A Clinical Study in the Use of Orthotics in Treating Pain in the Front of the Knee
Recruitment status was Active, not recruiting
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Patellofemoral Pain Syndrome |
Procedure: Foot Orthotics Procedure: Physiotherapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment |
| Official Title: | Foot Orthotics in the Treatment of Patellofemoral Pain Syndrome: A Randomised Clinical Trial in Primary Care |
- 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
| Estimated Enrollment: | 176 |
| Study Start Date: | May 2004 |
| Estimated Study Completion Date: | May 2007 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Australia, Queensland | |
| 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 |
More Information
No publications provided by The University of Queensland
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00118521 History of Changes |
| Other Study ID Numbers: | 2003001023NHMRC, NHMRC#301037 |
| Study First Received: | July 1, 2005 |
| Last Updated: | August 3, 2011 |
| Health Authority: | Australia: Human Research Ethics Committee |
Keywords provided by The University of Queensland:
|
Anterior Knee Pain |
Additional relevant MeSH terms:
|
Somatoform Disorders Patellofemoral Pain Syndrome Mental Disorders Joint Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on June 18, 2013