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Trial registered on ANZCTR


Registration number
ACTRN12616001290482
Ethics application status
Approved
Date submitted
19/08/2016
Date registered
14/09/2016
Date last updated
23/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A multi-faceted podiatry intervention for first metatarsophalangeal joint osteoarthritis: a pilot randomised controlled trial
Scientific title
A multi-faceted podiatry intervention for first metatarsophalangeal joint osteoarthritis: a pilot randomised controlled trial
Secondary ID [1] 289976 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 299980 0
Condition category
Condition code
Musculoskeletal 299873 299873 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 12 week multi-faceted podiatry treatment consisting of foot orthotics; foot and ankle exercises performed both in the clinic and on a daily basis at home; and education and advice concerning appropriate footwear, analgesia, weight management and general physical activity. These are explained in more detail below:

Foot orthotics: prefabricated device with (a) a first ray cut out unless pain is exacerbated, or (b) a morton's extension if pain is exacerbated with the cut out. People with a FPI score >7 will also have a varus wedge added. After a familiarisation period, participants will be advised to wear their orthotics as much as possible each day, however at a minimmum, they will be advised to wear them for at least 6 hours every day.
Exercises: Performed twice daily for an approximate duration of 20 minutes each, and including (a) Isometric flexor hallucis strengthening (push toe in to ground) performed 10 x 10 seconds, (b) mobilisation performed by first metatarsophalangeal joint distraction (one minute) and glides (one minute), (c) plantar foot massage using a ball for 5 minutes
Advice delivered by the podiatrist during each participant's initial clinical visit (approx 10 minutes). This will include advice on analgesia (a maximum of 4 g/day of paracetamol if needed), weight management (general advice and dietitian referral if needed) and physical activity (30 minutes on most days) will be provided and reinforced with an Arthritis Australia booklet).

Treatment adherence will be self-assessed in a log book and participants will be sent reminder emails by a research assistant.
Intervention code [1] 295670 0
Treatment: Other
Comparator / control treatment
Usual care of simple pain relief and anti inflammatory medication advice/prescription, in addition to general advice regarding exercise and weight loss.
Control group
Active

Outcomes
Primary outcome [1] 299348 0
Proportion of participants recruited from the total number screened
Timepoint [1] 299348 0
12 weeks post commencement of intervention
Primary outcome [2] 299437 0
A composite measure of treatment adherence based on the number of treatment sessions attended (recorded by the clinician), and the number exercise sessions completed (self-reported in a log book)
Timepoint [2] 299437 0
12 weeks post commencement of the intervention
Primary outcome [3] 299438 0
Hours wearing foot orthotics self-reported in a log book
Timepoint [3] 299438 0
12 weeks post commencement of the intervention
Secondary outcome [1] 326905 0
Change in pain on walking over the past week, measured using an 100 mm visual analogue scale (VAS) with terminal descriptors of ‘no pain’ (score 0 mm) and ‘extreme pain’ (score 100 mm),
Timepoint [1] 326905 0
Baseline and 12 weeks post commencement of intervention
Secondary outcome [2] 327143 0
Change in the pain domain of the Foot Health Status Questionnaire (FHSQ)
Timepoint [2] 327143 0
Baseline and 12 weeks post commencement of the intervention
Secondary outcome [3] 327144 0
Self-perceived change in pain, measured using a 7-point ordinal scale, where 1 indicates ‘much worse’ and 7 indicates ‘much better’.
Timepoint [3] 327144 0
12 weeks post commencement of the intervention
Secondary outcome [4] 327145 0
Treatment satisfaction on an 11-point numerical rating scale with ‘not at all satisfied’ at 0 and ‘very satisfied’ at 10
Timepoint [4] 327145 0
12 weeks post commencement of the intervention
Secondary outcome [5] 327147 0
Any adverse events self-reported in a log book
Timepoint [5] 327147 0
12 weeks post commencement of the intervention
Secondary outcome [6] 327148 0
The number of drop-outs
Timepoint [6] 327148 0
12 weeks post commencement of the intervetion
Secondary outcome [7] 327305 0
Change in the function domain of the Foot Health Status Questionnaire (FHSQ)
Timepoint [7] 327305 0
Baseline and 12 weeks post commencement of the intervention
Secondary outcome [8] 327306 0
Self-perceived change in physical function, measured using a 7-point ordinal scale, where 1 indicates ‘much worse’ and 7 indicates ‘much better’.
Timepoint [8] 327306 0
12 weeks post commencement of the intervention

Eligibility
Key inclusion criteria
Participants aged over 40 with symptomatic radiographic first metatarsophalangeal joint osteoarthritis. First metatarsophalangeal joint osteoarthritis will be defined as radiographic osteoarthritis (established using a valid and reliable atlas) and corresponding self-reported pain of >40mm on a 100mm visual analogue scale in the past four weeks in one or both of the first metatarsophalangeal joints.
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The main exclusion criteria are:
(i) inflammatory or systemic arthritis or other condition affecting lower limb function,
(ii) use of foot orthotics or intra-articular foot injections in the past six months
(iii) previous musculoskeletal foot surgery;
(iv) grade 3 or 4 hallux valgus;
(v) currently receiving treatment for their first metatarsophalangeal joint osteoarthritis pain;
(vi) medial knee OA or pain; and
(vii) pain in any other location that is worse that their first metatarsophalangeal joint osteoarthritis pain.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised 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
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
This is a proof of concept study designed to generate important feasibility, safety and efficacy data to be used to inform a future large randomised controlled trial. Using confidence intervals to help determine samples size for pilot studies, samples between 10-15 have been suggested to be adequate. Thus we have selected a sample size of 15 individuals per group, or 30 participants in total.

Analysis of covariance (ANCOVA) will be used to compare the effect of each treatment over time (pre/post) on pain and functional outcome measures, with group allocation as the fixed factor and corresponding baseline outcome values as covariates. Alpha will be set at 0.05.

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

Funding & Sponsors
Funding source category [1] 294347 0
Charities/Societies/Foundations
Name [1] 294347 0
Arthritis Australia
Address [1] 294347 0
Level 2/255 Broadway
GLEBE NSW 2037
Country [1] 294347 0
Australia
Funding source category [2] 294348 0
Charities/Societies/Foundations
Name [2] 294348 0
Australian Podiatry and Education Research Foundation
Address [2] 294348 0
89 Nicholson Street
Brunswick East Vic 3057
Country [2] 294348 0
Australia
Primary sponsor type
Individual
Name
Kade Paterson
Address
Centre for Health Exercise and Sports Medicine
Department of Physiotherapy, School of Health Sciences
University of Melbourne, Carlton, Victoria, 3053
Country
Australia
Secondary sponsor category [1] 293186 0
University
Name [1] 293186 0
The University of Melbourne
Address [1] 293186 0
The University of Melbourne, Parkville, Victoria 3010 Australia
Country [1] 293186 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295765 0
Behavioural and Social Sciences Human Ethics Sub-Committee, The University of Melbourne
Ethics committee address [1] 295765 0
Office for Research Ethics and Integrity
The University of Melbourne
Parkville, Victoria, Australia 3010
Ethics committee country [1] 295765 0
Australia
Date submitted for ethics approval [1] 295765 0
16/06/2016
Approval date [1] 295765 0
21/06/2016
Ethics approval number [1] 295765 0
1543656.3

Summary
Brief summary
The purpose of this ‘proof of concept’ study is to investigate a multi-faceted podiatry intervention in people with symptomatic first metatarsophalangeal joint osteoarthritis.

Specific aims are:

1. To determine the feasibility, safety and perceived patient response to a multi-faceted podiatry intervention in people with first metatarsophalangeal joint osteoarthritis.
2. To investigate the efficacy of a multi-faceted podiatry intervention on pain and self-reported function compared to usual care in people with first metatarsophalangeal joint osteoarthritis.

People with first metatarsophalangeal joint osteoarthritis will receive either the podiatry intervention or usual care of analgesia and advice, and feasibility data, as well as changes in pain and function will be assessed after 12 weeks.
Trial website
http://healthsciences.unimelb.edu.au/research2/physiotherapy-research/chesm/foot-pain-study
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68402 0
Dr Kade Paterson
Address 68402 0
Centre for Health Exercise and Sports Medicine
Department of Physiotherapy, School of Health Sciences
University of Melbourne, Carlton, Victoria, 3053
Country 68402 0
Australia
Phone 68402 0
+613 83440425
Fax 68402 0
Email 68402 0
kade.paterson@unimelb.edu.au
Contact person for public queries
Name 68403 0
Dr Kade Paterson
Address 68403 0
Centre for Health Exercise and Sports Medicine
Department of Physiotherapy, School of Health Sciences
University of Melbourne, Carlton, Victoria, 3053
Country 68403 0
Australia
Phone 68403 0
+613 83440425
Fax 68403 0
Email 68403 0
kade.paterson@unimelb.edu.au
Contact person for scientific queries
Name 68404 0
Dr Kade Paterson
Address 68404 0
Centre for Health Exercise and Sports Medicine
Department of Physiotherapy, School of Health Sciences
University of Melbourne, Carlton, Victoria, 3053
Country 68404 0
Australia
Phone 68404 0
+613 83440425
Fax 68404 0
Email 68404 0
kade.paterson@unimelb.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