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A Clinical Study in the Use of Orthotics in Treating Pain in the Front of the Knee

Foot Orthotics in the Treatment of Patellofemoral Pain Syndrome: A Randomised Clinical Trial in Primary Care

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00118521
Enrollment
176
Registered
2005-07-11
Start date
2004-05-31
Completion date
2007-06-30
Last updated
2013-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patellofemoral Pain Syndrome

Keywords

Anterior Knee Pain

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.

Detailed description

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.

Interventions

PROCEDUREPhysiotherapy

Sponsors

National Health and Medical Research Council, Australia
CollaboratorOTHER
The University of Queensland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

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

Design outcomes

Primary

MeasureTime frame
Worst and Usual Pain Visual Analogue Scale
Functional Index Questionnaire
Anterior Knee Pain Scale
Patient Perceived Treatment Effect score
Perceived Global Effect 5 Point Scale

Secondary

MeasureTime frame
Physical activity level in previous week
Step up, step down and squat tests
Lower Extremity Functional Scale
McGill Pain Questionnaire
SF-36 Health Survey
Hospital Anxiety and Depression Scale
Patient Specific Functional Scale
Pressure pain threshold

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 5, 2026