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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
Scientific title
Foot Orthotics in the Treatment of Patellofemoral Pain Syndrome: A Randomised Clinical Trial in Primary Care
Secondary ID [1] 0 0
NHMRC#301037
Secondary ID [2] 0 0
2003001023NHMRC
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patellofemoral Pain Syndrome 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Worst and Usual Pain Visual Analogue Scale
Timepoint [1] 0 0
Primary outcome [2] 0 0
Functional Index Questionnaire
Timepoint [2] 0 0
Primary outcome [3] 0 0
Anterior Knee Pain Scale
Timepoint [3] 0 0
Primary outcome [4] 0 0
Patient Perceived Treatment Effect score
Timepoint [4] 0 0
Primary outcome [5] 0 0
Perceived Global Effect 5 Point Scale
Timepoint [5] 0 0
Secondary outcome [1] 0 0
Physical activity level in previous week
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Step up, step down and squat tests
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Lower Extremity Functional Scale
Timepoint [3] 0 0
Secondary outcome [4] 0 0
McGill Pain Questionnaire
Timepoint [4] 0 0
Secondary outcome [5] 0 0
SF-36 Health Survey
Timepoint [5] 0 0
Secondary outcome [6] 0 0
Hospital Anxiety and Depression Scale
Timepoint [6] 0 0
Secondary outcome [7] 0 0
Patient Specific Functional Scale
Timepoint [7] 0 0
Secondary outcome [8] 0 0
Pressure pain threshold
Timepoint [8] 0 0

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
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2007
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Musculoskeletal Pain & Injury Research Unit, Division of Physiotherapy, The University of Queensland - Brisbane
Recruitment postcode(s) [1] 0 0
4072 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Bill Vicenzino, PhD
Address 0 0
The University of Queensland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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