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Trial registered on ANZCTR


Registration number
ACTRN12615001266550
Ethics application status
Approved
Date submitted
12/11/2015
Date registered
19/11/2015
Date last updated
14/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Corticosteroid injections compared to foot orthoses for plantar heel pain
Scientific title
For adults with plantar heel pain, is an ultrasound-guided corticosteroid injection more effective than foot orthoses for reducing pain and increasing function.
Secondary ID [1] 287781 0
Nil known
Universal Trial Number (UTN)
U1111-1176-1291
Trial acronym
SOOTHE Heel Pain Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plantar heel pain 296670 0
Plantar fasciitis 296753 0
Condition category
Condition code
Musculoskeletal 296892 296892 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single corticosteroid injection.

1 mL betamethasone (Celestone Chondrose) mixed with 1 mL bupivacaine (Marcaine 0.5%) injected perifascially by a radiologist under ultrasound guidance. As this is a single injection, adherence will be monitored by attendance at the appointment with the radiologist, Adverse events associated with this intervention will be documented.

In addition, participants will perform plantar fascia and calf stretches prior to standing each morning, by holding the stretch for a period of 10 seconds, repeated 10 times for each foot/leg (total daily stretch session of approximately 7 to 8 minutes each morning for 12 weeks). Adherence will be monitored by recording the number of days per week the participant has performed their stretches, assessed via questionnaire at each four-weekly timepoint.
Intervention code [1] 293172 0
Treatment: Drugs
Comparator / control treatment
Prefabricated foot orthoses (Formthotics manufactured by Footscience Christchurch, New Zealand).

The foot orthoses will be a full-length arch contouring device, manufactured from a single-density polyethylene closed cell foam that will support the arch of the foot. Participants will be advised to use the foot orthoses in their footwear for as much time as they can during the day, for the 12 weeks of the trial. Adherence will be monitored by recording the average days per week, plus the average number of hours per day the participant has worn the foot orthoses, assessed via questionnaire at each four-weekly timepoint. Adverse events associated with this intervention will be documented.

In addition, participants will perform plantar fascia and calf stretches prior to standing each morning, by holding the stretch for a period of 10 seconds, repeated 10 times for each foot/leg (total daily stretch session of approximately 7 to 8 minutes each morning for 12 weeks). Adherence will be monitored by recording the number of days per week the participant has performed their stretches, assessed via questionnaire at each four-weekly timepoint.
Control group
Active

Outcomes
Primary outcome [1] 296498 0
The foot pain domain of the Foot Health Status Questionnaire
Timepoint [1] 296498 0
Baseline, 4, 8 and 12 weeks
Secondary outcome [1] 318614 0
Severity of ‘first step’ pain after rising in the morning on a 100mm visual analogue scale (VAS)

Timepoint [1] 318614 0
Baseline, 4, 8 and 12 weeks
Secondary outcome [2] 318615 0
Severity of 'average' pain today on a 100mm visual analogue scale (VAS)
Timepoint [2] 318615 0
Baseline, 4, 8 and 12 weeks
Secondary outcome [3] 318616 0
The foot function domain of the FHSQ
Timepoint [3] 318616 0
Baseline, 4, 8 and 12 weeks
Secondary outcome [4] 318618 0
Plantar fascia thickness measured sonographically
Timepoint [4] 318618 0
Baseline, 4 and 12 weeks
Secondary outcome [5] 318619 0
Health-related quality of life assessed by the Short Form 36 (SF-36)
Timepoint [5] 318619 0
Baseline, 4, 8 and 12 weeks
Secondary outcome [6] 318620 0
The 7-day Physical Activity Recall Questionnaire
Timepoint [6] 318620 0
Baseline, 4, 8 and 12 weeks
Secondary outcome [7] 318621 0
Fear-avoidance beliefs measured using the Fear-avoidance Components Scale (FACS)
Timepoint [7] 318621 0
Baseline, 4, 8 and 12 weeks
Secondary outcome [8] 318622 0
Days of work lost measured by self-report questionnaire at each four-weekly time-point
Timepoint [8] 318622 0
Baseline, 4, 8 and 12 weeks
Secondary outcome [9] 318623 0
Sessions of sport or exercise lost measured by self-report questionnaire at each four-weekly time-point.
Timepoint [9] 318623 0
Baseline, 4, 8 and 12 weeks
Secondary outcome [10] 318624 0
Co-interventions used for plantar heel pain measured by self-report questionnaire at each four-weekly time-point.
Timepoint [10] 318624 0
Baseline, 4, 8 and 12 weeks
Secondary outcome [11] 318809 0
Health-related quality of life assessed by the EuroQol (EQ-5D)
Timepoint [11] 318809 0
Baseline, 4, 8 and 12 weeks
Secondary outcome [12] 318819 0
Global perceived rating of change measured with a 15-point Likert scale
Timepoint [12] 318819 0
4, 8 and 12 weeks

Eligibility
Key inclusion criteria
(i) Aged 18 years and over
(ii) Have a clinical diagnosis of PHP in accordance with the clinical practice guidelines linked to the International Classification of Function, Disability and Health from the Orthopaedic Section of the American Physical Therapy Association, which includes:
a. Pain the plantar medial heel region that is aggravated by weightbearing activities or worse in the morning and/or after a period of rest
b. Pain upon palpation of them medial calcaneal tubercle
(iii) A duration of PHP for at least 4 weeks
(iv) Report their average pain over the last seven days as at least 30 mm on a 100 mm visual analogue scale
(v) Be willing to regularly wear foot orthoses for the duration of the trial
(vi) Be willing and have no contraindications to receive a corticosteroid injection in the plantar heel
(vii) Be willing not to implement any other forms of treatment during the trial (with the exception of paracetamol 4g/day)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) Unable to understand the English language
(ii) Unable to walk household distances unaided
(iii) Have received treatment for PHP in the last four weeks
(iv) Have received a corticosteroid injection in the previous six months
(v) Have a history of surgery to the heel
(vi) Have a systemic medical condition such as a connective tissue disease, degenerative neurological disorder or inflammatory disorder
(vii) Unwilling to wear footwear that can accommodate foot orthoses
(viii) Have regularly worn foot orthoses within the previous six 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 allocated to groups using an interactive voice response telephone service provided by the National Health and Medical Research Council (NHMRC) Clinical Trials Centre at the University of Sydney, New South Wales, Australia. A secondary investigator who is not involved with any other part of the trial will advise participants of their allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence will be generated by an interactive voice response telephone service provided by the National Health and Medical Research Council (NHMRC) Clinical Trials Centre at the University of Sydney, New South Wales, Australia. Permuted block randomisation with uneven random block sizes will be undertaken. Minimisation will be undertaken by stratifying participants based on their sex, BMI and the duration of symptoms.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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
The sample size has been calculated a priori based on being able to detect a minimal important difference of 13 points on the pain domain of the Foot Health Status Questionnaire, the primary outcome measure. Using a standard deviation derived from previous research of 21, a power of 0.8, alpha level of 0.05 and a conservative drop out of 10%, a sample size of 46 participants per group will be required to provide sufficient power. To allow for unforeseen circumstances we aim to recruit a total of 100 participants who will be randomised to one of two groups (i.e. approximately 50 participants per group)

Where appropriate continuous data will be analysed using parametric statistical tests. To achieve this, data will be checked for normality. If data is not normally distributed, it will be transformed if appropriate, otherwise non-parametric tests will be conducted. If normally distributed, primary and secondary outcomes will be compared using the linear regression approach to analysis of covariance (ANCOVA) with baseline severity included as a covariate.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/04/2016
Actual
6/05/2016
Date of last participant enrolment
Anticipated
1/03/2018
Actual
6/06/2017
Date of last data collection
Anticipated
Actual
6/11/2017
Sample size
Target
100
Accrual to date
Final
103
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 292315 0
University
Name [1] 292315 0
La Trobe University
Country [1] 292315 0
Australia
Primary sponsor type
Individual
Name
Glen Whittaker
Address
Discipline of Podiatry
School of Allied Health
La Trobe University
Bundoora,
Victoria 3086
Country
Australia
Secondary sponsor category [1] 290993 0
None
Name [1] 290993 0
Address [1] 290993 0
Country [1] 290993 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293787 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 293787 0
La Trobe University
Bundoora,
Victoria 3086
Ethics committee country [1] 293787 0
Australia
Date submitted for ethics approval [1] 293787 0
20/11/2015
Approval date [1] 293787 0
13/01/2016
Ethics approval number [1] 293787 0
15-120

Summary
Brief summary
Our primary aim is to compare the effectiveness of ultrasound-guided corticosteroid injections to foot orthoses (shoe insoles) for individuals with plantar heel pain, using an assessor-blinded randomised trial. Our hypothesis is that corticosteroid injections will be more effective in the short-term (0-4 weeks), while foot orthoses will be more effective in the longer term (5-12 weeks).
Our secondary aims are to compare the effectiveness of corticosteroid injections to foot orthoses on: foot function; general health; plantar fascia thickness; work, sport and recreation; and fear-avoidance beliefs.
Trial website
www.heelpaintrial.com
Trial related presentations / publications
Whittaker, G. A., Munteanu, S. E., Menz, H. B., Elzarka, A., & Landorf, K. B. (2017). Corticosteroid injections compared to foot orthoses for plantar heel pain: protocol for the SOOTHE heel pain randomised trial. Contemporary Clinical Trials Communications, 5, 1–11. doi: 10.1016/j.conctc.2016.11.003.
Public notes
Attachments [1] 1626 1626 0 0
/AnzctrAttachments/369563-1-s2.0-S2451865416300357-main.pdf (Protocol)

Contacts
Principal investigator
Name 61310 0
Mr Glen Whittaker
Address 61310 0
Discipline of Podiatry
School of Allied Health
La Trobe University
Bundoora, Victoria, 3086
Country 61310 0
Australia
Phone 61310 0
+61 3 9479 5785
Fax 61310 0
+61 3 9479 5415
Email 61310 0
g.whittaker@latrobe.edu.au
Contact person for public queries
Name 61311 0
Glen Whittaker
Address 61311 0
Discipline of Podiatry
School of Allied Health
La Trobe University
Bundoora, Victoria, 3086
Country 61311 0
Australia
Phone 61311 0
+61 3 9479 5785
Fax 61311 0
+61 3 9479 5415
Email 61311 0
g.whittaker@latrobe.edu.au
Contact person for scientific queries
Name 61312 0
Glen Whittaker
Address 61312 0
Discipline of Podiatry
School of Allied Health
La Trobe University
Bundoora, Victoria, 3086
Country 61312 0
Australia
Phone 61312 0
+61 3 9479 5785
Fax 61312 0
+61 3 9479 5415
Email 61312 0
g.whittaker@latrobe.edu.au

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseCorticosteroid injections compared to foot orthoses for plantar heel pain: protocol for the SOOTHE heel pain randomised trial.2017https://dx.doi.org/10.1016/j.conctc.2016.11.003
N.B. These documents automatically identified may not have been verified by the study sponsor.