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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00118521
Registration number
NCT00118521
Ethics application status
Date submitted
1/07/2005
Date registered
11/07/2005
Date last updated
19/12/2013
Titles & IDs
Public title
A Clinical Study in the Use of Orthotics in Treating Pain in the Front of the Knee
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Scientific title
Foot Orthotics in the Treatment of Patellofemoral Pain Syndrome: A Randomised Clinical Trial in Primary Care
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Secondary ID [1]
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NHMRC#301037
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Secondary ID [2]
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2003001023NHMRC
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Patellofemoral Pain Syndrome
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Worst and Usual Pain Visual Analogue Scale
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Assessment method [1]
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Timepoint [1]
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Primary outcome [2]
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Functional Index Questionnaire
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Assessment method [2]
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Timepoint [2]
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Primary outcome [3]
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Anterior Knee Pain Scale
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Assessment method [3]
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Timepoint [3]
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Primary outcome [4]
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Patient Perceived Treatment Effect score
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Assessment method [4]
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Timepoint [4]
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Primary outcome [5]
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Perceived Global Effect 5 Point Scale
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Timepoint [5]
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Secondary outcome [1]
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Physical activity level in previous week
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [2]
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Step up, step down and squat tests
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Assessment method [2]
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Timepoint [2]
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Secondary outcome [3]
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Lower Extremity Functional Scale
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Assessment method [3]
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Timepoint [3]
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Secondary outcome [4]
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McGill Pain Questionnaire
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Assessment method [4]
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Timepoint [4]
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Secondary outcome [5]
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SF-36 Health Survey
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Assessment method [5]
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Timepoint [5]
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Secondary outcome [6]
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Hospital Anxiety and Depression Scale
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Assessment method [6]
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Timepoint [6]
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Secondary outcome [7]
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Patient Specific Functional Scale
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Assessment method [7]
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Timepoint [7]
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Secondary outcome [8]
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Pressure pain threshold
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Assessment method [8]
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Timepoint [8]
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Eligibility
Key inclusion criteria
* Clinical diagnosis of patellofemoral pain syndrome (non traumatic origin) of at least 6 weeks duration
* Pain with at least 2 of the following activities: stair walking, jogging/running, squatting, hopping/jumping, kneeling or prolonged sitting
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Minimum age
18
Years
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Maximum age
40
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* Concomitant injury or pathology of other knee joint structures, eg. meniscal, ligamentous etc.
* Pain in or referred from the lumbar spine and hip
* History of knee fractures, patellar dislocation/subluxation with a positive apprehension test
* Prior physiotherapy treatment (including patellar taping) within the past 12 months
* History of allergic reaction to adhesive tape
* Current or previous foot orthotic use
* Any condition of the foot that precludes orthotic therapy
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2004
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2007
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Musculoskeletal Pain & Injury Research Unit, Division of Physiotherapy, The University of Queensland - Brisbane
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Recruitment postcode(s) [1]
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4072 - Brisbane
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Funding & Sponsors
Primary sponsor type
Other
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Name
The University of Queensland
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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National Health and Medical Research Council, Australia
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
Musculoskeletal conditions account for the third leading cause of health systems expenditure in Australia. Patellofemoral pain syndrome or pain about the knee cap is such a condition often treated in primary care. Both the individual and community are affected by this condition with an estimated 1 in 4 sufferers having problems and pain up to 20 years after first being afflicted. Importantly, it interferes with activities such as walking, jogging, gym classes and aerobics, which are often prescribed to prevent serious conditions of the heart, diabetes and obesity. Hence, it negatively impacts the health and well being of our nation. Two popular treatment options that are commonly prescribed for the management of patellofemoral pain syndrome are physiotherapy and foot orthotics. To date, there is some evidence supporting physiotherapy, especially current best practice methods, such as a combined program of therapeutic exercise, manual therapy and kneecap taping. There is a lack of evidence for the use of orthotics in treating patellofemoral pain syndrome. This project will conduct a randomised clinical trial to evaluate the relative benefits of orthotics as the sole treatment of patellofemoral pain syndrome and also when combined with physiotherapy. Factors associated with predicting the results of orthotic therapy will be studied to see if there are any tests that a health care practitioner can perform to provide information early on in a consultation regarding possible treatment outcomes. A cost-benefit analysis will also be conducted to calculate the relative economic merits of the treatments. A tangible outcome of this project will be the development of clinical guidelines for the most effective method of treating patellofemoral pain syndrome in primary health care.
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Trial website
https://clinicaltrials.gov/study/NCT00118521
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Trial related presentations / publications
Collins NJ, Bierma-Zeinstra SM, Crossley KM, van Linschoten RL, Vicenzino B, van Middelkoop M. Prognostic factors for patellofemoral pain: a multicentre observational analysis. Br J Sports Med. 2013 Mar;47(4):227-33. doi: 10.1136/bjsports-2012-091696. Epub 2012 Dec 13. Collins N, Crossley K, Beller E, Darnell R, McPoil T, Vicenzino B. Foot orthoses and physiotherapy in the treatment of patellofemoral pain syndrome: randomised clinical trial. Br J Sports Med. 2009 Mar;43(3):169-71. doi: 10.1136/bmj.a1735. Collins N, Crossley K, Beller E, Darnell R, McPoil T, Vicenzino B. Foot orthoses and physiotherapy in the treatment of patellofemoral pain syndrome: randomised clinical trial. BMJ. 2008 Oct 24;337:a1735. doi: 10.1136/bmj.a1735. Vicenzino B, Collins N, Crossley K, Beller E, Darnell R, McPoil T. Foot orthoses and physiotherapy in the treatment of patellofemoral pain syndrome: a randomised clinical trial. BMC Musculoskelet Disord. 2008 Feb 27;9:27. doi: 10.1186/1471-2474-9-27.
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Public notes
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Contacts
Principal investigator
Name
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Bill Vicenzino, PhD
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Address
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The University of Queensland
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Email
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Contact person for public queries
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Contact person for scientific queries
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
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00118521
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