Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000373875
Ethics application status
Approved
Date submitted
28/01/2021
Date registered
31/03/2021
Date last updated
31/03/2021
Date data sharing statement initially provided
31/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of website education for adults with plantar heel pain: a randomised controlled trial
Scientific title
Effectiveness of website education for adults with plantar heel pain: a randomised controlled trial
Secondary ID [1] 303271 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Plantar heel pain 320457 0
Condition category
Condition code
Musculoskeletal 318348 318348 0 0
Other muscular and skeletal disorders
Anaesthesiology 318794 318794 0 0
Pain management
Public Health 318795 318795 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a parallel-group design comparing the effectiveness of the MyHeelPain website to a control group that is asked to access publicly available information on plantar heel pain (PHP). The MyHeelPain website was designed by researchers at La Trobe University and was based on clinical practice guidelines, expert opinions and people with PHP.

Intervention group (MyHeelPain treatment group)
Participants in the MyHeelPain treatment group will receive access to a password protected website for 6 weeks that is not publicly available. The website is designed to educate participants with heel pain on how to self-­manage their pain based on the current evidence and needs of people with PHP.

This website consists of three main sections:
(1) About heel pain
This section provides information covering a variety of subjects including diagnosis, prognosis, and prevalence of heel pain. Information will be presented in written form and short videos.

(2) Treatments
This section includes treatment options that have been found to be beneficial for PHP (education, taping, foot orthoses, footwear advice and exercises) and information about common treatments with inconsistent evidence (e.g. heel surgery, injections, night splints, strengthening exercises). Information will be presented in written form and short videos.

(3) Do it yourself - a step-by-step plan
This section includes a step-by-step approach to the treatment of PHP including treatments to try at each step and when to progress to the next step. This plan is based on the experience and needs of people with PHP. Information will be presented in written form.

The participants will have access to videos designed to help them undertake specific treatments (e.g. exercise and taping). Options about how to progress the exercises are also provided.

The study will be conducted in an online environment, across all states and territories of Australia (i.e. participants will not be required to attend any face to face assessments or consultations at a physical location).

Website usage over the duration of the study (i.e. 12 weeks) will be entirely at the discretion of participants.

To monitor adherence to the intervention, participants will be required to complete a diary, which will also include how often they accessed internet resources.
Intervention code [1] 319573 0
Treatment: Other
Comparator / control treatment
Participants in the control group are advised to access publicly available online resources for PHP (i.e. via ‘Google’). Control group participants are provided synonyms to help with their search for resources that reflect their diagnosis.

Participants will not be advised to access specific information (e.g. guidelines). Participants will be given some key words (e.g plantar fasciitis, heel spur) and advised to use the internet to access information about the condition including causes and treatment options.

Website usage over the duration of the study (i.e. 12 weeks) will be entirely at the discretion of participants.

All participants will receive a diary to monitor their use of the internet and the type of treatments that they use to treat their heel pain.

To monitor adherence to the intervention, participants will be required to complete a diary, which will also include how often they accessed internet resources.
Control group
Active

Outcomes
Primary outcome [1] 326319 0
General foot pain will be evaluated using the pain domain of the Foot Health Status Questionnaire
Timepoint [1] 326319 0
6 weeks post intervention allocation.
Secondary outcome [1] 391038 0
First step pain will be evaluated using a 100 mm Visual Analogue Scale
Timepoint [1] 391038 0
6 and 12 weeks post intervention allocation
Secondary outcome [2] 391039 0
Foot function will be evaluated using the foot function domain of the Foot Health Status Questionnaire (FHSQ)
Timepoint [2] 391039 0
6 and 12 weeks post intervention allocation
Secondary outcome [3] 391040 0
Depression will be evaluated using the Depression Anxiety and Stress scale (DASS-21)
Timepoint [3] 391040 0
6 and 12 weeks post intervention allocation
Secondary outcome [4] 391041 0
Anxiety will be evaluated using the Depression Anxiety and Stress scale (DASS-21)
Timepoint [4] 391041 0
6 and 12 weeks post intervention allocation
Secondary outcome [5] 391042 0
Stress will be evaluated using the Depression Anxiety and Stress scale (DASS-21)
Timepoint [5] 391042 0
6 and 12 weeks post intervention allocation
Secondary outcome [6] 391043 0
Catastrophizing will be evaluated using the Pain Catastrophizing Scale (PCS)
Timepoint [6] 391043 0
6 and 12 weeks post intervention allocation
Secondary outcome [7] 391044 0
Kinesiophobia will be evaluated using the Tampa Scale for Kinesiophobia (TSK-17)
Timepoint [7] 391044 0
6 and 12 weeks post intervention allocation
Secondary outcome [8] 391045 0
Health literacy will be evaluated using the Health Literacy Questionnaire (HLQ). The HLQ includes 44 items and nine dimensions however only Dimensions 2 and 3 will be included ‘having sufficient information to manage my health’ and ‘actively managing my health’.
Timepoint [8] 391045 0
6 and 12 weeks post intervention allocation
Secondary outcome [9] 391046 0
Digital literacy will be evaluated using a single question on a 0 to 100 mm scale: how confident are you using the internet to understand health information?
Timepoint [9] 391046 0
6 and 12 weeks post intervention allocation

Eligibility
Key inclusion criteria
Inclusion and exclusion criteria will be initially screened using an online survey. Specific questions will be made to fully comprehend the participant’s condition and potential confounders (i.e. exclusion criteria). Questions such as “Have you ever had foot surgery?” and “Do you have pain in other parts of your body other than your feet?” will be asked. Afterwards, inclusion and exclusion criteria will be further confirmed in an online meeting with a clinician (MC – the Principal Investigator).

Participants will be considered potentially eligible if they meet the following criteria:

i. Aged 18 years and over
ii. Pain beneath the heel which corresponds to at least 2 out of 10 on a numerical rating scale (NRS) in the previous week
iii. Pain beneath the heel that has been present for at least 1 month duration
iv. Pain beneath the heel that was of a gradual onset
v. Reside in Australia
vi. Adequate English to complete outcome measures and interact with the MyHeelPain website.
vii. Internet access for the duration of the trial.
viii. Will be willing to attempt to discontinue consuming any pain relieving medications for their heel pain (except paracetamol (up to 4 g per day) which will be rescue medication) for at least 14 days prior to the baseline assessment and during the study period.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from the study if they:
i. Have any self-reported inflammatory arthritis (e.g. seronegative arthropathy), endocrine/neurological condition (e.g. diabetic peripheral neuropathy, stroke, etc.), surgery (e.g. amputation, joint fusion, etc.), or trauma (e.g. major fractures) that had affected lower limb sensation or their ability to walk/run;
ii. Have received a corticosteroid injection, shockwave therapy or custom orthoses in the past 3 months.
iii. Have dementia, cognitive impairment or mental health issues.

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)
A central telephone service will be used to implement the allocation sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Once eligibility is confirmed and the participants agree to participate in the study, they will be randomly assigned to one of two groups. A randomisation list will be developed by an investigator who will not be involved in the recruitment or assessment of participants. Participants will be randomised with a 1:1 allocation for one of two groups: MyHeelPain or a control group. Randomisation codes will be generated in random blocks of 4 and 6 using a custom list at the website (https://www.sealedenvelope.com/).
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
Continuous outcomes measured at 6 and 12 weeks will be analysed using an analysis of covariance (ANCOVA) with baseline scores included as covariates. All continuous data will be checked for its distribution being normally distributed (i.e. to adhere to the assumptions of parametric statistics). We will present mean differences and 95% confidence intervals where appropriate. Non-normally distributed continuous data will be either transformed where appropriate or analysed using Mann-Whitney U tests. Categorical data will be analysed using Chi-square tests. Odds Ratios, Relative Risk and Number Needed to Treat/Harm and 95% confidence intervals may be calculated where appropriate. All analyses will be completed using SPSS® version 26 or later and we consider p<0.05 to be statistically significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2021
Actual
Date of last participant enrolment
Anticipated
3/05/2021
Actual
Date of last data collection
Anticipated
26/07/2021
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment postcode(s) [1] 32850 0
3086 - La Trobe University

Funding & Sponsors
Funding source category [1] 307681 0
University
Name [1] 307681 0
La Trobe University
Country [1] 307681 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] 308380 0
None
Name [1] 308380 0
Address [1] 308380 0
Country [1] 308380 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307717 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 307717 0
Ethics committee country [1] 307717 0
Australia
Date submitted for ethics approval [1] 307717 0
01/09/2020
Approval date [1] 307717 0
26/10/2020
Ethics approval number [1] 307717 0
HEC20402

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

Contacts
Principal investigator
Name 108254 0
Dr Matthew Cotchett
Address 108254 0
La Trobe University
Kingsbury Drive
Bundoora, Victoria, 3086
Country 108254 0
Australia
Phone 108254 0
+61 3 5444 7213
Fax 108254 0
Email 108254 0
[email protected]
Contact person for public queries
Name 108255 0
Matthew Cotchett
Address 108255 0
La Trobe University
Kingsbury Drive
Bundoora, Victoria, 3086
Country 108255 0
Australia
Phone 108255 0
+61 3 5444 7213
Fax 108255 0
Email 108255 0
[email protected]
Contact person for scientific queries
Name 108256 0
Matthew Cotchett
Address 108256 0
La Trobe University
Kingsbury Drive
Bundoora, Victoria, 3086
Country 108256 0
Australia
Phone 108256 0
+61 3 5444 7213
Fax 108256 0
Email 108256 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?
All the individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Case by case basis at the discretion of the primary sponsor
Available for what types of analyses?
Only to achieve the aims in the approved proposal and for meta-analyses
How or where can data be obtained?
Access subject to approvals by the Principal Investigator.

The Principal Investigator can be contacted via 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.