Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000987167
Ethics application status
Approved
Date submitted
24/06/2019
Date registered
11/07/2019
Date last updated
29/06/2021
Date data sharing statement initially provided
11/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Foot Exercise and Education in the Treatment of plantar heel pain (FEET trial): A feasibility study.
Scientific title
Foot Exercise and Education versus brief advice in the Treatment of plantar heel pain (FEET trial): A feasibility study.
Secondary ID [1] 298337 0
None
Universal Trial Number (UTN)
Trial acronym
The FEET Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plantar heel pain 312983 0
Condition category
Condition code
Musculoskeletal 311489 311489 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 311946 311946 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Foot exercise and education

This group will attend eight individual (one on one) physiotherapy sessions during the twelve-week intervention period. Sessions will be scheduled at week 1, 2, 3, 4, 5, 6, 8 and 10. Each physiotherapy session will be 30 minutes duration. At the first session participants will be prescribed a progressive exercise programme for the intrinsic foot muscles and receive detailed education relating to self-management strategies. Subsequent sessions will involve review and reinforcement of the self-management strategies and review and progression (as able) of the exercise programme. Participants will be asked to maintain a daily logbook to record exercises performed, symptoms, other physical activity performed, details of adverse events and details of treatment outside the study.

The 12 week exercise programme comprises 2 components:
1) Daily exercises: Will be performed daily throughout the 12 week intervention and consists of 4 foot and toe movements and 2 weight bearing exercises. Exercises will take approximately 5 minutes to complete.
2) Exercises to perform 3 times a week: 4 exercises will be performed 3 times per week throughout the 12 week intervention. The exercises include: doming, resisted toe flexion, seated heel raise and standing heel raise. To allow for progression, 3 stages of each exercise are provided. Progression is provided by varying the number of repetitions and sets, amount of load, or rate of loading. Progression is individualised and made when the indicated repetitions and sets are reached for that stage, provided that (i) the therapist considers that patient can recruit adequate intrinsic muscle contraction without excessive extrinsic contribution, or perform local joint motion at the foot and ankle with optimal control i.e. smooth motion through intended plane of action without unintended overflow into adjacent planes or joints; (ii) the participant’s rating of subjective effort of each exercise using Modified Borg Scale is 0-5 / 10, (iii) the participant’s pain response to loading (remains <5/10 on a numerical rating scale). Exercises will take approximately 20 minutes to complete.

The education component will include information about the condition and self-management strategies including monitoring of load and symptom response and advice regarding footwear, posture and gait. This will be delivered at the one-on-one by the physiotherapist at the first session and supported by the provision of a handout (brochure) detailing all of the information discussed with the physiotherapist. The handout has been specifically designed for this study. Review and reinforcement of self-management strategies will be included at all subsequent physiotherapy sessions.
Intervention code [1] 314576 0
Rehabilitation
Intervention code [2] 314577 0
Treatment: Other
Comparator / control treatment
Brief Advice
This group will attend one individual (one on one) session with a physiotherapist. of approximately 30 minutes duration. Participants will be given brief information about the condition, advised that complete rest is seldom beneficial but to keep activity within acceptable levels of pain, and reassurance that in majority of individuals the condition often resolves over time. This discussion with the physiotherapist will be supported by a handout (brochure). Participants will be asked to maintain a weekly logbook that records symptoms, any problems encountered and action taken (treatments).
Control group
Active

Outcomes
Primary outcome [1] 320193 0
Feasibility is a composite outcome and will be assessed by:
- the willingness of participants to enrol (assessed from trial screening database)
- number of eligible participants (assessed from trial screening database)
- recruitment rates (assessed from trial screening database)
- adherence with the foot exercise intervention (assessed by return of participant logbook and number of physiotherapy sessions attended)
- log book completion (assessed by return of participant logbook)
- adverse effects (assessed by return of participant logbook and treatment notes recorded by the physiotherapists)
- drop out rates (assessed from trial database)
Timepoint [1] 320193 0
Assessed at completion of data collection
Primary outcome [2] 320194 0
Credibility of treatment will be evaluated using the Borkovec and Nau questionnaire which consists of 6 items related to the credibility and expectancy of treatment received.
Timepoint [2] 320194 0
Baseline and 12 weeks
Primary outcome [3] 320195 0
Acceptability of the foot exercise intervention in a composite outcome and will assessed by:
- the number of sessions attended (assessed by return of treatment notes from physiotherapists)
- adherence to the foot exercise intervention (assessed by return of participant logbook)
- additional treatments sought (assessed by return of participant logbook)
- reasons for early withdrawal, if any (assessed from trial database)
Timepoint [3] 320195 0
Assessed at completion of data collection
Secondary outcome [1] 370821 0
Pain Numerical Rating Scale: An 11 point scale anchored by no pain at all at 0 and worst pain
imaginable at 10 will be used to rate first step, worst and average level of pain the patient experienced in the past week.
Timepoint [1] 370821 0
Baseline, 12 weeks
Secondary outcome [2] 370822 0
Global Rating of Change Score: an 11-point scale in which the participant is asked to rate their perceived overall change in condition of their heel pain from the time that they began the study until the present.
Timepoint [2] 370822 0
12 weeks
Secondary outcome [3] 370824 0
The Foot and Ankle Ability Measure: 21-items of activities of daily living and an 8-item sports subscale will be rated by the patient on a 5-point scale as ‘no difficulty’ through to ‘unable to do’, and converted to a score where 100 represents full function.
Timepoint [3] 370824 0
Baseline, 12 weeks
Secondary outcome [4] 370826 0
The Foot Health Status Questionnaire: 13-items that assess multiple dimensions of foot health and function and converted to a score where 0 represents poor foot health and 100 optimal foot health.
Timepoint [4] 370826 0
Baseline, 12 weeks
Secondary outcome [5] 370827 0
The Pain Self-Efficacy Questionnaire: Consists of 10-items and will be used to assess the confidence participants have in performing activities while in pain.
Timepoint [5] 370827 0
Baseline, 12 weeks
Secondary outcome [6] 370828 0
Intrinsic foot muscle morphology: 7 Tesla magnetic resonance imaging will be used to measure volume of the intrinsic muscles of the foot. Ultrasound imaging will be used to measure cross-sectional area and thickness of the intrinsic muscles of the foot.
Timepoint [6] 370828 0
Baseline, 12 weeks
Secondary outcome [7] 371099 0
Foot posture: The Foot Posture Index will be used to classify static foot posture.
Timepoint [7] 371099 0
Baseline, 12 weeks
Secondary outcome [8] 371100 0
Physical activity level: The Active Australia Survey will be used to measure participation in leisure-time physical activity.
Timepoint [8] 371100 0
Baseline, 12 weeks
Secondary outcome [9] 371527 0
Plantar flexor strength/endurance: Will be measured using the Standing Heel Rise Test. Participants will be asked to lift the heel as high as possible for each heel rise, until no further repetitions can be performed. The number of heel rises completed will be recorded.
Timepoint [9] 371527 0
Baseline, 12 weeks.
Secondary outcome [10] 371528 0
Toe flexor strength: Maximal voluntary strength of the hallux and lesser toe flexors will be assessed using hand held dynamometry.
Timepoint [10] 371528 0
Baseline, 12 weeks.
Secondary outcome [11] 371924 0
Ankle dorsiflexion range of motion: Weight-bearing ankle dorsiflexion range of movement will be measured during the lunge test using a customised device for linear measurement.
Timepoint [11] 371924 0
Baseline, 12 weeks
Secondary outcome [12] 372206 0
Foot mobility: Measurement of dorsal arch height and midfoot width obtained in weight bearing and non-weight bearing positions will be performed using a customised platform with rulers and callipers, and used to calculate foot mobility (arch height difference, midfoot difference, foot mobility magnitude).
Timepoint [12] 372206 0
Baseline, 12 weeks
Secondary outcome [13] 372207 0
Intrinsic foot muscle motor performance: Motor performance and the participant's perceived difficulty during four foot movement tasks will be assessed.
Timepoint [13] 372207 0
Baseline, 12 weeks
Secondary outcome [14] 375370 0
Plantar fascia thickness: Ultrasound imaging will be used to measure the thickness of the plantar fascia.
Timepoint [14] 375370 0
Baseline, 12 weeks

Eligibility
Key inclusion criteria
• history of insidious onset pain under the sole of the foot at the heel of at least 3 months duration
• pain that is most noticeable with initial steps following a period of inactivity but also worsened with prolonged weight bearing
• pain in the previous week at least 3/10 on a numerical rating scale
• pain on palpation of medial calcaneal tubercle or proximal fascia
• plantar fascia thickness greater than 4mm as measured on ultrasound imaging
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• aged below 18 years
• corticosteroid injections at the foot during the preceding 6 months
• pregnant or breastfeeding
• medical history of diabetes or an inflammatory systemic disease
• history of foot pathology or previous surgery
• pain or an injury of the lower limb (other than heel pain) in the preceding 6 months that caused them to seek medical assistance or treatment, take medication, miss work, or reduce physical activity for at least one week
• are unable to undergo MRI (e.g. metal implants, pacemaker)

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomization schedule allocating on a 1:1 ratio to each group and in random permuted blocks of 2-6.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Feasibility trial
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/07/2019
Actual
2/08/2019
Date of last participant enrolment
Anticipated
Actual
8/11/2019
Date of last data collection
Anticipated
31/01/2020
Actual
31/01/2020
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 26586 0
4000 - Brisbane

Funding & Sponsors
Funding source category [1] 302878 0
University
Name [1] 302878 0
The University of Queensland
Country [1] 302878 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
St Lucia, Brisbane, QLD 4072
Country
Australia
Secondary sponsor category [1] 302832 0
None
Name [1] 302832 0
Address [1] 302832 0
Country [1] 302832 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303454 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [1] 303454 0
Ethics committee country [1] 303454 0
Australia
Date submitted for ethics approval [1] 303454 0
02/04/2019
Approval date [1] 303454 0
31/05/2019
Ethics approval number [1] 303454 0
2019000772

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93710 0
Dr Melinda Smith
Address 93710 0
School of Health and Rehabilitation Sciences
Therapies Building 84A
Therapies Road
University of Queensland
St Lucia QLD 4072
Country 93710 0
Australia
Phone 93710 0
+61 7 3365 1379
Fax 93710 0
Email 93710 0
[email protected]
Contact person for public queries
Name 93711 0
Melinda Smith
Address 93711 0
School of Health and Rehabilitation Sciences
Therapies Building 84A
Therapies Road
University of Queensland
St Lucia QLD 4072
Country 93711 0
Australia
Phone 93711 0
+61 7 3365 1379
Fax 93711 0
Email 93711 0
[email protected]
Contact person for scientific queries
Name 93712 0
Melinda Smith
Address 93712 0
School of Health and Rehabilitation Sciences
Therapies Building 84A
Therapies Road
University of Queensland
St Lucia QLD 4072
Country 93712 0
Australia
Phone 93712 0
+61 7 3365 1379
Fax 93712 0
Email 93712 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data collected during the trial.
When will data be available (start and end dates)?
Immediately following publication, no end date determined.
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Request made in writing to the Principal Investigator (Email [email protected])


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.