Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000463673
Ethics application status
Approved
Date submitted
7/09/2005
Date registered
22/09/2005
Date last updated
2/03/2012
Type of registration
Retrospectively registered

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
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patellofemoral Pain Syndrome 580 0
Anterior Knee Pain 581 0
Chondromalacia Patella 582 0
Condition category
Condition code
Musculoskeletal 654 654 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single Blinded Randomised Controlled Trial of 176 anterior knee pain subjects with 4 arms:
1) Foot Orthotics (shaped to contact foot)
2) Foot Orthotics (flat)
3) Physiotherapy (exercises, tape)
4) 1 & 3 combined.
Six sessions with a physiotherapist over a six week period.
Intervention code [1] 401 0
None
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 774 0
Worst and Usual Pain Visual Analogue Scale
Timepoint [1] 774 0
Measured at baseline, 6 weeks, 12 weeks and 52 weeks.
Primary outcome [2] 775 0
Functional Index Questionnaire
Timepoint [2] 775 0
Measured at baseline, 6 weeks, 12 weeks and 52 weeks.
Primary outcome [3] 776 0
Anterior Knee Pain Scale
Timepoint [3] 776 0
Measured at baseline, 6 weeks, 12 weeks and 52 weeks.
Primary outcome [4] 777 0
Patient Perceived Treatment Effect Score
Timepoint [4] 777 0
Measured at baseline, 6 weeks, 12 weeks and 52 weeks.
Primary outcome [5] 778 0
Perceived Global Effect 5pt Scale
Timepoint [5] 778 0
Measured at baseline, 6 weeks, 12 weeks and 52 weeks.
Secondary outcome [1] 1569 0
Physical Activity Level
Timepoint [1] 1569 0
In Previous Week
Secondary outcome [2] 1570 0
Step up, Step down & Squat Tests
Timepoint [2] 1570 0
Measured at baseline, 6 weeks, 12 weeks and 52 weeks.
Secondary outcome [3] 1571 0
Lower Extremity Functional Scale
Timepoint [3] 1571 0
Measured at baseline, 6 weeks, 12 weeks and 52 weeks.
Secondary outcome [4] 1572 0
McGill Pain Questionnaire
Timepoint [4] 1572 0
Measured at baseline, 6 weeks, 12 weeks and 52 weeks.
Secondary outcome [5] 1573 0
SF-36 Health Survey
Timepoint [5] 1573 0
Measured at baseline, 6 weeks, 12 weeks and 52 weeks.
Secondary outcome [6] 1574 0
Hospital Anxiety & Depression Scale
Timepoint [6] 1574 0
Measured at baseline, 6 weeks, 12 weeks and 52 weeks.
Secondary outcome [7] 1575 0
Patient Specific Functional Scale
Timepoint [7] 1575 0
Measured at baseline, 6 weeks, 12 weeks and 52 weeks.
Secondary outcome [8] 1577 0
Pressure Pain Threshold.
Timepoint [8] 1577 0
Measured at baseline, 6 weeks, 12 weeks and 52 weeks.

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
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
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 preludes 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)
Concealed allocation by randomisation over the phone from a central trial unit (Queensland Clinical Trial Centre).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation schedule with no restriction.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
176
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 721 0
Government body
Name [1] 721 0
NHMRC # 301037
Country [1] 721 0
Australia
Funding source category [2] 722 0
Commercial sector/Industry
Name [2] 722 0
Vasyli International
Country [2] 722 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 599 0
Government body
Name [1] 599 0
NHMRC
Address [1] 599 0
Country [1] 599 0
Australia

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35210 0
Address 35210 0
Country 35210 0
Phone 35210 0
Fax 35210 0
Email 35210 0
Contact person for public queries
Name 9590 0
Dr Bill Vicenzino
Address 9590 0
Musculoskeletal Pain and Injury Reserach Unit
Division of Physiotherapy
University of Queensland
St Lucia QLD 4072
Country 9590 0
Australia
Phone 9590 0
+61 7 33654587
Fax 9590 0
Email 9590 0
[email protected]
Contact person for scientific queries
Name 518 0
Dr Bill Vicenzino
Address 518 0
Musculoskeletal Pain and Injury Reserach Unit
Division of Physiotherapy
University of Queensland
St Lucia QLD 4072
Country 518 0
Australia
Phone 518 0
+61 7 33654587
Fax 518 0
Email 518 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.