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NCT Number: NCT00118521

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

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.

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Key information

Conditions

Patellofemoral Pain Syndrome Joint Diseases Musculoskeletal Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Musculoskeletal Pain & Injury Research Unit, Division of Physiotherapy, The University of Queensland

Brisbane, Queensland, 4072, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Foot Orthotics

Procedure

physiotherapy

Procedure

Primary outcomes

  1. Worst and Usual Pain Visual Analogue Scale

  2. Functional Index Questionnaire

  3. Anterior Knee Pain Scale

  4. Patient Perceived Treatment Effect score

  5. Perceived Global Effect 5 Point Scale

Secondary outcomes

  1. Physical activity level in previous week

  2. Step up, step down and squat tests

  3. Lower Extremity Functional Scale

  4. McGill Pain Questionnaire

  5. SF-36 Health Survey

  6. Hospital Anxiety and Depression Scale

  7. Patient Specific Functional Scale

  8. Pressure pain threshold

Sponsors and collaborators

Lead sponsor

The University of Queensland

Other

Collaborators

  • National Health and Medical Research Council, Australia

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Jul 11, 2005
Registry last updated
Dec 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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