Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000829213
Ethics application status
Approved
Date submitted
11/09/2009
Date registered
22/09/2009
Date last updated
4/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of customised foot orthoses in the treatment of Achilles tendinopathy
Scientific title
Efficacy of customised foot orthoses in improving pain, function and activity in people with Achilles tendinopathy undergoing an eccentric calf muscle exercise program
Secondary ID [1] 259814 0
New secondary ID. Please modify.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Achilles tendinopathy 243702 0
Condition category
Condition code
Musculoskeletal 239965 239965 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Custom foot orthoses (made from semi-rigid polypropylene) worn for the study duration (12 months) combined with a 12 week calf muscle eccentric exercise program (3 sets of 15 repetitions performed with knee straight then flexed, twice daily, seven days per week at home)
Intervention code [1] 241240 0
Treatment: Devices
Comparator / control treatment
Sham foot orthoses (made from soft foam) worn for the study duration (12 months)combined with a 12 week calf muscle eccentric exercise program (3 sets of 15 repetitions performed with knee straight then flexed, twice daily, seven days per week at home). The eccentric exercise program is identical in the intervention and control groups.
Control group
Placebo

Outcomes
Primary outcome [1] 240892 0
Total score of the Victorian Institute of Sport Assessment - Achilles (VISA-A questionnaire) which is made up of pain, function and activity sub-domains
Timepoint [1] 240892 0
baseline, then 1, 3, 6 and 12 months
Secondary outcome [1] 257570 0
Participant perception of treatment effect: The perception of treatment effect (5-point Likert scale: marked worsening, moderate worsening, same, moderate improvement, and marked improvement). Responses will then be dichotomised according to success, where 'success' is defined as marked or moderate improvement on this scale
Timepoint [1] 257570 0
1, 3, 6 and 12 months
Secondary outcome [2] 257571 0
Comfort of the interventions (customised foot orthoses and sham foot orthoses): The comfort of the customised foot orthoses and sham foot orthoses will be assessed using a 150 mm visual analogue scale with the left end of the scale (0 mm) labelled not comfortable at all and the right end of the scale (150 mm) labelled most comfortable imaginable. Participants will be asked to indicate the comfort of their shoe inserts compared to when they are not in their shoes, the further the right the more comfortable the shoe inserts.
Timepoint [2] 257571 0
baseline, then 1, 3, 6 and 12 months
Secondary outcome [3] 257572 0
Co-interventions: The number of participants who consume rescue medication (i.e., paracetamol) and mean consumption of rescue medication to relieve pain at the Achilles tendon(s) (mean grams of paracetamol/participant/month] will be assessed using a medications diary that participants will self-complete. A questionnaire regarding the use of other treatments to relieve pain at the Achilles tendon(s) by participants will be completed . Other treatments will include oral non-steroidal anti-inflammatory medication, visits to health-care practitioners (general practitioners, specialists and allied health professionals such as physiotherapists and podiatrists), changes to foot orthoses or wedging, massage, acupuncture, complementary medicine (such as osteopaths and naturopaths), topical medicaments (such as rubefacients or topical non-steroidal anti-inflammatory medication), taping or bracing. Participants will also be questioned to determine if they have changed their footwear they normally wear (worn for everyday or sporting activities) to accommodate their foot orthoses.
Timepoint [3] 257572 0
1, 3, 6 and 12 months
Secondary outcome [4] 257573 0
Frequency and severity of adverse events: The frequency (number of participants affected and number of cases), types (including rubbing or blistering of the feet or ankles, pain in the feet, lower limbs or other part(s) of the body) and severity (mild, moderate or severe as rated by the participant) of adverse events in each intervention group during the trial will be recorded using a questionnaire that participants will complete at 1, 3, 6 and 12 months. An open-response type format will also be available for participant responses.
Timepoint [4] 257573 0
1, 3, 6 and 12 months
Secondary outcome [5] 257574 0
Level of physical activity in the previous week: The level of physical activity in the previous week will be evaluated with a questionnaire, the 7-day Recall Physical Activity Questionnaire . This questionnaire records all physical activities (work as well as leisure and household activities) during the preceding week. The questionnaire involves quantifying the time (hours) spent in moderate, hard and very hard activities during the preceding 7 days. The time (hours) spent in each activity is then multiplied by its metabolic equivalent (MET) where 1 MET is the energy expended by a person while sitting at rest (equal to 1 kilocalorie per kilogram per hour). The total calories (kilocalories) of energy expended per kilogram of body weight can then be calculated. Kilocalories per day (for the participant) can then be derived by multiplying the kilocalories per kilogram by the participant's body weight and dividing this by 7.
Timepoint [5] 257574 0
baseline, then 1, 3, 6 and 12 months
Secondary outcome [6] 257575 0
Health-related quality of life: The Short-Form-36 (Version two) questionnaire will be used to assess health-related quality of life.
Timepoint [6] 257575 0
baseline, then 1, 3, 6 and 12 months

Eligibility
Key inclusion criteria
To be included in the study, participants must meet the following inclusion criteria:
(i) Aged 18 to 55 years;
(ii) Have symptoms in the Achilles tendon of one or both lower limbs for at least 3 months duration;
(iii) Be literate in English and able to complete the Victorian Institute of Sport - Achilles (VISA-A) questionnaire;
(iv) Score less than 80 on the VISA-A questionnaire;
(v) Regularly use footwear that can accommodate customised foot orthoses. This is defined as using footwear that can accommo date foot orthoses for at least 90% of the time during weightbearing activities;
(vi) Be willing to not receive any physical therapy on the involved Achilles tendon(s) or trial of foot orthoses or bracing (other than those allocated in the current study) during the study period.

Achilles tendinopathy will be diagnosed from a clinical assessment as well as from a musculoskeletal ultrasound assessment using the following criteria:
(i) Insidious onset of pain in the Achilles tendon region that is aggravated by weightbearing activities and worse in the morning, and/or during the initial stages of weightbearing activities; (ii) Pain and swelling located 2-6 cm proximal to the Achilles tendon insertion (as described by patient and palpated by the investigator); (iii) Musculoskeletal ultrasound imaging of the Achilles tendon showing local thickening (anterior-posterior) and/or irregular fibre orientation and/or irregular tendon structure with hypoechoic areas an d/or vascularisation within the mid-portion of the Achilles tendon.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for participants in this study will be:
(i) Previous Achilles tendon surgery in the symptomatic lower limb;
(ii) Previous Achilles tendon rupture in the symptomatic lower limb;
(iii) Previous lower limb trauma that has caused structural imbalance (e.g. ankle fracture);
(iv) Osseous abnormality of the ankle (e.g. anterior or posterior tibio-talar osteophytes);
(v) Inflammatory arthritis (e.g. ankylosing spondylitis);
(vi) Metabolic or endocrine disorders (e.g. type I or II diabetes);
(vii) Neurological disorders (e.g. Charcot-Marie-Tooth disease);
(viii) Previous breast cancer and/or use of oestrogen inhibitors;
(ix) Treatment with foot orthoses, heel lifts or eccentric calf muscle exercises within the previous 3 months;
(x) Disorders of the Achilles tendon that are not mid-portion tendinopathy (such as paratendinitis and insertional Achilles tendon disorders);
(xi) Taken fluoroquinolones within previous 2 years;
(xii) Injection of local anaesthetic or cortisone or other pharmaceutical agents into the Achilles tendon or surrounding area within the previous 3 months;
(xiii) Injury or pathology of the foot, knee, hip and/or back or any condition that, in the opinion of the investigators, may interfere with participation in the study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation to either of the intervention groups will be achieved using a computer-generated random number sequence. The allocation sequence will be generated and held by an external person not directly involved in the trial. Concealment of the allocation sequence will be ensured as each participant’s allocation will be contained in a sealed opaque envelope. Envelopes will be made opaque by using a sheet of aluminium foil inside the envelope. In addition, a system using carbon paper will be employed so the details (name of participant and date of recruitment) are transferred from the outside of the envelope to the paper inside the envelope containing the allocation prior to opening the seal.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation to either of the intervention groups will be achieved using a computer-generated random number sequence. The allocation sequence will be generated and held by an external person not directly involved in the trial.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2009
Actual
28/07/2009
Date of last participant enrolment
Anticipated
Actual
5/06/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243720 0
Commercial sector/Industry
Name [1] 243720 0
Prescription Foot Orthotic Laboratory Association (PFOLA)
Country [1] 243720 0
Canada
Primary sponsor type
Individual
Name
Shannon Munteanu
Address
La Trobe University, Bundoora, Victoria 3086
Country
Australia
Secondary sponsor category [1] 237083 0
None
Name [1] 237083 0
Address [1] 237083 0
Country [1] 237083 0
Other collaborator category [1] 854 0
Individual
Name [1] 854 0
Karl Landorf
Address [1] 854 0
La Trobe University, Bundoora, Victoria 3086
Country [1] 854 0
Australia
Other collaborator category [2] 855 0
Individual
Name [2] 855 0
Hylton Menz
Address [2] 855 0
La Trobe University, Bundoora, Victoria 3086
Country [2] 855 0
Australia
Other collaborator category [3] 856 0
Individual
Name [3] 856 0
Tania Pizzari
Address [3] 856 0
La Trobe University, Bundoora, Victoria 3086
Country [3] 856 0
Australia
Other collaborator category [4] 857 0
Individual
Name [4] 857 0
Jill Cook
Address [4] 857 0
Deakin University, Burwood, Victoria 3125
Country [4] 857 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243850 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 243850 0
Ethics committee country [1] 243850 0
Australia
Date submitted for ethics approval [1] 243850 0
Approval date [1] 243850 0
06/11/2008
Ethics approval number [1] 243850 0
1/08/0114

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

Contacts
Principal investigator
Name 30165 0
Dr Shannon Munteanu
Address 30165 0
La Trobe University, Bundoora, Victoria 3086
Country 30165 0
Australia
Phone 30165 0
+61-3-94795866
Fax 30165 0
Email 30165 0
[email protected]
Contact person for public queries
Name 13412 0
Shannon Munteanu
Address 13412 0
La Trobe University, Bundoora, Victoria 3086
Country 13412 0
Australia
Phone 13412 0
+61 3 9479 5866
Fax 13412 0
+61 3 9479 5784
Email 13412 0
[email protected]
Contact person for scientific queries
Name 4340 0
Shannon Munteanu
Address 4340 0
La Trobe University, Bundoora, Victoria 3086
Country 4340 0
Australia
Phone 4340 0
+61 3 9479 5866
Fax 4340 0
+61 3 9479 5784
Email 4340 0
[email protected]

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
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Documents added automatically
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