prefabricated foot orthoses for the treatment of pain associated with first metatarsophalangeal joint osteoarthritis: a parallel-group randomised trial
Scientific title
Comparison of the effectiveness of rocker-sole footwear versus prefabricated foot orthoses for the treatment of pain in people with first metatarsophalangeal joint osteoarthritis
Secondary ID [1] 283554 0
NHMRC APP1040985
Universal Trial Number (UTN)
U1111-1150-0710
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
First metatarsophalangeal joint osteoarthritis 290460 0
Condition category
Condition code
Musculoskeletal 290852 290852 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Pair of commercially-available rocker-sole shoes (MBT Matwa, Masai Barefoot Technology, Switzerland), characterized by a rounded sole in the anterior–posterior direction and a soft cushioned heel. Participants will be asked to wear the footwear as often as possible/practical during the 12 week trial period. Adherence will be documented at 4, 8 and 12 weeks. Participants will provide information concerning the number of hours per day and number of days they have worn their rocker-sole shoes during the previous 4 weeks.
Intervention code [1] 288246 0
Treatment: Devices
Comparator / control treatment
Prefabricated orthoses group: Pair of individualised, prefabricated foot orthoses (Vasyli Customs, Vasyli Medical [trademark], Labrador, Queensland, Australia), that will be modified using a first ray cut-outs and 3 mm open cell polyurethane foam forefoot extensions (Poron [registered trademark], Rogers Corp., Rogers, CT, USA).

Participants will be asked to wear the orthoses as often as possible/practical during the 12 week trial period.

Adherence will be documented at 4, 8 and 12 weeks. Participants will provide information concerning the number of hours per day and number of days they have worn their prefabricated orthoses during the previous 4 weeks.
Control group
Active

Outcomes
Primary outcome [1] 290848 0
Pain domain of the Foot Health Status Questionnaire.

Measured at baseline, 4, 8 and 12 weeks.
Timepoint [1] 290848 0
12 weeks.
Secondary outcome [1] 305430 0
Function domain of the Foot Health Status Questionnaire.

Measured at baseline, 4, 8 and 12 weeks.
Timepoint [1] 305430 0
12 weeks.
Secondary outcome [2] 305431 0
The Foot Function Index - Revised (Short Form).

Measured at baseline and 12 weeks.
Timepoint [2] 305431 0
12 weeks.
Secondary outcome [3] 305432 0
Severity of pain at the first metatarsophalangeal joint (MTPJ) during walking over a flat surface and during rest, during the last 48 hours (via a 100 mm visual analog scale).

Measured at baseline, 4, 8 and 12 weeks.
Timepoint [3] 305432 0
12 weeks.
Secondary outcome [4] 305433 0
Severity of stiffness at the first MTPJ after first awakening in the morning during the last 48 hours (via a 100 mm visual analog scale).

Measured at baseline, 4, 8 and 12 weeks.
Timepoint [4] 305433 0
12 weeks.
Secondary outcome [5] 305434 0
Global change in symptoms using a 15-point Likert scale (marked improvement, moderate improvement, same, moderate worsening, marked worsening).
Timepoint [5] 305434 0
12 weeks.
Secondary outcome [6] 305435 0
Health-related quality of life (using the Short-Form-12 Version 2 questionnaire).

Measured at baseline, 4, 8 and 12 weeks.
Timepoint [6] 305435 0
12 weeks.
Secondary outcome [7] 305436 0
Use of paracetamol rescue medication (number of participants and mean consumption) and co-interventions to relieve pain at the first MTPJ, collected with a monthly diary.
Timepoint [7] 305436 0
12 weeks.
Secondary outcome [8] 305437 0
Incidental and Planned Exercise Questionnaire, a self-report questionnaire that covers the frequency and duration of several levels of planned and incidental physical activity.

Measured at baseline and 12 weeks.
Timepoint [8] 305437 0
12 weeks.

Eligibility
Key inclusion criteria
(i) be aged at least 18 years
(ii) report having pain in the first MTPJ for at least 12 weeks
(iii) report having pain rated at least 20mm on a 100mm visual analogue scale
(iv) have less than 64 degrees of dorsiflexion range of motion of the first MTPJ
(v) have pain upon palpation of the dorsal aspect of the first MTPJ
(vi) be able to walk household distances (>50 meters) without the aid of a walker, crutches or cane
(vi) be willing to attend the Health Sciences Clinic at La Trobe University (Melbourne, Victoria) for an initial assessment
(vii) be willing to not receive additional interventions (such as physical therapy, foot orthoses, shoe modifications, intra-articular injections, or surgery) for the first MTPJ pain during the course of the study
(viii) be willing to discontinue taking all pain-relieving medications to relieve pain at their first MTPJ (analgesics and non-steroidal anti-inflammatory medications [NSAIDs], except paracetamol up to 4g/day) for at least 14 days prior to the baseline assessment and during the study period. Participants who do take paracetamol for first MTPJ pain need to discontinue its use at least 24 hours prior to the baseline assessment and follow-up assessments at 4 and 12 weeks.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) pregnancy
(ii) previous surgery on the first MTPJ
(iii) significant deformity of the first MTPJ including hallux valgus (grade of 3 or 4 scored using the Manchester Scale)
(iv) presence of one or more conditions within the foot or ankle, in the opinion of the investigators, could confound pain and functional assessments of the first MTPJ, such as metatarsalgia, plantar fasciitis, pre-dislocation syndrome, Achilles tendinopathy, degenerative joint disease (other than the first MTPJ)
(v) presence of any systemic inflammatory condition, such as inflammatory arthritis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, reactive arthritis, septic arthritis, acute pseudogout, gout or any other connective tissue disease
(vi) any medical condition that, in the opinion of the investigators, makes the participant unsuitable for inclusion (e.g., severe progressive chronic disease, malignancy, clinically important pain in a part of the musculoskeletal system other than the first MTPJ, or fibromyalgia)
(vii) cognitive impairment (defined as a score of <7 on the Short Portable Mental Status Questionnaire)
(viii) intra-articular injections into the first MTPJ in the previous 6 months
(ix) currently wearing contoured foot orthoses (although flat insoles will be permitted)
(x) currently wearing specialised footwear (footwear that has been custom-made or ‘prescribed’ by a health-care practitioner)
(xi) currently wearing shoes that would not be able to accommodate a foot orthosis
(xii) older people with a history of recurrent falls (defined as 2 or more falls in the previous 12 months)

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 either the footwear or orthoses group. This will be undertaken using an interactive voice response telephone service provided by the National Health and Medical Research Council Clinical Trials Centre at the University of Sydney, New South Wales, Australia.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation with random block sizes will be undertaken using an interactive voice response telephone service provided by the National Health and Medical Research Council Clinical Trials Centre at the University of Sydney, New South Wales, Australia.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The sample size for the study has been determined using an a priori power analysis based on the primary outcome measure: the pain domain of the Foot Health Status Questionnaire. We have previously determined that the minimal important difference for this measure in people with foot pain is 13 points. Using a standard deviation of 19 (derived from a recent trial), a power level of 0.8, alpha level of 0.05 and accounting for a drop-out rate of 15%, a sample size of 80 participants (i.e. approximately 40 per group) will be required. We have conservatively selected a drop-out rate at the higher end of previous trials of specialised footwear and/or orthoses for lower limb OA (between 2 and 15%).

Statistical analysis will be undertaken using SPSS version 21.0 (IBM Corp, NY, USA) using the intention-to-treat principle for all randomised participants. The exception to this will be the safety outcome measures which will be analysed as treated. In participants with bilateral symptoms, the most painful foot will be analysed. Multiple imputation will be used to replace any missing data using five iterations, with age, baseline scores, and group allocation as predictors. The exception will be for the variables use of rescue medication and co-interventions where no data substitution will be applied. Standard tests to assess continuous data for normal distribution will be used and transformation carried out if required. Differences in the primary and secondary outcome measures between the two groups will be compared. Continuously-scored outcome measures will be analysed using analysis of covariance with baseline scores and intervention group entered as independent variables. Ordinal scaled data will be analysed using non-parametric tests. Dichotomously-scored outcome measures will be compared using relative risk reductions (RRR) and number needed to treat (NNT).

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] 7549 0
3086 - La Trobe University

Funding & Sponsors
Funding source category [1] 288238 0
Government body
Name [1] 288238 0
National Health and Medical Research Council of Australia
Address [1] 288238 0
GHD Building Level 1 16 Marcus Clarke St, Canberra ACT 2601
Country [1] 288238 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Bundoora, Victoria 3086
Country
Australia
Secondary sponsor category [1] 286956 0
None
Name [1] 286956 0
Address [1] 286956 0
Country [1] 286956 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290143 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 290143 0
La Trobe University, Bundoora, Victoria 3086
Ethics committee country [1] 290143 0
Australia
Date submitted for ethics approval [1] 290143 0
Approval date [1] 290143 0
02/07/2013
Ethics approval number [1] 290143 0
13-003

Summary
Brief summary
Osteoarthritis affecting the first metatarsophalangeal joint of the foot is a common condition which results in pain, stiffness and impaired ambulation. Footwear modifications and foot orthoses are widely used in clinical practice to treat this condition, but their effectiveness has not been rigorously evaluated. The aim of this study is to compare the effectiveness of rocker-sole footwear and individualised prefabricated foot orthoses in reducing pain associated with first metatarsophalangeal joint osteoarthritis.
Trial website
www.stiffbigtoe.blogspot.com
Trial related presentations / publications
Menz HB, Levinger P, Tan JM, Auhl M, Roddy E, Munteanu SE. Rocker-sole footwear versus prefabricated foot orthoses for the treatment of pain associated with first metatarsophalangeal joint osteoarthritis: study protocol for a randomised trial. BMC Musculoskeletal Disorders 2014;15:86.

Menz HB, Auhl M, Tan J, Levinger P, Roddy E, Munteanu SE. Biomechanical effects of prefabricated foot orthoses and rocker-sole footwear in individuals with first metatarsophalangeal joint osteoarthritis. Arthritis Care and Research 2016;68:603-611.

Menz HB, Auhl M, Tan J, Levinger P, Roddy E, Munteanu SE. Effectiveness of foot orthoses versus rocker-sole footwear for first metatarsophalangeal joint osteoarthritis: randomized trial. Arthritis Care and Research 2016;68:581-589.
Public notes

Contacts
Principal investigator
Name 44166 0
Prof Hylton B Menz
Address 44166 0
Lower Extremity and Gait Studies Program
Faculty of Health Sciences
La Trobe University
Bundoora, Victoria 3086
Country 44166 0
Australia
Phone 44166 0
+61-3-94795801
Fax 44166 0
+61-3-94795415
Email 44166 0
h.menz@latrobe.edu.au
Contact person for public queries
Name 44167 0
Prof Hylton B Menz
Address 44167 0
Lower Extremity and Gait Studies Program
Faculty of Health Sciences
La Trobe University
Bundoora, Victoria 3086
Country 44167 0
Australia
Phone 44167 0
+61-3-94795801
Fax 44167 0
+61-3-94795415
Email 44167 0
h.menz@latrobe.edu.au
Contact person for scientific queries
Name 44168 0
Prof Hylton B Menz
Address 44168 0
Lower Extremity and Gait Studies Program
Faculty of Health Sciences
La Trobe University
Bundoora, Victoria 3086
Country 44168 0
Australia
Phone 44168 0
+61-3-94795801
Fax 44168 0
+61-394795415
Email 44168 0
h.menz@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