A Clinical Study in the Use of Orthotics in Treating Pain in the Front of the Knee
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|ClinicalTrials.gov Identifier: NCT00118521|
Recruitment Status : Completed
First Posted : July 11, 2005
Last Update Posted : December 19, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Patellofemoral Pain Syndrome||Procedure: Foot Orthotics Procedure: Physiotherapy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||176 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Foot Orthotics in the Treatment of Patellofemoral Pain Syndrome: A Randomised Clinical Trial in Primary Care|
|Study Start Date :||May 2004|
|Primary Completion Date :||June 2007|
|Study Completion Date :||June 2007|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00118521
|Musculoskeletal Pain & Injury Research Unit, Division of Physiotherapy, The University of Queensland|
|Brisbane, Queensland, Australia, 4072|
|Principal Investigator:||Bill Vicenzino, PhD||The University of Queensland|