Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000492954
Ethics application status
Approved
Date submitted
10/05/2011
Date registered
11/05/2011
Date last updated
11/05/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The use of in-shoe foot orthoses in the short-term treatment of anterior knee pain
Scientific title
In patients with anterior knee pain, are prefabricated in-shoe foot orthoses as good or better than a wait-and-see control group for physiological adaptation and relief of symptoms in the short-term?
Secondary ID [1] 262145 0
nil
Universal Trial Number (UTN)
U1111-1121-2668
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior knee pain 265824 0
Condition category
Condition code
Musculoskeletal 265979 265979 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prefabricated, commercially available, full length in-shoe orthoses fabricated from ethylene-vinyl acetate. Participants are given the choice of 3 different hardnesses (hard, medium and soft) are fitted with the most comfortable. Orthoses are worn as much as possible, in all pairs of shoes for 6 weeks
Intervention code [1] 264559 0
Treatment: Devices
Comparator / control treatment
wait-and-see policy (i.e. nothing)
Control group
Active

Outcomes
Primary outcome [1] 266723 0
Patient perceived improvement on a 6-point Global Improvement scale: completely recovered, much improved, improved, no change, worse and much worse. Completely recovered and much improved are considered successful treatment
Timepoint [1] 266723 0
6 weeks
Primary outcome [2] 266724 0
Neuromotor changes of gluteus medius, biceps femoris, vastus lateralis, vastus medialis obliquus, rectus femoris, tibialis anterior, soleus and medial gastrocnemius. Measured by comparing electromyography signals recorded while jogging wearing the shoe with those recorded when jogging wearing the orthoses.
Timepoint [2] 266724 0
Baseline and at 6-weeks after baseline
Secondary outcome [1] 276257 0
100 mm visual analogue scale for usual pain over the preceeding week. Changes > 20mm considered clinically meaningful
Timepoint [1] 276257 0
Baseline and 6-weeks after baseline
Secondary outcome [2] 276258 0
100 mm visual analogue scale for worst pain over the preceeding week. Changes > 20mm considered clinically meaningful
Timepoint [2] 276258 0
Baseline and 6-weeks after baseline
Secondary outcome [3] 276261 0
Kujala Patellofemoral Score > 10 points change from baseline to follow-up
Timepoint [3] 276261 0
Baseline and 6-weeks after baseline
Secondary outcome [4] 276264 0
Patient Specific Functional Scale >2 points change is considered clinically meaningful
Timepoint [4] 276264 0
Baseline and 6-weeks after baseline

Eligibility
Key inclusion criteria
Patients complain of anterior or retropatella pain of greater than 6-weeks duration aggravated by 2 of the following activities: running, stair or hill climbing, hopping, jumping, squatting, kneeling or sitting for long periods of time. Pain on palpation of the patella facet or on deep squat.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) concomitant pain or injury in the hip, pelvis or lumbar spine;
(2) damage to any knee structures or indications of patella tendinosis;
(3) chronic patella instability
(4) knee effusion;
(5) any foot conditions that would preclude the use of orthoses;
(6) the use of physiotherapy treatment for knee pain or foot orthoses in the previous 3 years; or
(7) previous lower limb surgery.

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)
Potential participants were screened for all major inclusion and exclusion criteria via email or phone followed by a physical screening by 2 physiotherapists to confirm a diagnosis of anterior knee pain.
On giving informed consent, participants were allocated to the treatment or intervention group based on computerised randomisation program. An automated data file set up by a third party off-site was used to preserve allocation concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation sequence (Math.random in JavaScript)
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
16/09/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4000 0
2617
Recruitment postcode(s) [2] 4001 0
2602
Recruitment postcode(s) [3] 4002 0
2615
Recruitment postcode(s) [4] 4003 0
2616
Recruitment postcode(s) [5] 4004 0
2600
Recruitment postcode(s) [6] 4005 0
2603
Recruitment postcode(s) [7] 4006 0
2611
Recruitment postcode(s) [8] 4007 0
2900

Funding & Sponsors
Funding source category [1] 265037 0
Government body
Name [1] 265037 0
Australian Research Council
Country [1] 265037 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
St Lucia
Brisbane QLD 4072
Country
Australia
Secondary sponsor category [1] 264136 0
Government body
Name [1] 264136 0
Australian Institute of Sport
Address [1] 264136 0
Leverrier Crescent
Bruce, ACT 2617
Country [1] 264136 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 267031 0
the University of Queensland medical research ethics committee
Ethics committee address [1] 267031 0
The Ethics Officer Research and Research Training Division Cumbrae-Stewart Building
The University of Queensland
ST. LUCIA QLD 4072
Ethics committee country [1] 267031 0
Australia
Date submitted for ethics approval [1] 267031 0
24/02/2006
Approval date [1] 267031 0
07/03/2006
Ethics approval number [1] 267031 0
2006000147

Summary
Brief summary
The first purpose of this study is to examine if comfortable in shoe foot orthoses improve the symptoms of anterior knee pain over a short-term period more than a control group who does not receive orthoses. The second purpose is to determine what physiological effect is causing any improvement. We hypothesise orthoses will improve symptoms more than a control and that these improvements are occuring via adaptations in the activity of the lower limb muscles.
Trial website
nil
Trial related presentations / publications
1) Mills K, Blanch P, Vicenzino B. Orthosis comfort and midfoot mobility is more important for immediate lower limb function than hardness or contouring in anterior knee pain. Clinical Biomechanics (under review)
2) Mills K, Blanch P, Dev P, Martin M, Vicenzino B. Greater treatment efficacy of orthoses compared to a wait-and-see approach in people with anterior knee pain and more mobile midfoot. 2nd Patellofemoral Pain International Retreat, 31st August to 1st September 2011, Ghent Belgium (under review)
3) Mills K, Blanch P, Vicenzino B. Foot orthoses' hardness and contouring, not midfoot mobility, influences immediate adaptations in lower limb function in people with anterior knee pain. International Society of Biomechanics, 3rd to 7th July 2011, Brussels Belgium.
4) Mills K, Blanch P, Vicenzino B. Clinical efficacy of comfortable in-shoe foot orthoses has no associated neuromtor adaptations during gait in people with anterior knee pain: a randomised control trial. Footwear Biomechanics Symposium, 29th June to 2nd July 2011, Tübingen Germany
Public notes

Contacts
Principal investigator
Name 32596 0
Address 32596 0
Country 32596 0
Phone 32596 0
Fax 32596 0
Email 32596 0
Contact person for public queries
Name 15843 0
Kathryn Mills
Address 15843 0
c/- Department of Physical Therapies
Australian Institute of Sport
Leverrier Crescent
Bruce, ACT 2616
Country 15843 0
Australia
Phone 15843 0
+61 2 6214 7374
Fax 15843 0
Email 15843 0
[email protected]
Contact person for scientific queries
Name 6771 0
Professor Bill Vicenzino
Address 6771 0
Division of Physiotherapy
School of Health and Rehabilitation Sciences
University of Queensland
St Lucia
QLD 4072
Country 6771 0
Australia
Phone 6771 0
+61 7 3365 2781
Fax 6771 0
Email 6771 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

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