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Trial registered on ANZCTR


Registration number
ACTRN12609000696291
Ethics application status
Approved
Date submitted
10/08/2009
Date registered
12/08/2009
Date last updated
25/08/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial assessing the impact of footwear, heel raises and orthoses on pain relief in children with calcaneal aphophysitis ("Sever's")
Scientific title
For children in pain with Calcaneal Apophysitis, how do footwear, heel raises or pre-fabricated orthoses impact pain relief.
Secondary ID [1] 927 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Calcaneal apophysitis 237271 0
Condition category
Condition code
Musculoskeletal 239593 239593 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Shoe and heel raises - Heel raise with new footwear - Heel raise with current footwear Heel raises are made from high density ethylene vinyl acetate (EVA). Heel raises are to be worn for the period of the trial/pain. Removal of the device at a point of pain free. The children are to continue with their every day activities whilst wearing the treatment device. The footwear prescription/replacement intervention involves a shoe with a firm heel counter, dual density EVA midsole, rear foot control and an arch support. The intervention period for thi interventions is 2 months with followup period of 12 months.
Intervention code [1] 236951 0
Treatment: Devices
Comparator / control treatment
Shoe and orthoses - Pre-fabricated orthoses and new footwear - Pre-fabricated orthoses and current footwear The prefabricated orthoses (intervention is a Firm prefabricated device. The orthotics is a high density EVA device that limits pronation.The orthoses will be covered in a 2mm blown EVA cover which is designed to increase shock absorption . The orthoses is to be worn for the period of the trial/pain. The children are to continue their everyday activity whilst wearing the treatment devices. Wearing in advice is to be provided to the participants. The footwear prescription/replacement intervention involves a shoe with a firm heel counter, dual density EVA midsole, rear foot control and an arch support.
The intervention period for this intervention/comparator is 2 months with a followup period of 12 months
Control group
Active

Outcomes
Primary outcome [1] 238400 0
The Oxford Ankle Foot Questionnaire is taken from parent and child perspectives. This scale contains domains of:
- physical, school and play
Timepoint [1] 238400 0
At initial randomisation, 1 month, 2 month and 6 and 12 month time points
Secondary outcome [1] 244871 0
The Faces Pain Scale
7 point verbal rating scale of pain severity at rest, on palpation, during activity and after activity (post 2 hours)
Timepoint [1] 244871 0
At initial randomization, 1 month and 2 month time points.
The faces pain scale was not completed at the 6 and 12 month point. The 6 and 12 month followup is via the phone so the use of this tool was not appropriate and therefore not undertaken.

Eligibility
Key inclusion criteria
- Children between the ages of eight to twelve years.
- Subjective report of pain located on the calcaneal apophysis (ie. posterior aspect of heel) with pain on palpation
Minimum age
8 Years
Maximum age
14 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Recently (last 12 months) diagnosed fracture or tumour of the foot or leg
- Diagnosed infective, reactive or rheumatoid arthritis

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)
The trial is to be conducted in a Community Health Service. Patients with the diagnosis of Calcaneal Apophysitis are invited to participate. Verbal and written consent will be contained. After accepting the invitation, the patients will be evaluated and assigned to the treatment groups according to the randomization. Allocation will be concealed using opaque and sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuated block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

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)

Funding & Sponsors
Funding source category [1] 237350 0
Self funded/Unfunded
Name [1] 237350 0
Address [1] 237350 0
Country [1] 237350 0
Primary sponsor type
Individual
Name
Dr Terry Haines
Address
Allied Health Clinical Research Unit, Kingston Centre, Kingston Rd, Cheltenham, Victoria, 3192
Country
Australia
Secondary sponsor category [1] 236914 0
Individual
Name [1] 236914 0
Alicia James
Address [1] 236914 0
Peninsula Health Service
12-32 Hastings Rd Frankston,
Victoria 3199
Country [1] 236914 0
Australia
Other collaborator category [1] 794 0
Individual
Name [1] 794 0
Cylie Williams
Address [1] 794 0
Peninsula Health Service
12-32 Hastings Rd Frankston,
Victoria 3199
Country [1] 794 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239478 0
Southern Health Human Research Ethics Commitee (HREC) B
Ethics committee address [1] 239478 0
Research Support Unit
Research Directorate
Level 4, Main Block,
Monash Medical Centre
246 Clayton Road
CLAYTON VIC 3168
Ethics committee country [1] 239478 0
Australia
Date submitted for ethics approval [1] 239478 0
02/09/2009
Approval date [1] 239478 0
05/11/2010
Ethics approval number [1] 239478 0
Ethics committee name [2] 291567 0
Peninsula Health Ethics Commitee
Ethics committee address [2] 291567 0
2 Hastings Rd Frankston
Ethics committee country [2] 291567 0
Date submitted for ethics approval [2] 291567 0
Approval date [2] 291567 0
22/03/2010
Ethics approval number [2] 291567 0
HREC/09/PH/65

Summary
Brief summary
This study seeks to establish a clinically evidenced base treatment options for the relief of pain associated with calcaneal apophysitis in children between the ages of eight and fourteen years of age.

The heel bone is located at the most posterior plantar aspect of the foot. The Achilles tendon attaches into the posterior, lower aspect of the calcaneus and near this attachment is the calcaneus secondary growth centre. This is the site of pain experienced during Calcaneal apophysitsis.

Treatment within this study includes two levels of shoe orthoses. A heel raise or prefabricated orthoses. Both of these interventions are widely available, mutually exclusive treatment approaches that are relatively low in cost. The footwear prescription/replacement intervention involves a shoe with a firm heel counter, dual density EVA midsole, and rear foot control. The alternate condition in this factor is “no footwear prescription/replacement” with the participant wearing their own footwear.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29910 0
Ms Alicia James
Address 29910 0
Peninsula Health 12-32 Hastings Rd Frankston 3199 Vic
Country 29910 0
Australia
Phone 29910 0
+61 3 97848361
Fax 29910 0
Email 29910 0
aliciajames@phnc.vic.gov.au
Contact person for public queries
Name 13157 0
Ms Alicia James
Address 13157 0
Peninsula Health Service
12-32 Hastings Rd Frankston 3199 Vic
Country 13157 0
Australia
Phone 13157 0
+61 3 97848361
Fax 13157 0
+61 3 9784 7053
Email 13157 0
aliciajames@phcn.vic.gov.au
Contact person for scientific queries
Name 4085 0
A/Prof Terry Haines
Address 4085 0
Allied Health Research Unit
Kingston Centre
Cnr Warrigal and Kingston Rds
Cheltenham, Victoria, 3192
Country 4085 0
Australia
Phone 4085 0
+ 61 3 9265 1774
Fax 4085 0
+61 3 9265 1577
Email 4085 0
Terrence.haines@southernhealth.org.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