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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Treatment: Surgery - Foot Orthotics
Treatment: Surgery - Physiotherapy

Treatment: Surgery: Foot Orthotics


Treatment: Surgery: Physiotherapy
Intervention code [1] 0 0
Treatment: Surgery
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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00118521
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00118521