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

Patellofemoral Pain Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00118521
• Other study ID #: 2003001023NHMRC
• Secondary ID: NHMRC#301037
• Status: Completed
• Phase: Phase 3
• First received: July 1, 2005
• Last updated: December 18, 2013
• Start date: May 2004
• Est. completion date: June 2007

Study information

• Verified date: September 2006
• Source: The University of Queensland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Patellofemoral Pain Syndrome

Intervention

Procedure:
• Foot Orthotics

• Physiotherapy

Locations

Country	Name	City	State
Australia	Musculoskeletal Pain & Injury Research Unit, Division of Physiotherapy, The University of Queensland	Brisbane	Queensland

Sponsors (2)

Lead Sponsor	Collaborator
The University of Queensland	National Health and Medical Research Council, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Worst and Usual Pain Visual Analogue Scale
Primary	Functional Index Questionnaire
Primary	Anterior Knee Pain Scale
Primary	Patient Perceived Treatment Effect score
Primary	Perceived Global Effect 5 Point Scale
Secondary	Physical activity level in previous week
Secondary	Step up, step down and squat tests
Secondary	Lower Extremity Functional Scale
Secondary	McGill Pain Questionnaire
Secondary	SF-36 Health Survey
Secondary	Hospital Anxiety and Depression Scale
Secondary	Patient Specific Functional Scale
Secondary	Pressure pain threshold