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Trial registered on ANZCTR
Registration number
ACTRN12610000391077
Ethics application status
Approved
Date submitted
23/02/2010
Date registered
14/05/2010
Date last updated
14/05/2010
Type of registration
Retrospectively registered
Titles & IDs
Public title
The effectiveness of foot orthoses for knee pain
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Scientific title
The effect of prefabricated foot orthoses on pain and function in individuals with patellofemoral pain syndrome
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Secondary ID [1]
251773
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nil
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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 (knee pain)
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Condition category
Condition code
Musculoskeletal
257021
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0
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Each participant will be prescribed a pair of prefabricated foot orthoses. They will be required to wear them as often as possible for a period of 12 weeks
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Intervention code [1]
256064
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Treatment: Devices
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Comparator / control treatment
NA - no control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Patient perceived clinical success Likert scale (markedly better, moderately better, same, moderately worse or markedly worse)
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Assessment method [1]
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Timepoint [1]
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6 and 12 weeks after intervention commencement
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Secondary outcome [1]
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Anterior knee pain scale
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Assessment method [1]
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Timepoint [1]
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6 and 12 weeks after intervention commencement
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Secondary outcome [2]
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Lower extremity functional scale
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Assessment method [2]
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Timepoint [2]
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6 and 12 weeks after intervention commencement
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Secondary outcome [3]
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100 mm pain visual analogue scale ancored by 'no pain' and 'worst pain imaginable' for usual and worst pain in the previous week
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Assessment method [3]
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Timepoint [3]
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6 and 12 weeks after intervention commencement
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Secondary outcome [4]
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Change in the number of pain free step downs and single leg rises able to be completed
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Assessment method [4]
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Timepoint [4]
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immediately after intervention commencement and 12 weeks later
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Secondary outcome [5]
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Change in pain and ease of completing a single leg squat on a 5 point Likert scale:
Pain (markedly better, somewhat better, same, somewhat worse, markedly worse)
Ease (markedly easier, somewhat easier, same, somewhat harder, markedly harder)
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Assessment method [5]
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Timepoint [5]
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immediately after intervention and 12 weeks later
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Eligibility
Key inclusion criteria
1. Aged 18 – 35 years old
2. Insidious onset of peripatellar or retropatellar knee pain of at least 6 weeks duration
3. Worst pain in the previous week of at least 30 mm on a 100 mm visual analogue scale
4. Pain provoked by at least two activities from running, walking, hopping, squatting, stair negotiation, kneeling, or prolonged sitting
5. Pain elicited by patellar palpation, patellofemoral joint (PFJ) compression or resisted isometric quadriceps contraction
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Minimum age
18
Years
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Maximum age
35
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Use of foot orthoses in the previous five years
2. Physiotherapy treatment in the previous six months
3. Current use of anti-inflammatory medications
4. Concomitant injury or pain arising from the lumbar spine or hip
5. Knee internal derangement
6. Knee ligament insufficiency
7. Previous knee surgery
8. PFJ instability; or patellar tendinopathy.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All potential participants first give written informed consent. Potential participants are screened by a registered physiotherapist to ensure eligibility. All participant eligible were then administered the same ype of prefabricated foot orthoses
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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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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Date of first participant enrolment
Anticipated
7/08/2008
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Actual
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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
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Musculoskeletal Research Centre
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Address [1]
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La Trobe University Bundoora, Victoria, 3086
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Musculoskeletal Research Centre
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Address
La Trobe University Bundoora, Victoria, 3086
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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La Trobe University's Faculty of Health Sciences Human Ethics Committee
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Ethics committee address [1]
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La Trobe University, Bundoora, Victoria, 3086
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
258605
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Approval date [1]
258605
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06/08/2008
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Ethics approval number [1]
258605
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FHEC08/102
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Summary
Brief summary
Recent research indicates that shoe inserts are effective in treating some individuals with knee pain. However, not all individuals benefit from shoe inserts and research to determine who is most likely to benefit is limited. Therefore, this study is aiming to identify predictors of individuals with knee pain most likely to benefit from shoe inserts.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
30873
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Country
30873
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Christian Barton
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Address
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Musculoskeletal Research Centre
La Trobe University
Bundoora, Victoria
3086
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Country
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Australia
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Phone
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+61 3 9479 5282
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Christian Barton
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Address
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Musculoskeletal Research Centre
La Trobe University
Bundoora, Victoria
3086
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Country
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Australia
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Phone
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+61 3 9479 5282
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Fax
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Email
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[email protected]
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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
No additional documents have been identified.
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