Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000645853
Ethics application status
Approved
Date submitted
23/04/2021
Date registered
28/05/2021
Date last updated
10/01/2022
Date data sharing statement initially provided
28/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Conservative management of hallux valgus: a randomised pilot and feasibility trial
Scientific title
Efficacy of footwear, foot orthoses and exercise for the conservative management of painful hallux valgus in women: a randomised pilot and feasibility trial
Secondary ID [1] 303159 0
None
Universal Trial Number (UTN)
Trial acronym
MultifAceted inteRVention for haLLux valgus (MARVELL)
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
hallux valgus 320282 0
Condition category
Condition code
Musculoskeletal 318210 318210 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 319720 319720 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The overall duration of the intervention is 12 weeks.

(i) Self-management package: this study-specific pamphlet is based on UK National Health Service recommendations and includes advice to wear wide shoes with a low heel and soft sole, apply cold-packs and silicone gel bunion pads, and use of paracetamol. The silicone gel bunion pads and cold packs will be provided. The self-management package is delivered in a single 10-15 session with a podiatrist. Adherence to the self-management package will be assessed via structured questionnaire at the 4, 8 and 12 week follow-up periods.

(ii) Footwear: high quality, off-the-shelf footwear (Anodyne Sport Jogger) with a sufficiently wide toe-box to alleviate pressure on the hallux. The shoes will be correctly fitted by a research podiatrist, and participants will be asked to wear them as often as possible.

(iii) Foot orthoses: prefabricated Formthotics(TM) (Foot Science International, Christchurch, New Zealand). These orthoses are ¾ length and are constructed from 140 kg/m3 single-density, closed-cell polyethylene foam. Participants will be asked to wear these with their footwear as often as possible. Adherence to the footwear/orthoses intervention will be documented using 4-weekly diaries and objectively assessed over 12 weeks using a small (9×13×4.5 mm) temperature sensor embedded in the shoe (Orthotimer, Balingen, Germany). Time, date, and temperature measurements are stored every 15 minutes.

(iv) Foot exercises: participants will be provided with a booklet, smart-phone app (Physitrack®) and webpage which demonstrates a home-based version of the progressive resistance foot exercise program. The set of 9 exercises are performed three times per week for the 12 weeks. Each session takes approximately 30 minutes to complete. Most of the exercises are performed in a seated position using resistance rubber bands (TheraBand®, Akron, OH, USA) wrapped around the toes and/or foot. The exercises target the muscles responsible for ankle dorsiflexion, ankle inversion/eversion, hallux and lesser toe flexion and hallux abduction, and are progressed by either increasing the number of times the exercises are performed (repetitions) or by increasing the level of resistance provided by the bands (light to extra heavy). Participants will be contacted by videoconference every 2 weeks to address any questions they have and to ensure that the exercises are being performed correctly. Adherence to the exercise program will be documented using 4-weekly diaries and the Physitrack® smart-phone app.
Intervention code [1] 319844 0
Treatment: Devices
Intervention code [2] 319845 0
Rehabilitation
Comparator / control treatment
The control group will receive the same self-management package as the intervention group, The study-specific pamphlet is based on UK National Health Service recommendations and includes advice to wear wide shoes with a low heel and soft sole, apply cold-packs and silicone gel bunion pads, and use of paracetamol. The silicone gel bunion pads and cold packs will be provided. The self-management package is delivered in a single 10-15 session with a podiatrist. Adherence to the self-management package will be assessed via structured questionnaire at the 4, 8 and 12 week follow-up periods.
Control group
Active

Outcomes
Primary outcome [1] 326665 0
The primary outcome is feasibility, which will be evaluated according to demand, acceptability, adherence, adverse events and retention rate. The measures and thresholds required to demonstrate feasibility are described below:

Demand
Demand will be determined by the conversion rate (the proportion of participants providing consent of those who met the selection criteria) and recruitment rate (the number of participants recruited per month). Conversion rate will be considered acceptable if 75% or more and recruitment rate will be considered acceptable if 6 eligible participants are recruited per month.

Acceptability
Acceptability of the intervention will be determined using questions from the Monitor Orthopaedic Shoes (MOS) questionnaire which addresses issues such as appearance, comfort, weight, ease of donning and doffing. The intervention will be considered acceptable if 75% or more of the intervention group score more than 5/10 for each of questions 1-6.

Adherence
Adherence to the footwear/orthoses intervention will be objectively assessed over 12 weeks using a small (9×13×4.5 mm) temperature sensor embedded in the shoe (Orthotimer, Balingen, Germany). Time, date, and temperature measurements are stored every 15 minutes. Adherence will be considered acceptable if 75% or more participants wear the footwear/orthoses for an average of 5 or more hours per day. Adherence to the exercise program will be documented using weekly postal diaries (or the Physitrack® smart-phone app) and will be considered acceptable if 75% or more participants attempt at least 66% of the total number of exercise sessions (i.e., 24 out of 36 sessions). In the control group, adherence to using the bunion pads and hot/cold packs will be measured using 4-weekly diaries.

Adverse events
Adverse events will be assessed at 4 weekly intervals via postal survey. Participants will be asked to document the type of adverse event, the body location, the frequency and/or severity of the effect. An independent assessor will assess all adverse events as unrelated, probably related or definitely related, and only those considered to be probably or definitely related will be considered an adverse event. Serious adverse events will be defined as events that are life-threatening, require hospitalisation, or result in persistent or significant disability or incapacity. The rate of adverse events will be considered acceptable if it is less than 15% and none are considered serious.

Retention rate
Retention rate is the proportion of recruited participants who complete the 12-week outcome assessment. An 80% or more retention rate will be considered acceptable.
Timepoint [1] 326665 0
Conversion rate: baseline.
Acceptability: baseline.
Adherence (footwear/orthoses): continuous up to 12 weeks.
Adherence (exercise): weekly up to 12 weeks.
Adherence (bunion pads / hot packs): weeks 4, 8 and 12.
Adverse events: weeks 4, 8 and 12.
Retention rate: 12 weeks.
Secondary outcome [1] 392317 0
Limited efficacy testing: The key outcome measure is the pain subscale of the Manchester-Oxford Foot Questionnaire (MOXFQ). The MOXFQ consists of 16 items reflecting 3 subscales (pain, walking/standing and social interaction). The pain subscale consists of 5 items scored on a five-point Likert scale (0 to 4; ‘4’ assigned ‘most severe’; higher scores denoting higher severity). The score for each subscale is calculated as the sum of each individual item score and is expressed on a metric of 0 to 100 (100 times actual score, divided by the maximum possible domain score). The MOXFQ pain domain will be measured at baseline and at 4-weekly intervals (i.e. weeks 4, 8 and 12). To avoid over-testing associated with serial measurements (i.e., Type 1 error), the pre-specified primary endpoint will be the 12-week score. The minimum clinically important difference for the MOXFQ pain subscale is 12 points.
Timepoint [1] 392317 0
Assessed at baseline, 4, 8 and 12 weeks.
Secondary outcome [2] 395809 0
Manchester-Oxford Foot Questionnaire walking subscale.
Timepoint [2] 395809 0
Assessed at baseline, 4, 8 and 12 weeks.
Secondary outcome [3] 395810 0
Manchester-Oxford Foot Questionnaire social subscale.
Timepoint [3] 395810 0
Assessed at baseline and 4, 8 and 12 weeks.
Secondary outcome [4] 395811 0
Foot and ankle muscle strength, measured with a hand-held dynamometer.
Timepoint [4] 395811 0
Assessed at baseline and 12 weeks.
Secondary outcome [5] 395812 0
General health-related quality of life, assessed using Short Form-12.
Timepoint [5] 395812 0
Assessed at baseline and 4, 8 and 12 weeks.
Secondary outcome [6] 395813 0
Number of participants using co-interventions, assessed using a study-specific questionnaire.
Timepoint [6] 395813 0
Assessed at 4, 8 and 12 weeks.
Secondary outcome [7] 395814 0
Participants’ perception of overall treatment effect, assessed with the question “Overall, how has your foot pain changed since the start of the study?” and using a global impression of change 15-point Likert scale response (ranging from “a very great deal worse” to “a very great deal better”).
Timepoint [7] 395814 0
Assessed at 12 weeks.

Eligibility
Key inclusion criteria
To be eligible for inclusion, participants must:

(i) be aged >=40 years;
(ii) be female;
(iii) have pain in the toe joint/s (i.e. first metatarsophalangeal or interphalangeal) for at least 12 weeks;
(iv) have pain in the toe joint/s (i.e. first metatarsophalangeal or interphalangeal) rated at least 3 out of 10 on a numerical rating scale;
(v) be able to walk household distances (more than 50 m) without the aid of a walker, crutches or cane;
(vi) be capable of understanding the English language in verbal and written form, and;
(vii) have at least moderate hallux valgus on one or both feet, defined as a score of 2 or more on the validated Manchester scale, a tool containing four standardised photographs of varying degrees of hallux valgus deformity.
Minimum age
40 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will not be eligible for inclusion if they have:

(i) had surgical treatment for hallux valgus on either foot;
(ii) had a lower limb or partial foot amputation;
(iii) have an inflammatory rheumatological condition such as gout, rheumatoid arthritis, psoriatic arthritis, axial spondyloarthropathy or connective tissue disease, (iv) have a neurological disease which interferes with walking (e.g. Parkinson’s disease);
(v) have worn arch-contouring foot orthoses in the past 12 weeks (although flat insoles will be permitted);
(vi) have been performing foot exercises (stretching, mobilisation or strengthening) in the past 12 weeks, or;
(vii) have an injury of lower limb(s) or back that may interfere with reaching their feet.

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)
Permuted block randomisation will be used to randomly allocate participants on a 1:1 ratio to the control or intervention groups using an online randomisation service (www.sealedenvelope.com).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation.
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
Safety/efficacy
Statistical methods / analysis
As this is a feasibility study our focus will not be on statistical testing. Instead, we will be presenting baseline characteristics between intervention and control groups and describing the reported changes (for example improvements in pain) in the intervention group. Mean (SD) scores and mean differences (95% CI) will be used to explore differences between continuous variables. Differences in the MOXFQ pain subscale between groups at 12 weeks (adjusted for baseline differences) will be used to inform the sample size calculation for the main randomised trial.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/06/2021
Actual
8/07/2021
Date of last participant enrolment
Anticipated
30/04/2022
Actual
Date of last data collection
Anticipated
30/05/2022
Actual
Sample size
Target
28
Accrual to date
15
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 33274 0
3086 - La Trobe University

Funding & Sponsors
Funding source category [1] 307568 0
University
Name [1] 307568 0
La Trobe University
Country [1] 307568 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University
Kingsbury Drive
Bundoora
Victoria 3086
Country
Australia
Secondary sponsor category [1] 308700 0
None
Name [1] 308700 0
Address [1] 308700 0
Country [1] 308700 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307627 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 307627 0
La Trobe University
Kingsbury Drive
Bundoora
Victoria 3086
Ethics committee country [1] 307627 0
Australia
Date submitted for ethics approval [1] 307627 0
Approval date [1] 307627 0
21/12/2020
Ethics approval number [1] 307627 0
HEC20474

Summary
Brief summary
The primary objective of this study is to evaluate the feasibility of conducting a trial comparing the efficacy of a multifaceted, non-surgical intervention (including self-management advice, footwear, foot orthoses and foot exercises) versus usual care (self-management advice) for reducing pain associated with hallux valgus (also known as 'bunions') in women aged 40 years and over. Feasibility will be assessed using measures of demand, acceptability, adherence, adverse events and drop-out rate. The secondary objective is to obtain statistical parameters to inform the main trial sample size calculation and providing signal of efficacy to justify the future main trial.
Trial website
http://www.hyltonbmenz.com/p/marvell.html
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107914 0
Prof Hylton Menz
Address 107914 0
School of Allied Health, Human Services and Sport
La Trobe University
Kingsbury Drive
Bundoora
Victoria 3086
Country 107914 0
Australia
Phone 107914 0
+61394795801
Fax 107914 0
Email 107914 0
h.menz@latrobe.edu.au
Contact person for public queries
Name 107915 0
Prof Hylton Menz
Address 107915 0
School of Allied Health, Human Services and Sport
La Trobe University
Kingsbury Drive
Bundoora
Victoria 3086
Country 107915 0
Australia
Phone 107915 0
+61394795801
Fax 107915 0
Email 107915 0
h.menz@latrobe.edu.au
Contact person for scientific queries
Name 107916 0
Prof Hylton Menz
Address 107916 0
School of Allied Health, Human Services and Sport
La Trobe University
Kingsbury Drive
Bundoora
Victoria 3086
Country 107916 0
Australia
Phone 107916 0
+61394795801
Fax 107916 0
Email 107916 0
h.menz@latrobe.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only.
When will data be available (start and end dates)?
Start: immediately following publication
End: No end date
Available to whom?
Researchers who provide a methodologically sound proposal.
Available for what types of analyses?
IPD meta-analyses.
How or where can data be obtained?
Subject to approvals by Principal Investigator, Prof Hylton Menz (h.menz@latrobe.edu.au).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10819Study protocolThe study protocol will be published in an open access journal.  



Results publications and other study-related documents

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